Search Result

Your search for All Network Trials resulted in 33 trials.

A 3-Arm Randomized Phase II Trial of Bendamustine-Rituximab (BR) Followed by Rituximab vs. Bortezomib-BR (BVR) Followed by Rituximab vs. BR Followed by Lenalidomide/Rituximab in High Risk Follicular Lymphoma (ECOG-E2408)

Cancer Types:  Non-Hodgkin's Lymphoma
Member Institutions:  Ephrata Hospital, Hematology & Oncology Associates of NE PA

Purpose:  Primary objectives: - To compare the complete remission (CR) rate of BR versus BVR as induction therapy. - To compare the 1-year post-induction disease-free survival (DFS) rate with rituximab plus lenalidomide to rituximab alone as continuation therapy. Secondary objectives: - To determine the 3-year progression-free survival (PFS) and the 5-year overall survival (OS) with BR, BVR, lenalidomide plus rituximab, and rituximab alone. - To evaluate patient-reported outcomes at baseline and during treatment to determine differences in symptom palliation, treatment-related symptoms and overall health-related quality of life (HRQL) according to treatment arm. - To examine the association between baseline FLIPI information and outcome (CR, DFS, PFS, and OS). - To examine the association between baseline and end-of-treatment patient comorbidities assessed by the Cumulative Illness Rating Scale (CIRS) and outcome (CR, DFS, PFS, and OS). - To create an image and tissue bank including serial PET/CT scans, diagnostic paraffin-embedded tissue, germline DNA, and serial blood and bone marrow samples sufficient to support proposed and future studies of tumor and host characteristics that may predict for clinical outcome, including treatment arm effects, and enhance existing prognostic indices.
Eligibillity:  Ages Eligible for Study: 18 and older
Both Genders Eligible for the Study

DISEASE CHARACTERISTICS:

• Histologically confirmed (biopsy-proven) diagnosis of follicular B-cell non-Hodgkin lymphoma with no evidence of transformation to large cell histology
o Patients having both diffuse and follicular architectural elements are eligible if the histology is predominantly follicular (i.e., ≥ 50% of the cross-sectional area) and there is no evidence of transformation to a large cell histology
o Diagnostic confirmation (i.e., core needle or excisional lymph node biopsy) required if the interval since tissue diagnosis of low-grade malignant lymphoma is > 24 months
 Bone marrow biopsy alone not acceptable

• Stage II, III, or IV AND grade 1, 2, or 3a disease

• Must meet criteria for High Tumor Burden (higher risk) as defined by either the Groupe D'Etude des Lymphomes Follicularies (GELF) criteria OR the follicular lymphoma international prognostic index (FLIPI) as defined below:
o Patient must meet ≥ 1 of the following GELF criteria:
 Nodal or extranodal mass ≥ 7 cm
 At least 3 nodal masses > 3.0 cm in diameter
 Systemic symptoms due to lymphoma or B symptoms
 Splenomegaly with spleen > 16 cm by CT scan
 Evidence of compression syndrome (e.g., ureteral, orbital, gastrointestinal) or pleural or peritoneal serous effusion due to lymphoma (irrespective of cell content)
 Leukemic presentation (≥ 5.0 x 10^9/L malignant circulating follicular cells)
&#61607; Cytopenias (polymorphonuclear leukocytes < 1.0 X 10^9/L, hemoglobin < 10 g/dL, and/or platelets < 100 x 10^9/L)
o Patient must have a FLIPI-1 score of 3, 4, or 5 (1 point per criterion below):
&#61607; Age &#8805; 60 years
&#61607; Stage III-IV disease
&#61607; Hemoglobin level < 12 g/dL
&#61607; > 4 nodal areas
&#61607; Serum LDH level above normal

• At least 1 objective measurable disease parameter
o Baseline measurements and evaluations (PET and CT) obtained within 6 weeks of randomization
o Measurable disease in the liver is required if the liver is the only site of lymphoma

PATIENT CHARACTERISTICS:

• See Disease Characteristics

• ECOG performance status 0-2

• ANC &#8805; 1,500/mm³ (includes neutrophils and bands)

• Platelet count &#8805; 100,000/mm³

• Creatinine &#8804; 2.0 mg/dL

• AST and ALT &#8804; 5 x upper limit of normal (ULN)

• Alkaline phosphatase &#8804; 5 x ULN

• Total bilirubin &#8804; 1.5 x ULN (patients with known Gilbert disease should contact the study PI)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use 2 effective methods (1 highly effective and 1 additional effective method) of contraception &#8805; 28 days before, during, and for &#8805; 28 days after completing study treatment

• HIV-positive patients must meet all of the following criteria:
o HIV is sensitive to antiretroviral therapy
o Must be willing to take effective antiretroviral therapy if indicated
o No history of CD4 < 300 cells/mm³ prior to or at the time of lymphoma diagnosis
o No history of AIDS-defining conditions
o If on antiretroviral therapy, must not be taking zidovudine or stavudine
o Must be willing to take prophylaxis for Pneumocystis jiroveci pneumonia (PCP) during therapy and &#8805; 2 months following completion of study therapy or until the CD4 cells recover to over 250 cells/mm³

• No recent history of malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for &#8805; 2 years

• No active, uncontrolled infections (afebrile for > 48 hours off antibiotics)

• No &#8805; grade 2 neuropathy

• No myocardial infarction within the past 6 months

• No NYHA class III-IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities

• No serious medical or psychiatric illness likely to interfere with participation in this clinical study

• No known hypersensitivity to boron or mannitol

• No chronic carriers of hepatitis B virus (HBV) with positive hepatitis surface antigen (HBsAg +)
o Patients with a prior history of HBV infection, but immune, with only IgG hepatitis core antibody positive (HBcAb+), must receive antiviral prophylaxis (e.g., lamivudine 100 mg po daily) for &#8805; 1 week prior to course 1 and throughout induction and continuation therapy and for &#8805; 9 months after the last rituximab dose

• Must register into the mandatory RevAssist® program and be willing and able to comply with the requirements of RevAssist® (for patients randomized to arm III)

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy, radiotherapy, or immunotherapy for lymphoma
o Prednisone or other corticosteroids used for non-lymphomatous conditions will not be considered as prior chemotherapy
o Prior/recent short course (< 2 weeks) of steroids for symptom relief of lymphoma-related symptoms is allowed
Treatment:  Arm A - BENDAMUSTINE-RITUXIMAB (BR) INDUCTION FOLLOWED BY RITUXIMAB CONTINUATION (ARM D)
• Rituximab 375 mg/m2 IV 1 Every 28 days
• Bendamustine 90 mg/m2 IV 1 and 2 Every 28 days
• Repeat cycles every 28 days for a total of 6 cycles.

Arm D -Rituximab Continuation
• Rituximab 375 mg/m2 IV 1 Every 8 weeks (56 days) ; repeat rituximab dosing every 8 weeks for 2 years (a total of 12 rituximab doses).

Arm B - BENDAMUSTINE, RITUXIMAB-BORTEZOMIB (BVR) INDUCTION
FOLLOWED BY RITUXIMAB CONTINUATION (ARM E)
• Rituximab 375 mg/m2 IV d 1 Every 28 days
• Bortezomib 1.3 mg/m2 IV d 1, 4, 8, and 11 Every 28 days
• Bendamustine 90 mg/m2 IV d 1 and 4 Every 28 days
• Repeat cycles every 28 days for a total of 6 cycles.

Arm E - Rituximab Continuation
• Rituximab 375 mg/m2 IV 1 Every 8 weeks (56 days)
• Repeat rituximab dosing every 8 weeks for 2 years (a total of
12 rituximab doses).

Arm C - BENDAMUSTINE-RITUXIMAB (BR) INDUCTION FOLLOWED BY
LENALIDOMIDE AND RITUXIMAB CONTINUATION (ARM F).
• Rituximab* 375 mg/m2 IV 1 Every 28 days
• Bendamustine 90 mg/m2 IV 1 and 2 Every 28 days
• Repeat cycles every 28 days for a total of 6 cycles.

Arm F - Lenalidomide/Rituximab Continuation
• Lenalidomide** 20 mg PO 1 through 21 Every 28 days
• Rituximab*** 375 mg/m2 IV 1 Every 8 weeks (56 days)
• Repeat rituximab dosing every 8 weeks for 2 years (a total of 12 rituximab doses).
• Lenalidomide therapy is given every 4 weeks for a total of 13 cycles.
 

Ancillary Laboratory Protocol for Collecting Diagnostic Material on Patients Considered for ECOG Treatment Trials for Leukemia or Related Hematologic Disorders (ECOG-E3903)

Cancer Types:  Leukemia, not otherwise specified
Member Institutions:  Hematology & Oncology Associates of NE PA

Purpose:  To provide a mechanism for sample collection for diagnostic review to determine eligibility of patients for accrual to the Eastern Cooperative Oncology Group (ECOG) leukemia trials.
Eligibillity:  - Patients must be considered for enrollment into one or more ECOG treatment trials for acute or chronic leukemia
- Patients must not yet have started treatment on their respective ECOG treatment trial
Treatment:  N/A – Specimen Collection
 

Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial (RTOG-0924)

Cancer Types:  Prostate
Member Institutions:  Hudson Valley Oncology Associates, Northeast Radiation Oncology Center, Sparta Cancer Treatment Center, Upper Delaware Valley Cancer Center

Purpose:  Demonstrate that prophylactic neoadjuvant androgen deprivation therapy (NADT) and whole-pelvic radiation therapy (WPRT) will result in improvement in overall survival (OS) in patients with “unfavorable” intermediate risk or “favorable” high risk prostate cancer compared to NADT and high dose prostate and seminal vesicle (SV) radiation therapy (P + SV RT) using intensity modulated radiotherapy (IMRT) or EBRT with a high dose rate (HDR) or a permanent prostate (radioactive seed) implant (PPI) boost.
Eligibillity:  Inclusion Criteria:
• Histologic proven diagnosis of adenocarcinoma of the prostate
• Patient at moderate to high risk for recurrence as determined by one of the following combinations (Gleason 7-10 + T1c- T2b; Gleason 6 +T2c-T4; Gleason 6 +T1b-T2b + PSA > 20ng/ml
• Zubrod performance status 0 or 1
• No previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
• No previous pelvic irradiation, prostate brachytherapy or bilateral orchiectomy
• No previous or concurrent cytotoxic chemotherapy for prostate cancer
Treatment:  Arm 1: Neoadjuvant androgen deprivation therapy + prostate & seminal vesicle RT + boost to prostate & proximal seminal vesicles

Arm 2: Neoadjuvant Androgen Deprivation Therapy + whole-pelvic RT + boost to prostate & proximal seminal vesicles
 

A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer (NSABP B-49)

Cancer Types:  Breast - Female
Member Institutions:  Associates in Hematology-Oncology, PC, Ephrata Hospital, Hematology & Oncology Associates of NE PA, Riddle Hospital, Sparta Cancer Treatment Center

Purpose:  To compare the value of a non-anthracycline-based chemotherapy regimen relative to anthracycline-based chemotherapy regimens in women with resected node-positive or high-risk node-negative, HER2-negative breast cancer.
Eligibillity:  DISEASE CHARACTERISTICS:
1) The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
2) The breast cancer must be HER2-negative based on current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer
a) If the result of the in situ hybridization testing (fluorescence in situ hybridization [FISH], chromagen in situ hybridization [CISH], or other) is equivocal, the patient is eligible if there is no plan to administer HER2-targeted therapy
3) All of the following staging criteria must be met according to AJCC criteria:
a) By pathologic evaluation, primary tumor must be pT1-3
b) By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b
c) If pN0, at least one of the following criteria must be met:
i) Estrogen receptor (ER) negative AND progesterone receptor (PgR) negative
ii) Pathologic tumor size > 2.0 cm
iii) T1c (pathologic tumor size > 1.0 cm but &#8804; 2.0 cm) and ER positive (PgR status may be positive or negative) and either grade 3 histology or Oncotype DX® Recurrence Score of &#8805; 25
d) No T4 tumors, including inflammatory breast cancer
4) No definitive clinical or radiologic evidence of metastatic disease
5) No synchronous or previous contralateral invasive breast cancer (patients with synchronous and/or previous contralateral ductal carcinoma in situ [DCIS] are eligible)
6) No history of ipsilateral invasive breast cancer or ipsilateral DCIS
7) Patients must have undergone either a total mastectomy or breast-conserving surgery (lumpectomy)
a) For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and ductal cancer in situ (DCIS) as determined by the local pathologist
i) If pathologic examination demonstrates tumor at the line of resection, additional operative procedures must be performed to obtain clear margins
ii) If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible
b) Patients with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection
c) For patients who undergo mastectomy, margins must be histologically free of invasive tumor and DCIS
8) Patients must have completed one of the following procedures for evaluation of pathologic nodal status:
a) Sentinel lymphadenectomy alone if pathologic nodal staging based on sentinel lymphadenectomy is pN0, pN1mi, or pN1b
b) Sentinel lymphadenectomy alone if pathologic nodal staging based on sentinel lymphadenectomy is pN1a limited to 1 or 2 positive nodes and primary tumor is T1 or T2 by pathologic evaluation
c) Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive
d) Axillary lymphadenectomy with or without SN isolation procedure
9) The interval between the last surgery for breast cancer (treatment or staging) and randomization must be no more than 84 days
10) Patients must have ER analysis performed on the primary tumor prior to randomization
a) If negative for ER, assessment of PgR must also be performed
b) Either a core biopsy or surgical resection specimen can be used for ER/PgR testing

PATIENT CHARACTERISTICS:
1) ECOG performance status of 0 or 1
2) ANC must be &#8805; 1,200/mm³
3) Platelet count must be &#8805; 100,000/mm³
4) Hemoglobin must be &#8805; 10 g/dL
5) Total bilirubin must be &#8804; upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert disease or similar syndrome involving slow conjugation of bilirubin
6) Alkaline phosphatase (AP) must be &#8804; 2.5 x ULN for the lab
7) Aspartate transaminase (AST) must be &#8804; 1.5 x ULN for the lab
a) If alanine aminotransferase (ALT) is performed instead of AST (per institution's standard practice), the ALT value must be &#8804; 1.5 x ULN; if both were performed, the AST must be &#8804; 1.5 x ULN
b) Patients with AST or AP > ULN are eligible for inclusion in the study if liver imaging (computed tomography [CT], magnetic resonance imaging [MRI ], positron emission tomography [PET ]-CT, or PET scan performed within 90 days prior to randomization) does not demonstrate metastatic disease and the requirements above are met
c) Patients with AP that is > ULN but &#8804; 2.5 x ULN are eligible for inclusion in the study if a bone scan, PET-CT scan, or PET scan performed within 90 days prior to randomization does not demonstrate metastatic disease
d) AP and AST may not both be > the ULN; For example, if the AP is > the ULN but &#8804; 2.5 x ULN, then the AST must be &#8804; the ULN or if the AST is > the ULN but &#8804; 1.5 x ULN, then the AP must be &#8804; ULN
8) Serum creatinine must be &#8804; ULN for the lab
9) Left ventricular ejection fraction (LVEF) must be &#8805; 50% at assessment by 2-D echocardiogram or multigated acquisition (MUGA) scan regardless of the facility's lower limit of normal (LLN)
10) No history of non-breast malignancies within 5 years prior to randomization, except for the following: carcinoma in situ of the cervix, colorectal carcinoma in situ, melanoma in situ, and basal cell and squamous cell carcinomas of the skin
11) No known active hepatitis B or hepatitis C with abnormal liver function tests
12) No cardiac disease (history of and/or active disease) that would preclude the use of the study drugs including, but not confined to:
a) Active cardiac disease
i) Angina pectoris that requires the use of anti-anginal medication
ii) Ventricular arrhythmias except for benign premature ventricular contractions
iii) Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication
iv) Conduction abnormality requiring a pacemaker
v) Valvular disease with documented compromise in cardiac function
vi) Symptomatic pericarditis
b) History of cardiac disease
i) Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function
ii) History of documented congestive heart failure (CHF)
iii) Documented cardiomyopathy
13) No intrinsic lung disease resulting in dyspnea
14) No unstable diabetes mellitus
15) No active infection or chronic infection requiring suppressive antibiotics
16) No nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) &#8805; grade 2, per the Common Terminology Criteria for Adverse Events [CTCAE] v4.0
17) No conditions that would prohibit administration of corticosteroids
18) No history of hypersensitivity reaction to drugs formulated with polysorbate 80
19) No other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up
20) No psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
21) No pregnancy or lactation at the time of study entry
22) Pregnancy testing must be performed within 2 weeks prior to randomization according to institutional standards for women of childbearing potential

PRIOR CONCURRENT THERAPY:
1) See Disease Characteristics
2) No previous therapy with anthracyclines or taxanes for any malignancy
3) No chemotherapy administered for the currently diagnosed breast cancer prior to randomization
4) No continued endocrine therapy such as raloxifene or tamoxifen (or other selective estrogen receptor modulator [SERM]) or an aromatase inhibitor
a) Patients are eligible if these medications are discontinued prior to randomization
5) No concurrent sex hormonal therapy, e.g., birth control pills or ovarian hormone replacement therapy
a) Patients are eligible if these medications are discontinued prior to randomization
6) No whole breast radiotherapy (RT) prior to randomization or partial breast RT that cannot be completed on or before the date of randomization
7) No history of a major organ allograft or condition requiring chronic immunosuppression, e.g., kidney, liver, lung, heart, bone marrow transplant, or autoimmune diseases
a) Patients who have received corneal transplants, cadaver skin, or bone transplants are eligible
8) No chronic daily treatment with corticosteroids (dose of &#8805; 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids)
9) No use of any investigational product within 30 days prior to randomization
10) Administration of targeted therapy for cancer is prohibited
Treatment:  Patients will be randomized to an anthracycline-containing arm or a non-anthracycline containing arm. After randomization, the treating physician will decide which specific treatment the patient will receive. If randomized to the anthracycline-containing arm, the choices are TAC (Docetaxel, doxorubicin, and cyclophosphamide), AC (Doxorubicin and cyclophosphamide) followed by weekly paclitaxel, dose dense AC followed by weekly paclitaxel or dose dense AC followed by dose dense paclitaxel. In the non-anthracycline containing arm, patients will receive docetaxel and cyclophosphamide.
 

A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy (NSABP-B-43)

Cancer Types:  Breast - Female
Member Institutions:  Albert Einstein Medical Center, Associates in Hematology-Oncology, PC, Ephrata Hospital, Hematology & Oncology Associates of NE PA, Mercy Suburban Hospital, Northeast Radiation Oncology Center, Pocono Medical Center, Riddle Hospital, Sacred Heart Hospital, Sparta Cancer Treatment Center

Purpose:  To determine the value of trastuzumab given during radiation therapy (RT) compared to RT alone in preventing the subsequent occurrence of ipsilateral breast cancer recurrence, ipsilateral skin cancer recurrence, or ipsilateral ductal carcinoma insitu (DCIS) in women with HER2-positive DCIS resected by lumpectomy
Eligibillity:  •Patients must be female.

•Patients must be 18 years of age or older.

•Patients must have an ECOG performance status of 0 or 1

•On histologic examination, the tumor must be ductal carcinoma in situ (DCIS). (Patients with mixed DCIS and lobular carcinoma in situ [LCIS] are eligible.)

•The DCIS must be HER2-positive as determined by central testing.

•Estrogen and/or progesterone receptor status must be determined prior to randomization.

•All DCIS must have been resected by lumpectomy.

•The margins of the resected specimen must be histologically free of DCIS.

•If axillary staging is performed, nodal staging must be pN0, pN0 (i–), pN0(i+) which is defined as isolated tumor cells &#8804; 0.2 mm, regardless of the method of detection, i.e., IHC or H&E, pN0 (mo l–), or pN0(mol+).

•The interval between the last surgery for excision of DCIS (lumpectomy or reexcision of lumpectomy margins) and randomization must be no more than 120 days.
Treatment:  Group 1: Radiation Therapy
Group 2: Radiation Therapy + Trastuzumab x 2 doses Dose 1: 8 mg/kg IV Dose 2: 6 mg/kg IV given 3 weeks after Dose 1
 

A Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer also Receiving Cisplatin and Etoposide (CALGB-30610/RTOG-0538)

Cancer Types:  Lung
Member Institutions:  Aria Health, Mercy Fitzgerald Hospital, Pocono Medical Center, Riddle Hospital

Purpose:  To determine whether administering high dose thoracic radiotherapy, 70 Gy (2 Gy once-daily over 7 weeks) or 61.2 Gy (1.8 Gy once-daily for 16 days followed by 1.8 Gy twice-daily for 9 days), will improve median and 2-year survival compared with 45 Gy (1.5 Gy twice-daily over 3 weeks) in patients with limited stage small cell lung cancer.
Eligibillity:  *Histologically or cytologically documented SCLC
*Limited stage disease: one hemithorax with regional lymph node metastases, including ipsilateral hilar, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular lymph nodes
*No prior chemo or radiation; and no complete resection for SCLC
Treatment:  Arm A XRT 45 Gy BID M-F x 3wks
Arm B XRT 70 Gy Q day M-F x 7wks
Arm C XRT 61.2 Gy Concomitant boost: Q day M-F x 16 days; then BID M-F x 9 days
All 4, 21 day cycles of Chemo (Cisplatin 80mg/m² d1 q cycle, Etoposide 100 mg/m² d1, d2, & d3 q cycle)
 

A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy with or without Short Term Androgen Deprivation Therapy for Patients with Intermediate Risk Prostate Cancer (RTOG-0815)

Cancer Types:  Prostate
Member Institutions:  Albert Einstein Medical Center, Aria Health, Hudson Valley Oncology Associates, Mercy Fitzgerald Hospital, Northeast Radiation Oncology Center, Sparta Cancer Treatment Center, Upper Delaware Valley Cancer Center

Purpose:  For patients with intermediate risk prostate cancer, this trial will utilize dose escalated radiotherapy with or without short term androgen deprivation therapy
Eligibillity:  Pathologically proven diagnosis of prostatic adenocarcinoma withint 6 months prior to registration; negative lymph nodes as established by imaging; no evidence of bone metastases on bone scan 60 days prior to registration; H&P 60 days prior to registration; Zubrod Performance status 0-1; Age greater than or equal to 18; Baseline serum PSA value performed with an FDA approved assay; CBC/differential obtained 60 days prior to registration; patient must be able to provide study specific informed consent prior to study entry.
Treatment:  Two treatment groups:
1. Patients who receive radiation therapy only
2. Patients who receive radiation therapy plus hormone therapy
 

A Phase III Randomized, Double-Blind Trial of Chemoembolization with or without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients with and without Vascular Invasion (ECOG-E1208)

Cancer Types:  Liver
Member Institutions:  Albert Einstein Medical Center, Mercy Fitzgerald Hospital

Purpose:  To compare Progression-Free Survival (PFS) of chemoembolization alone to sorafenib in combination with chemoembolization.
Eligibillity:  Patients must have a diagnosis of hepatocellular carcinoma by at least one criterion listed below:
• Histologically confirmed
• Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT) consistent with liver cirrhosis AND at least one solid liver lesion > 2cm with early enhancement and delayed enhancement washout regardless of alpha-feto protein levels (AFP).
• AFP > 400ng/mL AND evidence of at least one solid liver lesion > 2cm regardless of specific imaging characteristics on CT or MRI
• Patients must have HCC limited to the liver. There must be no clinical or radiographic evidence of extrahepatic HCC.
• Portal Lymphadenopathy IS permitted for patients with HBV or HCV – as lymphadenopathy is commonly associated with hepatitis unrelated to malignancy.
• Patients must have measurable disease as defined in Section 6.1.1 constituting < 50% of liver parenchyma within 4 weeks of registration
Treatment:  Arm A - Sorafenib and chemoembolization
Arm B - placebo and chemoembolization
 

A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon a-2b for Resected High-Risk Melanoma (ECOG-E1609)

Cancer Types:  Melanoma, skin
Member Institutions:  Pocono Medical Center, Riddle Hospital

Purpose:  1. First Co-primary Endpoint: To evaluate recurrence-free survival (RFS) between patients randomized to receive post-operative adjuvant ipilimumab versus those randomized to receive HDI. 2. Second Co-primary Endpoint: To evaluate overall survival (OS) between patients randomized to receive post-operative adjuvant ipilimumab versus those randomized to receive HDI.
Eligibillity:  • All patients must have disease that is completely surgically resected in order to be eligible. Patients must have been surgically rendered free of disease with negative margins on resected specimen. Patients rendered free of disease by non-surgical means are not eligible.
• All patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization.
• Patients must be staged as either IIIB, IIIC, IV
• Patients with disease recurrence after adequate surgical excision of the original primary cutaneous melanoma are allowed
Treatment:  Arm A: Induction: Ipilimumab intravenous infusion once every 21 days for a total of 4 doses. Maintenance: Ipilimumab intravenous infusion once every 12 weeks (3 months), beginning at week 24, for a maximum of 4 doses

Arm B: Induction: Interferon Alfa-2b intravenous infusion for 5 consecutive days out of 7 (e.g., Monday through Friday) every week for a total of 4 weeks. Maintenance: Interferon Alfa-2b subcutaneous injection every other day (e.g., Monday, Wednesday, Friday) three times a week for 48 weeks
 

A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Sensitive Prostate Cancer (SWOG-S1216)

Cancer Types:  Prostate
Member Institutions:  Sparta Cancer Treatment Center

Purpose:  The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide.
Eligibillity:  INCLUSION CRITERIA:
1) Clinical diagnosis of metastatic prostate cancer.
2) Serum testosterone within institutional limits of normal.
3) PSA &#8805; 2 ng/mL within 90 days prior to initiation of androgen deprivation. therapy (for early induction) or prior to registration (for late induction).
4) DEXA scan within 2 years prior to registration.
5) ECG within 42 days prior to registration and QTc interval &#8804; 460 msec.
6) LVEF within 42 days prior to registration and within institutional limits of normal.
7) Adequate hepatic function as evidenced by bilirubin &#8804; 2 x institutional upper limit of normal (ULN), SGOT (AST) and SGPT (ALT) &#8804; 3 x institutional ULN, or &#8804; 5 x institutional ULN if liver metastases are present.
8) Adequate renal function as evidenced by calculated creatinine clearance &#8805; 40 mL/min.
9) Adequate hematologic function as evidenced by leukocytes &#8805; 3,000/mcL, absolute neutrophil count (ANC) &#8805; 1,500/mcL, hemoglobin &#8805; 9 g/dL, and platelets &#8805; 100,000/mcL.
10) Zubrod performance status of 0 - 2. Zubrod performance status 3 will be allowed if from bone pain only.
11) &#8805; 18 years of age.
12) Men of reproduction potential and those who are surgically sterilized (i.e., postvasectomy) must agree to practice effective barrier contraception or agree to abstain from intercourse while receiving treatment on this study and for at least 4 months after protocol treatment ends.

EXCLUSION CRITERIA:
1) Known brain metastases.
2) No more than 36 months of prior neoadjuvant and/or adjuvant hormonal therapy.
3) &#8805; 6 months since completion of androgen deprivation therapy.
4) Prior or concurrent therapy with ketoconazole, aminoglutethimide or abiraterone acetate, or enzalutamide (MDV3100). Concurrent megestrol for hot flashes is allowed.
5) Prior chemotherapy for treatment of metastatic prostate cancer. Prior chemotherapy in the neoadjuvant or adjuvant setting is allowed.
6) &#8805; 2 years since completion of chemotherapy in the neoadjuvant or adjuvant setting.
7) Concurrent use of experimental therapy is not allowed.
8) &#8805; 30 days since prior medical castration for metastatic prostate cancer.
9) If method of castration is a LHRH agonist, the patient must be willing to continue the use of LHRH and add bicalutamide or TAK-700 during protocol treatment.
10) If the patient was on an antiandrogen (e.g. bicalutamide, flutamide), the patient must be willing to switch over to bicalutamide or TAK-700 (according to randomization).
11) Prior bilateral orchiectomy.
12) Concurrent use of LHRH antagonists (e.g. Degarelix)
13) Grade III/IV cardiac disease (as defined by the NYHA Criteria), thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia.
14) Uncontrolled hypertension (defined as blood pressure > 160 mmHg systolic and > 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the Screening visit) despite appropriate medical therapy.
15) Known human immunodeficiency virus (HIV)infection, active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study.
16) History of primary and secondary adrenal insufficiency.
17) Hypersensitivity to TAK-700, to TAK-700 metabolites, to bicalutamide, or to LHRH agonists.
18) Gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of TAK-700, including difficulty swallowing oral medications.
19) No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
Treatment:  Experimental: ADT + TAK-700
LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 2.5 mg of Leuprolide IM every 3 months.
TAK-700, 300 mg, PO, twice daily

Active Comparator: ADT + Bicalutamide
LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 2.5 mg of Leuprolide IM every 3 months.
Bicalutamide, 50 mg, PO, q daily
 

A Phase III Randomized Trial of Adjuvant Chemotherapy with or without Bevacizumab for Patients with Completely Resected Stage 1B (> 4cm) –IIIA Non Small Cell Lung Cancer (NSCLC) (ECOG-E1505)

Cancer Types:  Lung
Member Institutions:  Associates in Hematology-Oncology, PC, Ephrata Hospital, Hematology & Oncology Associates of NE PA, Mercy Fitzgerald Hospital, Pocono Medical Center, Riddle Hospital, Sparta Cancer Treatment Center

Purpose:  Primary * Compare overall survival of patients with completely resected stage IB (tumors &#8805; 4cm)-IIIA non-small cell lung cancer treated with adjuvant chemotherapy with or without bevacizumab. Secondary * Compare disease-free survival of patients treated with these regimens. * Compare the toxicity of these regimens in these patients. * Perform analyses of tissue and blood to establish factors that predict clinical outcome in patients treated with these regimens. * Determine whether smoking status is linked to outcome in these patients.
Eligibillity:  * 6 wks < 12 wks post-thoracotomy
* No prior systemic chemo
* No prior hormones or radiation within 5 yrs
Treatment:  * Arm A - 1 of 3 regimens at discretion of investigator

* Arm B - 1 of 3 regimens with Bevicizumab 15 mg/kg
 

A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer (ECOG-E1305)

Cancer Types:  Lip, Oral Cavity, and Pharynx
Member Institutions:  Associates in Hematology-Oncology, PC, Hematology & Oncology Associates of NE PA, Pocono Medical Center, Riddle Hospital

Purpose:  To compare the overall survival of patients with recurrent or metastatic head and neck cancer treated with standard Cisplatin-based chemotherapy with or without Bevacizumab.
Eligibillity:  Patients must have histologically or cytologically confirmed Squamous Cell Cancer of the Head and Neck (SCCHN), from any primary site that is either (a) recurrent, judged incurable by surgery or radiation or (b) metastatic (no brain metastases). No nasopharyngeal carcinoma of histologic types WHO 2 or 3 or squamous cell carcinoma that originated in the skin.
No prior chemotherapy or biologic/molecular targeted therapy for recurrent or metastatic SCCHN.
Performance Status 0-1
Treatment:  Arm A - Chemo alone for 6 cycles
Arm B - Chemo for 6 cycles with Bevacizumab 15 mg/kg IV, day 1 of each cycle. Bevacizumab is continues after chemo until progression.
Chemo choices:
1. Cisplatin+5-FU (Cisplatin 100 mg/m2 IV over 1-2 hours on day 1, followed by 5-FU 1000 mg/m2 /day as a continuous infusion x 4 days.)
2. Docetaxel + Cisplatin (Docetaxel 75 mg/m2 IV over 1 hour, day 1, followed by Cisplatin 75 mg/m2 IV over 1-2 hours, day 1.)
 

A Phase III Study of Post-Operative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer (RTOG-0920)

Cancer Types:  Lip, Oral Cavity, and Pharynx, Larynx
Member Institutions:  Albert Einstein Medical Center, Mercy Fitzgerald Hospital, Northeast Radiation Oncology Center, Pocono Medical Center, Riddle Hospital, Sparta Cancer Treatment Center

Purpose:  Radiation +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer Test whether the addition of cetuximab to radiation therapy will improve overall survival (OS) in postoperative patients with intermediate risk following surgery
Eligibillity:  Eligibility

• Pathologically (histologically) proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma NOS, etc.) of the head/neck (oral cavity, oropharynx or larynx); Note: Hypopharynx primaries are excluded because these patients have both a poor prognosis and high likelihood of post-radiation complications.
• Clinical stage T1, N1-2 or T2-3, N0-2, M0 including no distant metastases, based upon the following minimum diagnostic workup
• Gross total resection of the primary tumor with curative intent must be completed within 7 weeks of registration with surgical pathology demonstrating one or more of the following “intermediate” risk factors
- Perineural invasion;
- Lymphovascular invasion;
- Single lymph node > 3 cm or &#8805; 2 lymph nodes (all < 6 cm) [no extracapsular extension];
- Close margin(s) of resection, defined as cancer extending to within 5 mm of a surgical margin;
- T3 or microscopic T4a primary tumor (Note: Gross T4a or T4b is ineligible);
- T2 oral cavity cancer with > 5 mm depth of invasion.
Ineligibility
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated < 3 years ago.
• Patients with simultaneous primaries or bilateral tumors are excluded.
• Per the operative report, positive margin(s) [defined as tumor present at the cut or inked edge of the tumor], nodal extracapsular extension, and/or gross residual disease after surgery;
• Prior systemic chemotherapy or anti-EGF therapy for the study cancer; note: prior chemotherapy or anti-EGF therapy for a different cancer is allowable. See section 3.2.1.
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Treatment:  Patients will be randomized into one of two groups:

Group 1:
- Radiation therapy once a day, Monday - Friday, for about 6 weeks

Group 2:
- Initial dose of cetuximab (no radiation therapy this week)
- Then following week: Radiation therapy once a day, Monday - Friday, for about 6 weeks and cetuximab once a week for 6 weeks
- After radiation therapy, cetuximab once a week for 4 weeks
(A total of 11 doses of cetuximab)
 

A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients With Resected Head of Pancreas Adenocarcinoma (RTOG-0848)

Cancer Types:  Pancreas
Member Institutions:  Aria Health, Mercy Fitzgerald Hospital, Northeast Radiation Oncology Center, Riddle Hospital, Sparta Cancer Treatment Center

Purpose:  To determine whether the addition of erlotinib to gemcitabine adjuvant chemotherapy improves survival as compared to gemcitabine alone following R0 or R1 resection of head of pancreas adenocarcinoma (including adenocarcinoma of the head, neck, and uncinate process).
Eligibillity:  Conditions for Patient Eligibility
• Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection (i.e., removal of all gross tumor) involving a classic pancreaticoduodenectomy (Whipple) or a pylorus preserving pancreaticoduodenectomy. Patients with invasive adenocarcinoma that also contains a component of intraductal papillary mucinous neoplasm (IPMN) are eligible
• The operating surgeon must document in the operative note that a complete gross excision of the primary tumor was achieved. The pathology report must include documentation of the margin status and the size of the tumor. The pathology report must also include the status of the three major margins—bile duct, pancreatic parenchyma, and retroperitoneal (uncinate).
• Interval between definitive tumor-related surgery and 1 ststep registration between 21-56 days.
• Patients will be staged according to the 6th edition AJCC staging system with pathologic stage T1-3, N0-1, M-0 being eligible. Pathologic reporting using the CAPS format is strongly encouraged
.
.
Conditions for Patient Ineligibility
• Patients with non-adenocarcinomas, adenosquamous carcinomas, islet cell (neuroendocrine) tumors, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct, and ampullary carcinomas.
• Patients managed with a total pancreatectomy, a distal pancreatectomy, or central pancreatectomy.
• Prior systemic chemotherapy for pancreas cancer; note that Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

It is mandatory that the treating physician determine radiation therapy technique (3D-CRT or IMRT) that will be used prior to re-registering the patient.
XRT treatment plan to be submitted for review no sooner than 7 days and no later than 14 to 21 days after second randomization AND completion of first chemotherapy cycle of ARM 4
RT treatment plan must be APPROVED prior to XRT start.
Treatment:  Stratification by nodal status, CA-19, Surgical margins

First Randomization
Arm 1 - Gemcitabine x 5 cycles
Arm 2- Gemcitabine + Erlotinib x 5 cycles

Evaluate to Confirm No Progression

Second Randomization
Arm 3 - 1cycle of chemotherapy identical to the chemotherapy in Arm 1 and 2
Arm 4 - 1 cycle of chemotherapy identical to the chemotherapy in Arm 1 and 2 followed by XRT with either capecitabine or 5-FU
 

A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma (RTOG-1010)

Cancer Types:  Esophagus
Member Institutions:  Aria Health, Northeast Radiation Oncology Center, Sparta Cancer Treatment Center

Purpose:  To determine if trastuzumab increases disease-free survival when combined with Trimodality treatment (radiation plus chemotherapy followed by surgery) for patients with HER2-overexpressing esophageal adenocarcinoma
Eligibillity:  - Patient has a histologically confirmed primary adenocarcinoma of the esophagus that involves the mid (up to 25 cm), distal, or esophagogastric junction
- HER2-overexpressed
- Zubrod performance status 0-2
- No prior chemotherapy or radiation treatment for esophageal cancer
Treatment:  Arm 1: Radiation (50.4Gy), paclitaxel, carboplatin and trastuzumab. Following surgery maintenance trastuzumab, q 3 weeks for 13 treatments

Arm 2: Radiation (50.4Gy), paclitaxel, carboplatin. Surgery. Observation
 

A Phase III Trial of 6 versus 12 Treatments of Adjuvant FOLFOX plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer (CALGB-80702)

Cancer Types:  Colon
Member Institutions:  Ephrata Hospital, Sparta Cancer Treatment Center

Purpose:  To compare disease-free survival of patients with stage III colon cancer randomized to standard chemotherapy only (FOLFOX) or standard chemotherapy (FOLFOX) with 3 years of celecoxib 400 mg daily.
Eligibillity:  INCLUSION CRITERIA:
1) Patients must have histologically documented adenocarcinoma of the colon
2) Patients must not have rectal cancer
3) Patients must have had complete resection of the tumors; if tumor is adherent to adjacent structures, en bloc R0 resection must be documented
4) Patients must have node positive disease (N1 or N2). They must have at least one pathologically confirmed positive lymph node or N1C. They must not have resected stage IV disease.
5) Patients must not have any evidence of residual involved lymph node disease or metastatic disease at the time of registration.
6) Patients must not use NSAIDs at any dose or aspirin at > 325 mg more than 2 times per week on average (low dose aspirin, &#8804; 100 mg/day is permitted).
Treatment:  Arm A: 12 cycles of FOLFOX + Placebo daily
Arm B: 12 cycles of FOLFOX + Celecoxib daily
Arm C: 6 cycles of FOLFOX + Placebo daily
Arm D: 6 cycles of FOLFOX + Celecoxib daily
Celecoxib/placebo will continue for 3 years or until unacceptable toxicity
 

A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation plus Concurrent Boost Versus Standard Whole Breast Irradiation plus Sequential Boost for Early-Stage Breast Cancer (RTOG-1005)

Cancer Types:  Breast - Female
Member Institutions:  Hudson Valley Oncology Associates, Mercy Fitzgerald Hospital, Mercy Suburban Hospital, Northeast Radiation Oncology Center, Pocono Medical Center, Riddle Hospital, Sparta Cancer Treatment Center

Purpose:  Primary: - To determine whether an accelerated course of hypofractionated whole breast irradiation (WBI) including a concomitant boost to the tumor bed in 15 fractions following lumpectomy will prove to be non-inferior in local control to a regimen of standard WBI with a sequential boost following lumpectomy for early-stage breast cancer patients Secondary: - To determine whether breast-related symptoms and cosmesis from accelerated WBI that is hypofractionated (in only 3 weeks) with a concomitant boost is non-inferior to standard WBI with sequential boost - To determine whether the risk of late cardiac toxicity in patients with left-sided breast cancer treated with hypofractionation will be non-inferior conventional fractionated RT based upon analysis of radiation dosimetry from CT-based treatment planning and NTCP calculations - To determine whether CT-based conformal methods IMRT and 3DCRT for WBI are feasible in a multi-institutional setting following lumpectomy in early-stage breast cancer patients and whether dose-volume analyses can be established to assess treatment adequacy and likelihood of toxicity - To determine that cosmetic results and breast-related symptoms 3 years after hypofractionated breast radiation with concomitant boost will not be inferior to that obtained 3 years after whole breast irradiation with sequential boost - To determine whether future correlative studies can identify individual gene expressions and biological host factors associated with toxicity and/or local recurrence from standard and hypofractionated WBI - If shown to be non-inferior, to then determine if accelerated course of hypofractionated WBI including a concomitant boost to the tumor bed in 15 fractions following lumpectomy will prove to be superior in local control to a regimen of standard WBI with a sequential boost following lumpectomy for early-stage breast cancer patients - To determine whether treatment costs for hypofractionated WBI with concomitant boost are not higher than that for WBI with sequential boost
Eligibillity:  Eligibility Criteria
- Pathologically proven diagnosis of breast cancer resected by lumpectomy and whole breast irradiation with boost without regional nodal irradiation planned
- The patient must be female
- pStage I, II Breast Cancer AND at least one of the following
- Age < 50 years
- Positive axillary nodes
- Lymphovascular space invasion
- More than 2 close resection margins (> 0 mm to <= 2 mm)
- 1 close resection margin and extensive in-situ component (EIC)
- Focally positive resection margins
- Non-hormone sensitive breast cancer (ER and PR-negative)
- Grade III histology
- Oncotype recurrence score > 25
- pStage 0 breast cancer with nuclear grade 3 DCIS and patient age <50 years
- ypStage 0, I, II breast cancer resected by lumpectomy after neoadjuvant systemic therapy
- Study entry must be within 42 days of last breast/axillary surgery and/or last chemotherapy
- If multifocal breast cancer, then it must have been resected through a single lumpectomy incision with negative margins
- Breast-conserving surgery with margins defined as follows: (also see 3.1.3 for eligibility)
- Negative margins defined as no tumor at the resected specimen edge.
- Close resection margins > 0 mm to <=2 mm, as follows: One close resection margin and EIC; 2 or more close resection margins
- A focally positive resection margin
- Allowable options for mandatory axillary staging include:
- Sentinel node biopsy alone [If sentinel node is negative, pN0, pN0(IHC-,+)]
- Sentinel node biopsy alone, or followed by axillary node dissection, for clinically node negative patients as described below:
- microscopic sentinel nodes positive (pN1mic)
- one or two sentinel nodes positive (pN1) without extracapsular extension AND pT1 or pT2 AND no lymphovascular invasion AND at least one additional negative SN
- Sentinel node biopsy followed by axillary dissection with a minimum total of 6 axillary nodes if any of the following exist:
- for > 2 positive SN
- solitary SN that is positive without other sentinel nodes dissected
- for clinically (by either imaging or examination) T3 disease
- for the presence of one or more positive SNs with extracapsular extension, clinically node-positive disease, or LV1 in the primary tumor
- Axillary dissection alone (with a minimum of 6 axillary nodes)
- Age >= 18
- CT-imaging of the ipsilateral breast within 28 days of study entry for the radiation treatment planning. Must be able to delineate on CT scan the extent of the target lumpectomy cavity for boost (Placement of surgical clips to assist in treatment planning
of the boost is strongly recommended, see Section 6.4.2.1a for details)
- Appropriate stage for protocol entry, including no clinical evidence for distant metastases, based upon the following minimum diagnostic workup:
- History/physical examination, including breast exam and documentation of weight and Zubrod Performance Status of 0-2 within 28 days prior to study entry
- Bilateral mammogram within 6 months prior to study entry
- CBC/differential obtained within 14 days prior to study entry, with adequate bone marrow function defined as follows:
- Absolute neutrophil count (ANC) >= 1800 cells/mm3
- Platelets >= 75,000 cells/mm3
- Hemoglobin >= 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb >= 8.0 g/dl is acceptable)
- Women of childbearing potential must be non-pregnant and non-lactating and willing to use a medically acceptable form of contraception during radiation therapy
- Patient must provide study specific informed consent prior to study entry

Ineligibility Criteria
- AJCC pathologic T4, N2 or N3, or M1 breast cancer
- Treatment plan that includes regional node irradiation
- Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to registration
- Prior invasive or in-situ carcinoma of the breast (prior LCIS is eligible)
- Two or more breast cancers not resectable through a single lumpectomy incision
- DCIS and age >= 50 years
- DCIS and age < 50 years and nuclear grade 1 or 2
- Invasive breast cancer and low risk (see low risk features below) for 5-year in breast recurrence after lumpectomy with negative margins (UNLESS meeting one of the eligibility factors in 3.1.3) defined as:
- >= 70 years old, T1, N0, ER/PR positive
- > 50 years old, T1, N0, Grade 1-2 breast cancer, ER/PR positive
- Unable to delineate on CT scan the extent of the target lumpectomy cavity for boost (Placement of surgical clips to assist in treatment planning of the boost is strongly recommended, see Section 6.4.2.1a for details)
- Suspicious unresected microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign
- Non-epithelial breast malignancies such as sarcoma or lymphoma
- Paget's disease of the nipple
- Male breast cancer
- Prior radiotherapy to the breast or prior radiation to the region of the ipsilateral breast
that would result in overlap of radiation therapy fields
- Intention to administer concurrent chemotherapy for current breast cancer
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction withinthe last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive
- Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
- Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
- Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent
Treatment:  Arm 1: Standard fractionation
- Whole breast 50.0 Gy/25 fractions/2.0 Gy daily
- Optional fractionation of 42.7 Gy in 16 fractions permissible
- Sequential Boost 12 Gy/6 fractions/2.0 Gy daily OR 14.0 Gy/7 fractions/2 Gy daily

Arm 2: Hypofractionation (15 fractions total)
- Whole Breast 40 Gy/15 fractions/2.67 Gy daily
- Concurrent boost 48.0 Gy/3.2 Gy daily
 

A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared with Whole Brain Radiotherapy (WBRT) for Resected Metastaic Brain Disease (RTOG-1270/NCCTG-N107C)

Cancer Types:  Brain & Nervous System
Member Institutions:  Aria Health

Purpose:  1) To determine in patients with one to four brain metastases whether there is improved overall survival in patients who receive SRS to the surgical bed compared to patients who receive WBRT. 2) To determine in patients with one to four brain metastases whether there is less neurocognitive progression at 6 months post-randomization in patients who receive SRS to the surgical bed compared to patients who receive WBRT.
Eligibillity:  DISEASE CHARACTERISTICS:
1) Four or fewer brain metastases (as defined on the pre-operative MRI brain scan) and status post resection of one of the lesions
2) Pathology from the resected brain metastasis must be consistent with a non-central nervous system primary site
a) Patients with or without active disease outside the nervous system are eligible (including patients with unknown primaries), as long as the pathology from the brain is consistent with a non-central nervous system primary site
3) Any unresected lesions must measure &#8804; 3.0 cm in maximal extent on the contrasted MRI brain scan obtained &#8804; 35 days prior to pre-registration
a) The metastases size restriction does not apply to the resected brain metastasis; with resected brain metastases only surgical cavity size determines eligibility
4) Planning MRI confirmed zero, one, two or three unresected lesions
a) Each unresected lesion must measure < 3.0 cm in maximal extent on the contrasted planning MRI brain scan
b) The pre-registration brain scan may be used for the planning scan if obtained &#8804; 14 days prior to randomization
5) Resection cavity must measure < 5.0 cm in maximal extent on the post-operative MRI (or CT) brain scan obtained &#8804; 35 days prior to pre-registration
a) The pre-registration brain scan may be used for the planning scan if obtained &#8804;14 days prior to randomization
b) It is permissible for the resection of a dominant brain metastasis to include a smaller "satellite" metastasis as long as the single resection cavity is less than the maximum size requirements
6) All standard tumor-staging procedures necessary to define baseline extracranial disease status completed &#8804; 42 days prior to pre-registration
7) No primary germ cell tumor, small cell carcinoma, or lymphoma
8) No widespread definitive leptomeningeal metastasis
9) No brain metastasis that is located &#8804; 5 mm of the optic chiasm or within the brainstem

PATIENT CHARACTERISTICS:
1) ECOG performance status (PS) 0, 1, or 2
2) Ability to be treated with either a gamma knife or a linear accelerator-based radiosurgery system
3) Willing and able to complete neurocognitive examination without assistance
4) Willing and able to complete quality-of-life (QOL) questionnaires by themselves or with assistance
5) Willing to provide mandatory blood and urine samples for correlative research purposes
6) None of the following:
a) Pregnant or nursing
b) Men or women of childbearing potential who are unwilling to employ adequate contraception through out the study and for men for up to 3 months after completing treatment
7) Able to complete a MRI with contrast of the head
8) No known allergy to gadolinium

PRIOR CONCURRENT THERAPY:
1) No prior cranial radiotherapy
2) No planned cytotoxic chemotherapy during the stereotactic radiosurgery (SRS) or whole-brain radiotherapy (WBRT)
3) Concurrent hormonal agents, steroids, and/or anticonvulsants allowed
Treatment:  Arm A: WBRT 3750cGy in 15 Fractions
Arm B: SRS to surgical bed 12-20 Gy in single Fraction
 

A Phase III Trial of Short Term Androgen Deprivation with Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients with a Rising PSA After Radical Prostatectomy (RTOG-0534)

Cancer Types:  Prostate
Member Institutions:  Aria Health, Hudson Valley Oncology Associates, Northeast Radiation Oncology Center, Sparta Cancer Treatment Center, Upper Delaware Valley Cancer Center

Purpose:  Objectives: 1) To determine whether the addition of NC-STAD to PBRT improves freedom from progression (FFP) for 5 years, over that of PBRT alone in men treated with salvage RT after radical prostatectomy 2) To determine whether NC-STAD+PLNRT+PBRT improves FFP over that of NC-STAD+PBRT and PBRT alone in men treated with salvage RT after radical prostatectomy.
Eligibillity:  Lymph node negative adenocarcinoma of the prostate treated with radical prostatectomy
PSA of &#8805; 0.2 - < 2.0 ng/mL
Pathologic T3N0/Nx disease or pathologic T2N0/Nx disease, if the prostatectomy margin is positive or prostatic fossa or urethral-vesical anastomosis biopsies are positive
Treatment:  Arm 1: PBRT Alone, PBRT 64.8-70.2 Gy
Arm 2: PBRT + NC-STAD, PBRT 64.8-70.2 Gy + NC-STAD for 4-6 months, beginning 2 months before RT
Arm 3: PLNRT + PBRT + NC-STAD, PLNRT to 45 Gy and PBRT to 64.8-70.2 Gy, NC-STAD for 4-6 months,beginning 2 months before RT
 

A Phase II Randomized Study of Whole Brain Radiotherapy in Combination with Concurrent Lapatinib in Patients with Brain Metastasis from HER2&#8208;Positive Breast Cancer: A Collaborative Study of RTOG and KROG (RTOG-1119)

Cancer Types:  Breast - Female
Member Institutions:  Northeast Radiation Oncology Center, Sparta Cancer Treatment Center

Purpose:  PRIMARY OBJECTIVE: 1) To determine if there is a signal for an increase in complete response (CR) rate in the brain at 12 weeks post WBRT as determined by MRI scan of the brain, with the addition of lapatinib to WBRT compared to WBRT alone. SECONDARY OBJECTIVES: 1) To evaluate CR rate in the brain at 4 weeks post WBRT as determined by MRI scan of the brain, with the addition of lapatinib to WBRT compared to WBRT alone. 2) To evaluate objective response rate in the brain at 4 and 12 weeks post WBRT as determined by MRI scan of the brain, with the addition of lapatinib to WBRT compared to WBRT alone. 3) To evaluate lesion&#8208;specific objective response rate (CR + PR) at 4 and 12 weeks post WBRT. 4) To evaluate overall response with addition of lapatinib to WBRT compared to WBRT alone. 5) To evaluate the CNS progression&#8208;free survival (CNS PFS) rate and overall survival (OS) rate, with the addition of lapatinib to WBRT compared to WBRT alone. 6) To evaluate treatment related adverse events when adding lapatinib to WBRT compared to WBRT alone.
Eligibillity:  INCLUSION CRITERIA:
1) Pathologically (histologically or cytologically) proven diagnosis of invasive breast cancer
2) Human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer (3+ staining by immunohistochemistry or HER2 gene amplification by fluorescent in situ hybridization [FISH] or silver in situ hybridization [SISH] &#8805; 2.2)
3) Brain metastases that fulfill 1 of the following:
a) Progressive parenchymal brain metastases following stereotactic radiosurgery for 1-3 brain metastases, with at least 1 new measurable lesion
b) Progressive parenchymal brain metastases following surgical resection of 1-3 brain metastases, as long as at least 1 brain metastasis is measurable
4) At least 1 measurable, unirradiated parenchymal brain lesion (&#8805; 10 mm on T1-weighted gadolinium-enhanced MRI) within 21 days prior to study entry
5) No leptomeningeal disease
6) Karnofsky performance status &#8805; 60%
7) Able to swallow and retain oral medication (Note: for patients unable to swallow tablets, an oral suspension preparation is acceptable)
8) Absolute neutrophil count (ANC) &#8805; 1,200 cells/mm³
9) Platelets &#8805; 70,000 cells/mm³
10) Hemoglobin [Hgb] &#8805; 8.0 g/dL (Note: The use of transfusion or other intervention to achieve Hgb &#8805; 8.0 g/dL is acceptable)
11) Creatinine < 1.5 times institutional upper limit of normal (ULN)
12) Bilirubin < 1.5 times institutional ULN
13) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) &#8804; 3.0 times institutional ULN with or without liver metastasis
14) Women of childbearing potential must have a negative serum pregnancy test within 21 days prior to study entry
15) Sexually active women of childbearing potential and sexually active men must practice adequate contraception during therapy and for 12 months after protocol treatment completion
16) Women should not breastfeed while on this study
17) No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
18) No prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
19) No severe, active co-morbidity, defined as follows:
a) Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
b) Transmural myocardial infarction within the last 6 months
c) Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study entry
d) Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry
e) Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; hepatic or biliary disease that is acute or currently active or that requires antiviral therapy (with the exception of patients with Gilbert syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment)
f) History of left ventricular ejection fraction (LVEF) below institutional normal unless repeated and within institutional normal range within 90 days of study entry
20) No grade 2 or greater rash of any cause at time of study entry
21) No grade 2 or greater diarrhea of any cause at time of study entry
22) At least 14 days between FINAL dose of prior chemotherapy and study entry, with recovery of toxicities to grade 0 or 1
23) No prior whole-brain radiation therapy (WBRT)
24) No prior lapatinib therapy
25) No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields except patients who have progressed following stereotactic radiosurgery for 1-3 brain metastases, with at least one new lesion
26) No concurrent intensity-modulated radiation therapy
Treatment:  Arm A: WBRT 37.5 Gy in 15 fractions for 3 weeks

Arm B: WBRT 37.5 Gy in 15 fractions for 3 weeks Plus Lapatinib: Once daily starting up to 1 day before the first day of WBRT and continuing until 21 days after the final day of WBRT
 

A Prospective Phase II Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy (RTOG-0526)

Cancer Types:  Prostate
Member Institutions:  Albert Einstein Medical Center, Hudson Valley Oncology Associates, Northeast Radiation Oncology Center, Pocono Medical Center

Purpose:  To study how effective and safe prostate seed implants are for recurrent prostate cancer
Eligibillity:  - Documented biopsy for locally recurrent prostatic adenocarcinoma 30 months after the completion of EBRT, biopsied &#8804; 180 days prior to registration.
-Disease-related characteristics at initial diagnosis (i.e., prior to EBRT) must fit one of the following categories Stages T1-T2c, Gleason scores 2-6, and PSA &#8804; 20 ng/mL, or
&#56256;&#56451; Stages T1-T2c, Gleason score 7, and PSA &#8804; 10 ng/mL
- History/physical with digital rectal examination of the prostate within 8 weeks prior to registration
- Negative lymph nodes by imaging (pelvic ± abdominal CT or MR), or by nodal dissection (laparoscopy or laparotomy) within 8 weeks prior to registration.
- No evidence of bone metastases (M0) on bone scan within 8 weeks prior to registration.
- Zubrod Performance Status (0-6).
- (< 15) American Urological Association Symptom Index Score (AUA BPH).
- &#8805; 18 years old
- Baseline serum PSA value < 10 ng/mL performed with an FDA approved assay (e.g., Abbott, Hybritech) within 8 weeks prior to registration or 8 weeks prior to start of hormonal therapy and not within 10 days of a prior prostate biopsy.
-Prostate volume as measured by transrectal ultrasound (TRUS) &#8804; 45 cc.
- Patient is suitable for spinal or general anesthesia.
- The patient has not had prior invasive cancer (except non-melanoma skin cancer) or hematological (e.g., acute leukemia, aggressive lymphoma, myeloma) malignancy within the past 3 years (Previous diagnosis of lowgrade lymphoma or chronic lymphocytic leukemia is allowed.
- The patient has not had prior EBRT to the prostate that exceeded 72 Gy (2 Gy fractions) or 75.6 Gy (1.8 Gy fractions).
- The patient does not have gastrointestinal (GI) or genitourinary (GU) toxicity at the time of registration (for any reason) grade &#8805; 2 as defined in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
-The patient does not have any of the following severe, active comorbidities
&#56256;&#56451; Unstable angina and/or decompensated congestive heart failure
&#56256;&#56451; Myocardial infarction within the last 6 months
&#56256;&#56451; Bacterial or fungal infection requiring intravenous antibiotics at the time of registration
&#56256;&#56451; Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
&#56256;&#56451; Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
&#56256;&#56451; Acquired immune deficiency syndrome (AIDS) based upon current CDC definition
-The patient does not have clinical and/or radiologic evidence of extraprostatic disease at initial diagnosis (i.e., prior to EBRT) or at time of local recurrence (i.e., prior to study registration)
The patient has not had any of the following prior therapies
&#56256;&#56451; Transurethral resection of the prostate (TURP)
&#56256;&#56451; Radionuclide (permanent or temporary implantation) prostate brachytherapy
&#56256;&#56451; Prostatectomy or prostatic cryosurgery
&#56256;&#56451; HIFU (high-intensity focused ultrasound)
&#56256;&#56451; Bilateral orchiectomy
&#56256;&#56451; Chemotherapy for prostatic carcinoma
The patient did not start an LHRH agonist less than 2 months or more than 6 months before registration.
- There was no androgen suppression therapy (neoadjuvant, concurrent, or adjuvant) at the time of initial diagnosis and the initial external RT with a duration of > 8 months.
Treatment:  * 125-iodine (I-125) 140 Gy minimum target dose or;
* 103-palladium (Pd-103) 120 Gy minimum target dose
 

A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) (SWOG-S0819)

Cancer Types:  Lung
Member Institutions:  Associates in Hematology-Oncology, PC, Ephrata Hospital, Hematology & Oncology Associates of NE PA, Mercy Philadelphia, Mercy Suburban Hospital, Riddle Hospital

Purpose:  In patients with advanced NSCLC treated with carboplatin, paclitaxel and bevacizumab (if appropriate) with or without cetuximab, to compare: a. Overall survival (OS) in the entire study population b. Progression-free survival (PFS) by institutional review in EGFR FISH-positive patients
Eligibillity:  -Patients must have histologically or cytologically proven newly diagnosed Stage IV
-Patients with controlled (for a minimum of 2 months) brain metastases after treatment,
and no residual neurological dysfunction off corticosteroids are eligible.
-Patients must not have received for any purpose prior chemotherapy, cetuximab,gefitinib, erlotinib or other investigational agents that target the EGFR pathway
-Prior radiation is permitted; however, patients must have recovered from all associated toxicities at time of registration.
Treatment:  Carboplatin/Paclitaxel or
Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab
 

A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel Vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma (GOG-0258)

Cancer Types:  Corpus Uteri
Member Institutions:  Hematology & Oncology Associates of NE PA, Sparta Cancer Treatment Center

Purpose:  To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of recurrence or death (i.e. increases recurrence-free survival) when compared to chemotherapy consisting of carboplatin and paclitaxel for 6 cycles (control arm) in patients with Stages III-IVA endometrial carcinoma (<2 cm residual disease).
Eligibillity:  Inclusion:
All patients with FIGO Surgical Stage III or IVA endometrial carcinoma, including clear cell and serous papillary and undifferentiated carcinomas.

Surgical Stage III disease includes those patients with positive adnexa, tumor invading the serosa, positive pelvic and/or para-aortic nodes, or vaginal involvement. Patients with positive pelvic washings as the only extra-uterine disease are eligible only if the histology is clear cell or serous papillary.

Surgical Stage IVA includes patients with bladder or bowel mucosal involvement, but no spread outside the pelvis.

Surgery must have included a hysterectomy and bilateral salpingo-oophorectomy. Pelvic lymph node sampling and para-aortic lymph node sampling are optional.

Patients with a GOG Performance Status of 0, 1, or 2.

Patients with adequate organ function.

Exclusion:
Patients with carcinosarcoma .

Patients with recurrent endometrial cancer.

Patients with residual tumor after surgery (any single site) exceeding 2 cm in maximum dimension.

Patients who have had pelvic or abdominal radiation therapy. 8 GOG-0258

Patients with positive pelvic washings as the only extra-uterine disease are NOT
eligible if the histology is other than clear cell or papillary serous carcincoma..

Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of active malignancy within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.

Patients with a history of serious co-morbid illness or uncontrolled illnesses that would preclude protocol therapy.

Patients with an estimated survival of less than three months.

Patients with Stage IVB endometrial cancer.

Patients with parenchymal liver metastases.

Patients who have received prior chemotherapy for endometrial cancer.

Patients with a history of myocardial infarction, unstable angina, or uncontrolled arrhythmia within 3 months from enrollment.
Treatment:  REGIMEN I:
Cisplatin 50 mg/m2 IV Days 1 and 28
plus Volume-directed radiation therapy followed by
Carboplatin AUC 5* plus Paclitaxel 175 mg/m2 q 21 days for
4 cycles with G-CSF support
or
REGIMEN II: Carboplatin AUC 6 plus
Paclitaxel 175 mg/m2 q 21 days for 6 cycles
 

A Randomized Phase III Trial of the Value of the Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer (ECOG-E2108)

Cancer Types:  Breast - Female, Breast - Male
Member Institutions:  Associates in Hematology-Oncology, PC, Mercy Suburban Hospital, Sparta Cancer Treatment Center

Purpose:  The primary study objective is to determine if early local treatment of the affected breast provides a survival advantage in women with metastatic breast cancer. Secondary objectives include determining differences in quality of life, differences in time to uncontrolled chest wall disease, and difference in tumor burden of circulating tumor cells at 6 months between the two groups.
Eligibillity:  Inclusion Criteria:
- Patients must have intact primary invasive breast cancer.
- Patients should have at least one site of metastatic disease. If only one site, biopsy must be performed.
- Radiology reports done within 4 weeks prior to start of systemic therapy must document status of disease.
- Patients must have completed at least 16 weeks of systemic therapy (with no more than 2 weeks of dose interruption), and must not have experienced disease progression since the start of treatment.
- Local disease at primary site must be asymptomatic and patients must be judged candidates for complete resection with negative margins followed by radiation therapy
- Patients must have adequate organ function.

Exclusion criteria:
- Pregnant or breastfeeding women
Treatment:  Metastatic breast cancer patients with intact primary tumor:

Patients are started on optimal systemic therapy as determined by the medical oncologist. Within 20 weeks of initiation of systemic therapy, if patients have not progressed on systemic therapy, they are randomized to either continue systemic therapy or to undergo early local therapy (surgery to remove breast tumor(s) with clear margins, followed radiation therapy) and then to continue on systemic therapy.
 

A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors (RTOG-1008)

Cancer Types:  Lip, Oral Cavity, and Pharynx
Member Institutions:  Sparta Cancer Treatment Center

Purpose:  Primary Objectives: - Determine the feasibility of conducting a cooperative group prospective clinical trial in patients with resected malignant salivary gland tumors - Acquire preliminary efficacy data comparing postoperative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin Secondary Objectives: - Compare the acute toxicities of these 2 adjuvant treatments - Compare long-term efficacy results at 5 years and late treatment-related adverse events in patients receiving postoperative radiation to those receiving concurrent chemoradiation - Investigate quality of life and patient-reported outcomes in patients enrolled in the study - Identify the histopathology and tumor marker expression from patients enrolled on this trial and assemble a tissue bank for future correlative studies - Establish an RTOG baseline database for salivary gland malignancies to serve as a resource for future exploration of innovative and/or targeted approaches for this disease
Eligibillity:  Conditions for Patient Eligibility
- Pathologically proven diagnosis of a malignant major salivary gland tumor of the following histologic subtypes: high grade mucoepidermoid carcinoma, salivary duct carcinoma, or high grade adenocarcinoma
- Surgical resection with curative intent within 8 weeks prior to registration
- Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (<=1mm) or microscopically positive surgical margin; patients must be free of distant metastases based on the following minimum diagnostic workup: History/physical examination within 8 weeks prior to registration, Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to registration; at a minimum, contrast CT imaging of the chest is required; PET/CT is acceptable
- Zubrod 0-1
- Age >=18
- CBC/diff obtained within 4 weeks prior to reg., with adequate bone marrow function defined as follows: ANC >= 1800 cells/mm3, Platelets >= 100,000 cells/mm3, Hgb >= 8.0 g/dl (transfusion OK)
- Adequate renal and hepatic function within 4 weeks prior to registration, defined as follows: Serum creatinine < 2.0 mg/dl, Total bilirubin < 2 x ULN, AST or ALT < 3 x ULN
- Negative serum pregnancy test within 2 weeks prior to registration for WCBP
- WCBP and male participants who are sexually active must practice adequate contraception during tx and 6 weeks following tx
- Patients must be deemed able to comply with the treatment plan and follow-up schedule
- Patients must provide study-specific informed consent prior to study entry, including consent for mandatory tissue submission for central review
Conditions for Patient Ineligibility
- Patients with residual macroscopic disease after surgery
- Patients with salivary gland malignancies originating from the minor salivary glands
- Patients with histologies other than high grade mucoepidermoid carcinoma, high grade adenocarcinoma or salivary duct carcinoma
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
- Prior systemic chemotherapy or radiation therapy for salivary gland malignancy; note that prior chemotherapy for a different cancer is allowable
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Severe, active co-morbidity, defined as follows: Unstable angina and/or CHF requiring hospitalization within the last 6 months; Transmural myocardial infarction within the last 6 months; Acute bacterial or fungal infection requiring IV antibiotics at time of reg.; COPD or other respiratory illness requiring hospitalization or precluding study therapy at time of reg.; Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that coagulation parameters are not required for entry into this protocol; AIDS; Pre-existing >= grade 2 neuropathy; Prior organ transplant
- Pregnancy or WCBP and men who are sexually active and not willing to use contraception
- Significant pre-existing hearing loss, as defined by the patient or treating physician
Treatment:  Stratify based on histology and nodal status:
1. High-grade mucoepidermoid carcinoma/Salivary duct carcinoma/High-grade adenocarcinoma
2. N0/N1-3

Randomize
1. Arm 1: Radiation 60-66 Gy in 2 Gy daily fractions + Cisplatin 40 mg/m2 weekly during radiation for 7 doses
2. Arm 2: Radiation 60-66 Gy in 2 Gy daily fractions
 

A Randomized Phase II Trial Of Hypofractionated Radiotherapy For Favorable Risk Prostate Cancer (RTOG-0938)

Cancer Types:  Prostate
Member Institutions:  Northeast Radiation Oncology Center, Sparta Cancer Treatment Center

Purpose:  To demonstrate that 1-year health-related quality of life (HRQOL) for at least one hypofractionated arm is not significantly lower than baseline as measured by the Bowel and Urinary domains of the Expanded Prostate Cancer Index Composite (EPIC) instrument.
Eligibillity:  1. Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days of randomization
2. Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason scores 2-6 within 180 days of randomization
3. Clinical stage T1-2a (AJCC 7th edition) within 90 days of randomization
4. PSA < 10 ng/mL within 60 days prior to registration. PSA should not be obtained within 10 days after prostate biopsy.
5. Zubrod Performance Status 0-1 within 60 days prior to registration
6. No prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years.
7. No evidence of distant metastases
8. No regional lymph node involvement
9. No previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer
10. No previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
11. No previous hormonal therapy, such as LHRH agonists or LHRH antagonists, anti-androgens, estrogens, or surgical castration (orchiectomy). Can wash out of 5&#945; reductase inhibitors.
Treatment:  In Arm 1 of the study patients will receive 5 fractions of radiation; each fraction size will be 7.25 Gy. The total dose will be 36.25 Gy. The 5 treatments will be scheduled to be delivered twice a week over approximately 15-17 days. A minimum of 72 hours and a maximum of 96 hours should separate each treatment. No more than 2 fractions will be delivered per week. The total duration of treatment will be no shorter than 15 days and no longer than 17 days.

In Arm 2 of the study patients will receive 12 daily fractions of 4.3 Gy. These patients will be treated 5 days a week. The total dose will be 51.6 Gy. The total duration of treatment will be no shorter than 16 days and no longer than 18 days
 

(CIRB) A Phase III Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less (SWOG-S1007)

Cancer Types:  Breast - Female
Member Institutions:  Associates in Hematology-Oncology, PC, Ephrata Hospital, Hematology & Oncology Associates of NE PA, Mercy Suburban Hospital, Riddle Hospital, Sparta Cancer Treatment Center

Purpose:  To determine the effect of chemotherapy in patients with node positive breast cancer who do not have high Recurrence Scores (RS) by Oncotype DX®. In patients with 1-3 positive nodes, and hormone receptor (HR)-positive, HER2-negative breast cancer with RS &#8804; 25 treated with endocrine therapy we will test whether the difference in disease-free survival for patients treated with chemotherapy compared to no chemotherapy depends directly on the magnitude of RS. If benefit depends on the RS score, the trial will determine the optimal cutpoint for recommending chemotherapy or not.
Eligibillity:  • Patients must have a histologically confirmed diagnosis of node positive (1-3 nodes) invasive breast carcinoma with positive estrogen and/or progesterone receptor status, and negative HER-2, as determined by IHC or non-amplified FISH for screening.
• Patients will have undergone axillary staging by sentinel node biopsy or axillary lymph node dissection (ALND).
• Patients must not have inflammatory breast cancer and must not have metastatic disease.
• Patients must have had either breast-conserving surgery with planned radiation therapy or total mastectomy
• Registration of patients who have not yet undergone Oncotype DX® screening must occur no sooner than 28 days and no later than 56 days after definitive surgery.
• Patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to registration.
• Patients must not have received preventive tamoxifen or raloxifene, or have received prior therapeutic breast radiation.
Treatment:  Arm 1 (chemotherapy and endocrine therapy): All Arm 1 patients will receive a protocol-approved chemotherapy regimen, followed by a protocol-approved endocrine therapy. Choice of chemotherapy will depend on patient/physician preference. Choice of therapy will depend on menopausal status (see below) and patient/physician preference.
Arm 2 (endocrine therapy alone): Patients will receive a protocol-approved endocrine therapy. Choice of therapy will depend on menopausal status (see above) and patient/physician preference.
 

(CIRB) A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer (NSABP B-47)

Cancer Types:  Breast - Female
Member Institutions:  Associates in Hematology-Oncology, PC, Ephrata Hospital, Hematology & Oncology Associates of NE PA, Mercy Fitzgerald Hospital, Mercy Suburban Hospital, Pocono Medical Center, Riddle Hospital, Sparta Cancer Treatment Center

Purpose:  To determine whether the addition of trastuzumab to chemotherapy (TC or AC followed by WP) improves invasive disease-free survival (IDFS), disease-free survival and DCIS in women with resected node-positive or high-risk node-negative breast cancer which is reported as HER2-low by all HER2 testing performed.
Eligibillity:  ECOG PS 0-1; unilateral invasive adenocarcinoma of the breast; node-pos. or high-risk node-neg neg.; primary tumor must be HER2 1+ or 2+; nodes evaluated via SN or AD; tumor resected with neg. margins; randomization within 84 days of definitive surgery; submission of tumor samples required
Treatment:  Physician choice of chemotherapy ( docetaxel & cyclophosphamide q 3 wks. x 6 cycles vs doxorubicin & cyclophosphamide q 3 wks x 4 cycles, then weekly paclitaxel x 12 wks.) with vs without trastuzumab given q 3 wks. x 1 yr.
 

Phase II Randomized Trial of Prophylactic Manuka Honey for the Reduction of Chemoradiation Therapy Induced Esophagitis-Related Pain During the Treatment of Lung Cancer (RTOG-1012)

Cancer Types:  Lung
Member Institutions:  Aria Health, Northeast Radiation Oncology Center, Pocono Medical Center, Sparta Cancer Treatment Center, Upper Delaware Valley Cancer Center

Purpose:  Evaluate the relative efficacy of 4 times a day consumption of liquid or lozenge Manuka honey to delay or prevent radiation esophagitis-related pain (during combined chemotherapy and radiation therapy for lung cancer) as compared to standard supportive treatment, as measured at week 4 by Numerical Rating Pain Scale (NRPS) for pain upon swallowing.
Eligibillity:  Patients being treated with combination chemotherapy (definitive or adjuvant) and radiation therapy once daily for small cell or non-small cell lung cancer [primary population for the trial];
Note: Patients can receive chemoradiotherapy while enrolled on an RTOG lung trial or while not enrolled on an RTOG lung trial. Patients cannot receive chemoradiotherapy while enrolled on a single institution trial or trials coordinated by other cooperative groups [to increase the homogeneity of the population].
- At least 5 cm of the esophagus must be in the 60 Gy isodose volume in 1.6 to 2.0 Gy fractions [to insure that there is a significant risk for esophagitis among the patients];
- Age &#8805; 18 [RTOG standard];
- Patients must provide study specific informed consent prior to study entry.
Treatment:  Group 1 (often called "Arm A") will receive standard supportive care for esophagitis-related pain (medications to mask pain) while patients are receiving radiation and chemotherapy.

Group 2 (often called "Arm B”) will receive liquid honey that may delay or prevent esophagitis related pain. Patients will slowly swallow 2 level teaspoons of honey to allow coating of the esophagus. Patients will swallow the honey 4 times a day

Group 3 (often called “Arm C”) will receive honey in tablet form (a lozenge) that may delay or prevent esophagitis-related pain. Patients will take the 2 tablets 4 a day.
 

Randomized Phase III Study of Maintenance Therapy with Bevacizumab, Pemetrexed or Both Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Stage Non-Squamous Non-Small Cell Lung Cancer (ECOG-E5508)

Cancer Types:  Lung
Member Institutions:  Ephrata Hospital, Hematology & Oncology Associates of NE PA, Mercy Fitzgerald Hospital, Riddle Hospital, Sparta Cancer Treatment Center

Purpose:  To compare the overall survival associated with maintenance therapy with bevacizumab, pemetrexed or the combination in patients with advanced stage NSCLC
Eligibillity:  • Cytological or histological confirmation of non-small cell lung cancer.
• Predominant non-squamous histology (patients with NSCLC NOS are eligible). Mixed tumors will be categorized by the predominant cell type. If small cell elements are present the patient is ineligible.
• Stage IV disease
• No prior systemic chemotherapy for advanced stage lung cancer.
• Prior use of paclitaxel, pemetrexed or bevacizumab is not allowed. Prior use of carboplatin is allowed if it was given as part of adjuvant chemotherapy.
Treatment:  Induction Therapy: 4 cycles of Paclitaxel, carboplatin and bevacizumab
Maintenance Therapy: Randomized to one of the following Arms:
1. Bevacizumab
2. Pemetrexed
3. Bevacizumab and Pemetrexed
 

Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC) (RTOG-0937)

Cancer Types:  Lung
Member Institutions:  Aria Health, Northeast Radiation Oncology Center, Sparta Cancer Treatment Center, Upper Delaware Valley Cancer Center

Purpose:  1) To determine the 1-year overall median survival rate in patients with ED-SCLC with the administration of PCI alone versus PCI with consolidation extracranial RT following platinumbased chemotherapy 2) To compare treatment-related adverse events
Eligibillity:  - Pathologically (histologically or cytologically) proven diagnosis of extensive disease small cell lung cancer without brain metastases and with 1-3 metastatic lesions within 6 months of registration; Note: This does NOT include patients initially diagnosed with LD-SCLC who have progressed.

-Patients must have completed 4-6 cycles of platinum-based chemotherapy.

-Prior to chemotherapy (at diagnosis), patients must have extensive stage disease with 1-3 extracranial metastatic lesions (no brain metastases). For example, the patient could have 2 lesions in the liver and 1 in the contralateral lung; or 1 in the bone, 1 in the contralateral lung, and 1 in the liver; or 3 liver lesions, etc. Lesion is not defined as “organ”.

-After chemotherapy, patients will be restaged using the same minimal diagnostic work up as required pre-chemotherapy (see Section 3.1.4). Patients must have:
• no CNS metastases;
• radiographic partial or complete response to chemotherapy in a minimum of 1 site of disease using RECIST criteria (see Section 11.3.2); Note: if radiation has been delivered to primary disease with chemotherapy, there must be complete or partial response in at least 1 of the sites that has not been treated with radiation.
• no progression in any site;
• for the purposes of stratification, a response to treatment is only considered a “CR” if the patient has had a complete response in all sites of measurable disease.

-Patients who have had thoracic radiation concurrently or prior to chemotherapy for the current diagnosis and meet all other eligibility criteria are eligible for the study but will not receive mediastinal radiation per protocol.

-Measurements for all post-chemotherapy measurable disease must be submitted.

-Zubrod Performance Status 0-2

-For patients who will be treated with radiation to the liver, adequate hepatic function, defined as follows:
*Serum ALT and AST within 2.5 X ULN within 1 week prior to registration;
*Serum bilirubin < 1.5 X ULN within 1 week prior to registration.
*For patients who will be treated with radiation to the kidneys, adequate renal function defined as a serum creatinine < 1.5 X ULN within 1 week of registration;
*CBC/differential obtained within 1 week prior to registration, with adequate bone marrow function defined as follows:
*Absolute neutrophil count (ANC) &#8805; 1,000 cells/mm3;
*Platelets &#8805; 75,000 cells/mm3

-Hemoglobin &#8805; 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb &#8805;8.0 g/dl is acceptable.).

-For women of childbearing potential, a negative serum pregnancy test within 1 week of registration.
-All toxicities related to chemotherapy must be resolved to < grade 1 prior to initiation of study therapy (with the exception of neuropathy and alopecia, which may take a longer period to recover). Laboratory abnormalities, with the exception of those specified in Sections 3.1.9,
3.1.10, and 3.1.11, are allowed if they are not deemed clinically significant.
Treatment:  Arm 1: Prophylactic Cranial Irradiation
2.5 Gy per fraction for a total of 25 Gy
Arm 2: Prophylactic Cranial Irradiation
2.5 Gy per fraction for a total of 25 Gy and Consolidative Radiation to Locoregional and Residual Metastatic Disease 45 Gy at 3 Gy per fraction*

*Acceptable alternative: 40 Gy at 4 Gy per fraction
 

Randomized Phase II Study of Pre-operative Chemoradiotherapy +/- Panitumumab followed by Consolidation Chemotherapy in Potentially Operable Locally Advanced (Stage IIIA, N2+) Non-Small Cell Lung Cancer (RTOG-0839)

Cancer Types:  Lung
Member Institutions:  Sparta Cancer Treatment Center

Purpose:  Mediastinal nodal clearance following completion of induction chemoradiation +/- panitumumab
Eligibillity:  -Pathologically proven diagnosis of Stage IIIA (T1-T3) [AJCC Staging, 7th edition; see Appendix III] with a single primary lung parenchymal lesion and ipsilateral positive mediastinal nodes within 12 weeks of registration

-Histologic proof of non-small cell histology (adenocarcinoma, adenosquamous, large cell carcinoma, squamous carcinoma, non-lobar and non-diffuse bronchoalveolar cell carcinoma or non-small cell lung cancer NOS) within 12 weeks of registration; note: mixed small cell and non-small cell histologies are not eligible for this study

-Positive ipsilateral mediastinal node or nodes (N2), with or without positive ipsilateral hilar nodes (N1); N2 nodes must be separate from primary tumor by either CT scan or surgical exploration, and the maximum nodal diameter not to exceed 3.0 cm.

- N2 status must be pathologically confirmed to be positive within 4 weeks prior to registration

-History/physical examination, including a neurological assessment, within 8 weeks of registration

-Evaluation by a thoracic surgeon within 4 weeks of registration; the patient must be deemed potentially operable and resectable to be eligible for the study.

-Adequate bone marrow function

-Adequate hepatic, renal, and pulmonary function
Treatment:  Arm 1: Induction Chemoradiation
Paclitaxel & Carboplatin: 1x/week for 6 weeks
Concurrent RT: 2 Gy/day, 5x/week, for 6 weeks, for a total of 60 Gy

Arm 2: Induction Chemoradiation and Panitumumab
Panitumumab 1x/week for 6 weeks
Paclitaxel & Carboplatin: 1x/week for 6 weeks
Concurrent RT: 2 Gy/day, 5x/week, for 6 weeks, for a total of 60 Gy
 

Statin Polyp Prevention in Patients with Resected Colon Cancer (NSABP P-5)

Cancer Types:  Colon
Member Institutions:  Ephrata Hospital, Jennersville Regional Hospital, Pocono Medical Center, Riddle Hospital, Sparta Cancer Treatment Center

Purpose:  Polyp Prevention in Patients with Resected Colon Cancer This Phase III randomized, placebo-controlled, double-blind study will evaluate the effectiveness of rosuvastatin in preventing the occurrence of adenomatous polyps of the colon or rectum, metachronous colorectal carcinoma, and colon cancer recurrence among colon cancer patients treated for cure.
Eligibillity:  General patient eligibility:
• Patients must have resected adenocarcinoma of the colon staged as AJCC Stage I or II.
• Patients must have had surgical resection of the colon adenocarcinoma with curative intent within 1 year prior to randomization. (Laparoscopically-assisted colectomy is
permitted.)
• Patients must have completed any adjuvant therapy prior to randomization.
• Patients who are taking cardioprotective low-dose aspirin at study entry must not have clinically significant toxicity, as determined by the investigator, that precludes continuation of aspirin, and the patient must be willing to continue aspirin therapy (81 mg or 325 mg) throughout study therapy.
• Colonoscopy requirements within 180 days prior to randomization:
• The patient must have either undergone a preoperative or postoperative documented
colonoscopy to the cecum (or small bowel anastomosis) with adequate bowel
preparation.
• All observed polyps must have been removed.

Conditions for patient ineligibility:
• Tumor with the distal border located < 12 cm from the anal verge
• Classic Familial Adenomatous Polyposis, Attenuated Familial Adenomatous Polyposis (i.e., 20 or more adenomas, either synchronous or metachronous), or Hereditary Nonpolyposis Colorectal Cancer (Lynch Syndrome)
Treatment:  Group 1- placebo daily for 5 years
Group 2 - Rosuvastatin 10 mg tablet
taken once daily x 5 years