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 0825
Newly Diagnosed Glioblastoma
Eligibility: glioblastoma or gliosarcoma confirmed by central path lab prior to registration; must be enough tissue for analysis of MGMT status and determination of molecular profile; tumor must have supratentorial component: Step 1 reg: tissue screening; Step 2 reg; RT + concurrent Temozolomide x 3 weeks; Step 3 rando: RT + concurrent Temozolomide +/- Bevacizumab x 3 weeks followed by Temozolomide +/- Bevacizumab X 12 cycles maximum. (BEVACIZUMAB/PLACEBO 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)
HEAD
AND NECK PROTOCOLS
1. RTOG 0619
Stage III or IV SCC of Oral Cavity, Oropharyn , Larynx or Hypopharynx (exluding lip, nasopharynx and sinuses)
Eligibility: gross total resection within 3-6 wks of registration; must have a high risk factor on pathology (extracapsular nodal extension and/or microscopically positive margin); no distant mets; performance status 0-1: Rx: RT + Cisplatin vs RT + Cisplatin + Vandetanib. (VANDETANIB SUPPLIED)
2. 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: 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. (NO DRUG SUPPLIED)
2. RTOG L0127
Phase III trial of selenium vs. placebo supplementation in patients with resected stage I non-small cell lung cancer. (SELENIUM/PLACEBO SUPPLIED)
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).
2. RTOG 0614
Prevention of Cognitive Dysfunction in Pts Receiving WBRT
Eligibility: pts must have solid tumor malignancy with brain mets; pts must be RTOG RPA class I or II (see protocol appendix IV); controlled systemic dz for 3 months or more; Prior surgical resection or radiosurgery for brain mets allowed; systemic Rx completed > 14 days prior to entry: Rx: WBRT + Memantine or Placebo. (MEMANTINE/PLACEBO SUPPLIED)
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 8/25/10
