RTOG protocols approved for use at
Summit Medical Center,  Doctors Medical Center and East Bay Radiation Oncology Center
Intergroup SWOG/RTOG (intergroup) approved at all CCOP Institutions.

BREAST PROTOCOLS

1. RTOG 0413 (NSABP B-39)
Stages 0 - II Treated by Lumpectomy (Closed to the following low risk groups: women >/= 50 yrs with DCIS only or with node negative, hormone positive invasive cancer)
Eligibility: tumor < 3.0 cm; no more than 3 positive nodes; must enroll prior to start of adj chemo and within 42 days of last surgery for breast cancer: RX: Whole breast irradiation versus partial breast irradiation.

CNS PROTOCOLS

1. RTOG 0227
Primary Central Nervous System Lymphoma
Eligibility: diagnosis by biopsy, CSF, or vitreous cytology (in assoc with measurable intraparenchymal tumor); performance status 0 - 2; life expectancy >/= 8 weeks; no systemic lymphoma; no prior RT or chemo; no active infection, hep B, HIV or AIDS: RX: Retuximab + MTX with leucovorin rescue + Temozolomide followed by RT followed by Temozolomide.

1. RTOG 0513 (Temporarily Closed)
Newly Diagnosed Supratentorial Glioblastoma Multiforme
Eligibility: Diagnosis by surgical biopsy or excision; supratentorial as determined by pre-op CT/MRI; Performance status 0-1; neurologic function status 0-2; must begin Rx within 5 wks of surgery: RX: Temozolomide, Motexafin Gadolinium and 60 Gy fractionated RT.

GU PROTOCOLS: Prostate

1. RTOG 0232
Prostate Cancer
Histologically confirmed adenocarcinoma stage T1c - T2b. Gleason 7 if PSA < 10 or Gleason < 7 if PSA 10-20. Zubrod 0-1. No prior chemo or pelvic RT. No previous hormonal tx beginning < 2 mos or > 6 mos prior to rando. Arm 1: Radiation + Permanent Brachytherapy Arm 2: Brachytherapy alone.

2. RTOG 0415
Favorable Risk- Stage T1-2c
Eligibility: dx within 180 days; preRx PSA < 10ng/ml; gleason score < 7; no radical surgery or cryosurgery for prostate cancer; no prior or planned androgen deprivation or orchiectomy: RX: 3D-CRT or IMRT 73.8 Gy in 41 fractions versus 70 Gy in 28 fractions.

3. RTOG 0518
Prevention of Osteoporosis and Fractures in Pts Receiving RT and LHRH Agonists
Eligibility: high grade and/or locally advanced disease; diagnosis within 6 months of enrollment; may not have received LHRH agonists for > 12 wks; no prior pelvic RT: RX: Radiation therapy and LHRH therapy (see protocol for options) plus Zoledronic acid/placebo q 3 months x 3 yrs.

4. RTOG 0534
Rising PSA after Radical Prostatectomy
Eligibility: lymph node negative adenoCa of the prostate treated by prostatectomy; post surgical PSA of >/= 0.2 - < 2.0; pathologic T3N0/Nx dz or T2N0/Nx dz if surgical margin positive or prostatic fossa or urethral-vesical anastomosis biopsies are positive; PSA doubling time > 6 mos prior to registration: RX: Prostate bed RT (PBRT) versus PBRT + neoadjuvant and concurrent short term androgen deprivation (NC-STAD) versus Pelvic lymph node RT + PBRT + NC-STAD.

5. RTOG P0126
Localized Prostate Cancer.
Eligibility: Histologically confirmed adenocarcinoma. Stage T1b-T2b, Gleason score 2-6, and PSA > 10 but < 20 or Stage T1b-T2b, Gleason score 7, PSA < 15. No previous chemo or RT. No distant mets. Arm 1: 3D-CRT: 72.93 Gy in 39 fractions. Arm 2: 3D-CRT: 82.28 Gy in 44 fractions. No previous hormonal tx (exclusive of finasteride or phytoestrogen prep no less than 3 mos from rando).

GYN PROTOCOLS

1.  RTOG 0418 (The endometrial arm of the study closed 6/15/07)
Endometrial or Cervical Cancer
Eligibility: hysterectomy within 7 weeks of enrollment; pts with endomet ca must also have BSO; must require post-op RT or chemo/RT; performance status 0-2; RX: endometrial ca pts- IMRT 28 fractions over 5.5 wks; cervical ca pts- IMRT 28 fractions over 5.5 wks plus concurrent cisplatin.

HEAD AND NECK PROTOCOLS

1. RTOG 0522
Stages III & IV SCC of the Oropharynx, Hypopharynx or Larynx
Eligibility: T2, N2-3, M0 or T3-4, any N, M0; performance status 0 - 1; no prior chemo for this disease; no prior RT that involved the area of this cancer; no surgical treatment other than bx of primary and nodal sampling: RX: concurrent accelerated radiation + cisplatin versus concurrent accelerated radiation + cisplatin and cetuximab both arms followed by surgery for selected patients.

LUNG PROTOCOLS: Non-Small Cell

1. RTOG 0617
Unresectable Stage III A or B NSCLC
Eligibility: Newly diagnosed dz; no SC or contralateral hilar adenopathy; no prior chemo for this cancer; no prior RT to region of this cancer; performance status 0-1; <10% wt loss in past month: RX: Standard dose (60 Gy) versus high dose (74 Gy) CRT with concurrent and consolidation Carbo/Taxol.

2. RTOG 9616
Non-small Cell Lung Cancer: Stage 1
Histologically documented NSCLC. Complete surgical reception (lobectomy or pneumenectomy). No prior chemo or RT. Arm 1: Observation. Arm 2: Concurrent Carboplatin + Taxol x 4 cycles. Temporarily Closed.

3. RTOG L0127
Phase III trial of selenium vs. placebo supplementation in patients with resected stage I non-small cell lung cancer.

LUNG PROTOCOLS: Small Cell

1. CALGB 30610
Limited stage
Eligibility: No prior resection; no prior chemo or RT for SCLC; no prior thoracic RT; measurable or non-measurable dz; performance status 0-2; RX: Cisplatin/Etoposide X 4 cycles plus one of three radiotherapy regimens (3 arm study). 

MISCELLANEOUS PROTOCOLS

1.  RTOG 0433 (NCIC SC.20)
Re-irradiation of Bone Metastases
Eligibility: Histologic/cytologic dx of cancer; radiographic confirmation of bone mets corresponding to painful area; worst pain score > 2/10; KPS > 50; prior RT for bone met >  4 weeks ago; initial RT field must be reproducible for reirradiation: RX: 1 fraction (8 Gy) vs 5-8 fractions (20 Gy).

Abbreviations
CALGB = Cancer and Leukemia Group B
CTSU = Cancer Trials Support Unit
ECOG = Eastern Cooperative Oncology Group
HLMCC = H. Lee Moffitt Cancer Center
NCI = National Cancer Institute
NSABP = National Surgical Adjunct Breast and Bowel Project
RTOG = Radiation Therapy Oncology Group
SWOG = Southwest Oncology Group

REVISED 4/7/08