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.
GI
PROTOCOLS
1. RTOG 1010
HER2-Positive Esophageal Adenocarcinoma
Eligibility: Primary adenocarcinoma of esophagus involves the mid (up to 25 cm), distal, or esophagogastric junction (may involve the stomach up to 5 cm); Tissue must be submitted and be HER2 positive by centralized testing; stage T1N1-2, T2-3N0-2; Performance status 0-2; No prior chemo or RT for this cancer. Rx: Trastuzumab + Taxol + Carboplatin w/RT > surgery > Trastuzumab versus Taxol + Carboplatin w/RT > surgery. (TRASTUZUMAB SUPPLIED)
2. RTOG 0848
Resected Head of Pancreas Adenocarcinoma
Eligibility: Complete excision of primary tumor (head of pancreas); stage T1-3, N0-1, M-0 interval between surgery and 1st step reg between 21-56 days; no prior chemo or RT for this cancer; Performance status 0,1. Rx: (1st randomization): Gemcitabine versus Gemcitabine + Erlotinib. If no progression (2nd randomization): 1 cycle chemo versus 1 cycle chemo > RT with Capecitabine or 5-FU. (ERLOTINIB SUPPLIED)
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 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. (NO DRUG SUPPLIED)
3. RTOG 0831
Prevention of Erectile Dysfunction
Eligibility: Clinical stage T1b-T2b adenocarcinoma of prostate; clinically neg lymph nodes; no bone mets; Planned external RT alone OR brachytherapy (combined Rx are excluded); RT to pelvic and/or para-aortic LN’s are not allowed; Perf status 0 or 1; No use of LHRH agonist androgen suppression w/in last 6 mos. Rx: Tadalafil 5 mg x 24 wks versus Placebo. (TADALAFIL/PLACEBO PROVIDED)
HEAD
AND NECK PROTOCOLS
1. RTOG 0920
SCC (and variants) of the Oral Cavity, Oropharynx or Larynx
Eligibility: Clinical stage T1, N1-2 or T2-3, N0-2, M0; gross total resection of primary with curative intent; must enroll within 7 weeks post-op; tumor must have 1 or more intermediate risk factors (see protocol p17 section 3.1.3.1- 3.1.3.6); performance status 0-1; Rx: IMRT alone versus IMRT + Cetuximab (CETUXIMAB SUPPLIED) IMRT credentialling required- see protocol p. 20, section 5.3
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). (NO DRUG SUPPLIED)
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
NCI =
National Cancer Institute
NSABP =
National Surgical Adjunct Breast and Bowel Project
RTOG =
Radiation Therapy Oncology Group
SCUSF = SunCoast CCOP Research Base
SWOG =
Southwest Oncology Group
REVISED 12/2/11
