Radiation Oncology/RTOG Trials

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Overview of RTOG Trials


RTOG Website Links[edit]

Please visit The RTOG Website for the latest trials and protocol information.

  • Finding RTOG trial results
    • From NCI Website:
      Search for RTOG Trial (change the number for the trial you're searching for) - provides list of publications
      Advanced Search - For any clinical trial. Be sure to set status of trial as active/closed; useful parameters include cooperative group, protocol id, and type of cancer.
    • Searching Pubmed for a specific RTOG trial - Search - (change the number to the trial you're searching for)


Pages by organ site[edit]


See also:

  • PMID 7558966 (1995) — "Evolution and accomplishments of the Radiation Therapy Oncology Group." Cox JD et al. Int J Radiat Oncol Biol Phys. 1995 Oct 15;33(3):747-54.
  • PMID 7635796 (1995) — "The evolution of Radiation Therapy Oncology Group (RTOG) protocols for nonsmall cell lung cancer." Byhardt RW et al. Int J Radiat Oncol Biol Phys. 1995 Jul 30;32(5):1513-25.
  • PMID 8655364 (1996) — Evolution of the Radiation Therapy Oncology Group clinical trials for head and neck cancer." Fu KK et al. Int J Radiat Oncol Biol Phys. 1996 Jun 1;35(3):425-38.


10-XX and later[edit]

  • 10-14 Protocol (PDF) (ongoing) - Breast - Phase II. Repeat breast preserving surgery and 3D-CRT PBI for local recurrence

00-XX to 09-XX[edit]

  • 09-37 Protocol (PDF) (ongoing) - SCLC - Extensive stage. Phase III. PCI vs PCI + consolidative extra-cranial RT
  • 09-21 Protocol (PDF) (ongoing) - Endometrium - Phase II. IMRT + concurrent cisplatin/bevacizumab + adjuvant carboplatin/paclitaxel
  • 09-20 (ongoing) - H&N - A phase III randomized trial of surgery followed by radiotherapy (IMRT) +/- cetuximab for intermediate risk HN SCCA
  • 09-15 Protocol (PDF) (ongoing) - NSCLC - Phase II randomized. SBRT inoperable central lesions 34/1 vs. 48/4
  • 08-13 Protocol (PDF) (ongoing) - NSCLC - Phase I/II. SBRT inoperable peripheral lesions 50/5 -> 60/5
  • 07-24 Protocol (PDF) (ongoing) - Cervix - High risk, early stage pts after Rad Hyst. Adjuvant Chemo/RT +/- adjuvant chemo.
  • 06-17 Protocol (PDF) (ongoing) - NSCLC - Phase III. Standard (60 Gy) vs. High Dose (74 Gy) concurrent with carbo/taxol +/- Cetuximab in Stage IIIA/IIIB
  • 05-24 (ongoing) - Bladder - A Phase I/II Trial of a Combination of Paclitaxel and Trastuzumab With Daily Irradiation or Paclitaxel Alone With Daily Irradiation Following Transurethral Surgery for Non-Cystectomy Candidates With Muscle-Invasive Bladder Cancer.
  • 05-22 Protocol (PDF) (2005-2009) - H&N - A phase III trial of concurrent accelerated radiation and cisplatin versus concurrent accelerated radiation, cisplatin, and cetuximab (C225) followed by surgery for residual disease for stage III and IV head and neck carcinomas.
  • 05-21 (ongoing) - Prostate - A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT Vs AS and 3DCRT/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk Prostate Cancer
  • 05-15 - NSCLC - Comparative study of GTV definition +/- PET scan
  • 04-38 (ongoing) - Liver - Phase I. Dose escalation. 35 Gy in 3.5 Gy/fx -> 50 Gy in 5.0 Gy/fx in patients with metastatic liver cancer.
  • 04-24 (ongoing) - Glioma - Phase II. High risk LGG (at least 3 risk factors: age >=40, tumor diameter >=6cm, tumor crossing midline, astrocytoma subtype, pre-op neurologic deficit). RT + Temozolomide. Comparison will be to historical EORTC patient population
  • 04-21 (Closed) - Head & Neck - Phase III. Locally recurrent, previously irradiated H&N: Concurrent Re-RT/Chemo vs. Chemo alone
    • Closed due to poor accrual
  • 04-17 Protocol (PDF) (Closed) - Cervix - Phase II. Locally advanced. Definitive RT + cisplatin + bevacizumab.
  • 04-15 (2006-2009) - Prostate - Phase III. Low risk, T1-T2, PSA < 10, G 2-6. Randomized to 73.8 Gy in 41 fractions (1.8 Gy/fx) vs 70 Gy in 28 fractions (at 2.5 Gy/fx).
  • 04-13 / NSABP B-39 (ongoing) Protocol -- "A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer"
  • 04-12 / SWOG S0332 Protocol - NSCLC - NSCLC Stage IIIA (N2) surgically resectable. Induction chemo vs chemo/RT followed by surgery then chemo.
    • Closed due to poor accrual
  • 04-11 (2005-6) - Pancreas - Phase II. RT + bevacizumab + capecitabine, with maintenance gemcitabine and bevacizumab
  • 03-30 Protocol - Sarcoma - Phase II. Preop thalidomide and RT or doxorubicin/ifosfamide/dacarbazine and RT
  • 03-21 - Prostate - Intermediate localized PCA. 45 Gy EBRT (no IMRT) + 19 Gy (2 fractions) HDR boost
  • 02-46 - Esophagus - Phase II. Paclitaxel Based Chemoradiation Regimen With Selective Surgical Salvage for Resectable Locoregionally Advanced Esophageal Cancer
  • 02-41 - SCLC - Phase I. Irinotectan + cisplatin + RT (45/30 BID or 70/35 QD in limited stage SCLC
  • 02-39 (ongoing) Protocol (PDF) - SCLC' - Phase II. Accelerated high dose RT (61.2 Gy in 5 weeks) with concurrent cisplatin/etoposide in limited small cell lung cancer
  • 02-35 Protocol link - NSCLC - PET for pre- and post- treatment assessment in locally advanced NSCLC
  • 02-34 (ongoing) - H&N - Post-op. A phase II randomized trial of surgery followed by chemoradiotherapy plus C225 (cetuximab) for advanced squamous cell carcinoma of the head and neck.
    • ASTRO Abstract 2007: RT + cisplatin or docetaxol + cetuximab is safe and feasible
  • 02-33 - Bladder - TURBT followed by induction chemo/RT (BID RT and randomized to Taxol + cisplatin vs 5-FU and cisplatin), evaluate tumor response, then consolidation chemo/RT (BID RT and randomized to same arm as above), then 4 cycles adjuvant chemo (Gemzar, Taxol, Cisplatin). Cystectomy for those who fail induction.
  • 02-32 (ongoing) - Prostate - Intermediate localized PCA. EBRT + PB vs. PB alone
  • 02-29 Protocol (PDF) (ongoing) - NSCLC - Phase II. IIIA-B, resectable. Preop chemo/RT -> surgery -> additional chemo.
  • 02-15 (ongoing) - Prostate - Treatment of ED. Sildenafil x 12 weeks crossover study.
  • 02-13 Protocol (PDF) - NSCLC - Phase I/II. Celebrex with RT in locally advanced NSCLC
    • Closed - poor accrual
  • 02-12 / Intergroup PCI99-01 (1999-2005) Protocol (PDF) - SCLC - PCI with Limited Disease SCLC - Intergroup study. PCI 25 Gy (at 2.5 Gy/fx) vs. 36 Gy (at 2/fx) vs. 36 Gy (at 1.5 BID).
  • 02-11 (2002-2004) GBM - CNS - RT with concurrent/adjuvant gefitinib
    • PMID 23182702: Well tolerated but no benefit over historical controls
  • 01-32 Protocol - Sarcoma - Phase II. GIST. Neoadjuvant and adjuvant Gleevec
  • 01-29 (2002-2005) Protocol (PDF) - H&N - Chemo/RT with conventional RT (70 Gy in 7 weeks) vs chemo/RT with concomitant boost (72 Gy in 6 weeks). Cisplatin (100 mg/m2) on days 1, 22, 43 (conventional) or 1 and 22 (C.B.). Enrolled selected Stage III-IV (T2N2-3M0, T3-4 Any N M0, no T1-2N1 or T1N2-3)
  • 01-26 (ongoing) - Prostate - High dose 3D-CRT/IMRT randomized to 70.2 Gy vs. 79.2 Gy
  • 01-14 (closed)(Protocol) - Gastric - Phase II. Randomized comparison of 2 chemo-RT regimens (Induction 5-FU/cisplatin/taxol + concurrent 5-FU/taxol + RT vs. induction cisplatin/taxol + concurrent cisplatin/taxol)
  • 00-24 (2001-3) - H&N - post-operative chemo/RT. Early Taxol (within post-op day 7-14) then RT to 60 Gy with cisplatin/taxol weekly for the last 3 weeks
  • 00-22 (2001-2005) Protocol (PDF) - H&N - Phase I/II study of conformal and intensity modulated irradiation for oropharyngeal cancer. Stage T1-2, N0-1.
  • 00-20 (Closed) - Pancreas - Phase II, weekly gemcitabine + paclitaxel + XRT followed by farnesyl transferase inhibitor R115777 for locally advanced pancreatic cancer
  • 00-19 (closed) - Prostate - Intermediate localized PCA. Phase II EBRT + PB
  • 00-12 (2001-2003) - Rectum (Protocol (PDF)) - Randomized Phase II. Preoperative chemo/RT.
    • PMID 16446336, 2006 — "Randomized Phase II Study of Neoadjuvant Combined-Modality Chemoradiation for Distal Rectal Cancer: Radiation Therapy Oncology Group Trial 0012." Mohiuddin M et al. J Clin Oncol, Vol 24, No 4 (February 1), 2006: pp. 650-655.
  • 00-11 (closed) - Prostate - Unfavorable pT3 PCA s/p RP. AST x 2 years alone vs. EBRT + AST x 2 years vs. EBRT alone. Study closed due to non-accrual.

90-XX to 99-XX[edit]

  • 99-15 (Closed; pending) (Intergroup/SWOG 9927) - Breast - post-mastectomy RT for Stage II with 1-3 positive LN (T1-2N1)
  • 99-14 (2000-2000) Protocol - H&N - "A phase II trial of concomitant boost radiation and concurrent cisplatin for advanced head and neck carcinomas."
  • 99-13 (2000-2) Protocol - H&N, Skin Toxicity - "A phase III comparison of Biafine to declared institutional preference for radiation induced skin toxicity in patients undergoing radiation therapy fro advanced squamous cell carcinomas of the head and neck."
  • 99-11 (2000-2003) Protocol (PDF) - H&N - "Phase II Study of Paciltaxel and Cisplatin in Combination with split course concomitant hyperfractionated re-irradiation in patients with recurrent squamous cell cancer of the head and neck."
  • 99-10 (1999-2004) - Prostate - Intermediate risk PCA. AST/2 followed by EBRT/AST vs. AST/7 followed by EBRT/AST.
  • 99-09 (Closed) Protocol - NSCLC - Phase II. Resected Stage II-IIIA, adjuvant RT + vaccine immunotherapy (CeaVac and TriAb)
  • 99-06 (1999-2002) Protocol (PDF) - Bladder - "Phase I-II RTOG study (99-06) of patients with muscle-invasive bladder cancer undergoing transurethral surgery, paclitaxel, cisplatin, and twice-daily radiotherapy followed by selective bladder preservation or radical cystectomy and adjuvant chemotherapy
  • 99-05 (1999-2003) - Endometrium - A Phase III Study of Adjuvant Postoperative Irradiation With or Without Cisplatin/Paclitaxel Chemotherapy following TAH/BSO for Patients with Endometrial Cancer. Grade 2-3 and Stage IC, IIA (with >50% myometrial invasion), or IIB.
  • 99-03 (2000-2003) Protocol (PDF) - H&N - RT vs RT + weekly erythropoietin for pts with H&N cancer and anemia
    • chapter link. Closed early due to other published data suggesting a decrease in locoregional control in pts receiving erythropoietin.
    • PMID 17716826 (2007): No difference in outcomes
  • 99-02 (closed early, Oct 2004) - Prostate - High risk, localized PCA. (AST/2 + EBRT) +/- TEE (Paclitaxel, Estramustine, and Etoposide). Study closed due to increased thromboembolic toxicity due to Emcyt.
  • 99-01 (2000-2) - H&N - Phase III, +/- GM-CSF for mucositis during RT.
  • 98-12 (Closed) - Pancreas - Phase II, weekly Taxol + XRT for unresectable pancreatic cancer
  • 98-04 (1999-2006) - Breast Surgery +/- RT for low or intermediate grade DCIS
  • 98-03 - CNS / GBM - Dose escalation.
  • 98-02 (1998-2002) - CNS glioma - A Phase II Study of Observation in Favorable Low-Grade Glioma and A Phase III Study of Radiation with or without PCV Chemotherapy in Unfavorable Low-Grade Glioma.
  • 97-16 (CALGB 9781) - Esophagus - Trimodality (cisplatin, 5-FU, XRT, surgery) vs surgery alone.
  • 97-14 (closed) - Prostate, Breast, Palliation - Mets to bone. 3 Gy x 10 vs. 8Gy x 1
    • Conclusion ASTRO 2003 Abstract : "Palliative external beam radiation therapy is very effective in providing pain relief, with complete or partial improvement in pain seen in 66% of patients. Pain and narcotic relief is equivalent for both 30 Gy in 10 fractions and 8 Gy in a single fraction. At 3 months follow-up, there is no difference between the two treatment arms, regardless of stratification. Treatment was well tolerated with few adverse effects."
  • 97-13 - Breast, Skin Toxicity - Randomized phase III study comparing Best Supportive Care to Biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoing breast irradiation.
  • 97-08 (1997-1999) - Endometrium - Phase II. Post-operative chemo+RT for "high risk" (Stage IC-III). EBRT + concurrent cisplatin, BT followed by cisplatin + taxol x 4 cycles.
  • 97-06 (1998-2000) - Bladder - Phase I/II trial. Operable muscle-invading. TURBT followed by cisplatin + BID RT followed by either selective bladder preservation or radical cystectomy and adjuvant chemotherapy.
  • 97-03 (Closed 1999) - Head & Neck - Phase II. Advanced Stage III-IV. Randomized to 1) 70 Gy / 7 weeks with daily cisplatin and 5-FU during the last 10 days of RT; 2) 70 Gy / 13 weeks every other week with concurrent daily hydroxyurea and 5-FU ; 3) 70 Gy / 7 weeks with weekly cisplatin and paclitaxel.
  • 97-02 (Intergroup, CALGB 9343) - Breast - lumpectomy + tamoxifen +/- RT for women > 70
  • 97-01 Protocol (PDF) - NSCLC - Phase III. Randomized chemo/RT vs RT alone for Stage IIIA-IIIB.
    • Closed for poor accrual in 1999
  • 96-16 (CALGB 9633) - NSCLC - Phase III. Resected T2N0 lung +/- adjuvant chemotherapy
  • 96-12 Protocol (PDF) - Vulva - Phase II, chemoradiation (5-FU + Mitomycin). Locally advanced (not treatable by radical vulvectomy).
    • Closed - poor accrual
  • 96-10 - H&N - Phase II. Reirradiation + chemotherapy in unresectable recurrent H&N
  • 96-09 Protocol (PDF) - SCLC - Phase II. "Study of paclitaxel, etoposide, and cisplatin chemotherapy combined with twice-daily thoracic radiotherapy for patients with limited-stage small-cell lung cancer
  • 96-08 (closed) - Prostate - Pathologically LN+. Indefinite AST +/- 70.2 Gy EBRT
  • 96-01 (closed) - Prostate - Post-op RT +/- Casodex 150 mg x 2 years for pT3 with PSA elevation.
  • 95-17 (1997-2000) - Breast - Phase I-II. Brachytherapy, LDR or HDR.
  • 95-11 Protocol (PDF) (CALGB 9334) - Sclerosis of pleural effusion by talc thoracoscopy vs talc slurry
  • 95-08 - CNS - 1-3 brain mets, randomized WBRT +/- radiosurgery - survival advantage for 1 met.
  • 95-05 - H&N - Basic science. Evaluation of NPC patients for tumor angiogenesis by microvessel density
    • PMID 15708253 (2005): No difference in survival based on MVD <60 vs MVD >=60
  • 94-17 (1995-97) - CNS - GBM. Phase II. RT 60 Gy + tirapazamine (3x/week x 12). Two dose levels.
  • 94-15 / INT 0146 / NCCTG 93-46-53 (1994-2001) - Colon - Laparoscopic colectomy vs open colectomy.
  • 94-13 (1995-99) - Prostate - High risk (>15%) of LN+. Neoadjuvant/concurrent vs adjuvant hormones; and whole-pelvic vs prostate only RT.
  • 94-10 - Lung - NSCLC medically inoperable or unresectable, Stage II-IIIB. Randomized to sequential chemo/RT vs one of two concurent chemo/RT arms (std or hyperfractionated).
  • 94-09 ECOG E4592 - NSCLC - Ancillary study to RTOG 91-05 / ECOG E3590 / INT 0115. Laboratory / Clinical correlative studies.
  • 94-08 (closed) - Prostate - Intermediate risk localized PCA. AST/2 followed by EBRT vs. EBRT alone.
  • 94-06 (closed) - Prostate - Phase I, 3D-CRT dose escalation, 68.4 - 79.2Gy.
    • Conclusion level V (78 Gy in 2 Gy/fx) ASTRO Abstract : "The rate of grade 3+ toxicity from 3DCRT with 78 Gy in 2.0 Gy fractions remains better than expected compared to historical controls. However, low-grade late toxicity is significantly higher in dose level V than dose level III. These differences may be dose and/or volume related."
    • Conclusion level IV (74 Gy in 2 Gy/fx) PMID 14967428 : "Tolerance to three-dimensional conformal radiotherapy with 74 Gy in 2-Gy fractions remains better than expected compared with historical controls. The magnitude of any effect from fraction size requires additional follow-up."
  • 94-05 - Esophagus - high (64.8 Gy) versus standard (50.4 Gy) dose
    • Chapter link
    • No difference in survival or loco-regional control
  • 94-04 - Lung - RT 60/30 +/- interferon beta
    • PMID 11955727 - Conclusion: "This multicenter, controlled Phase III trial failed to confirm the efficacy of Betaseron in patients receiving definitive radiotherapy for locally advanced, nonmetastatic non-small-cell lung cancer. The use of beta-interferon led to greater rates of both acute and late treatment-related toxicity."
  • 94-03 / INT 0144 / SWOG 9304 (1994-2000) Protocol - Rectum - Phase III. Post-op chemo/RT. 3-arm:
    1) bolus 5-FU -> RT + PVI 5-FU -> bolus 5-FU
    2) PVI 5-FU -> RT + PVI 5-FU -> PVI 5-FU
    3) bolus 5-FU + leucovorin + levamisole -> RT + bolus 5-FU + LV -> bolus 5-FU + LV + Lev
  • 94-02 / INT 0149 (1994-2002) - CNS, pure and mixed anaplastic oligodendroglioma. RT +/- neoadj PCV.
  • 94-01 / INT 0147 - Rectum - preoperative vs postoperative chemo/RT
    • Closed due to poor accrual
  • 93-12 (1994-1996) - SCLC - Phase II. LS-SCLC, AHFX 45/30 BID with concurrent cisplatin/ifosfamide
  • 93-11 - NSCLC - Dose escalation for NSCLC
  • 93-10 (1994-1997) - CNS Lymphoma - Phase II, chemo->RT
    • chapter link PMID 12488408, 2002 - HD-MTX based regimen combined with consolidative RT is superior to RT alone when the overall survival data are compared to historical data. However, patients over age 60 had significant risk of late toxicity from the combined treatment.
  • 93-09 (Intergroup 0139) - Lung - Randomized Trial of Chemoradiotherapy to 61 Gy [no S] versus Chemoradiotherapy to 45 Gy followed by Surgery [S] Using Cisplatin Etoposide in Stage IIIa Non-small Cell Lung Cancer (NSCLC): Intergroup Trial 0139, RTOG (9309)
  • 93-05 - CNS - Malignant gliomas, EBRT with BCNU +/- radiosurgery - no change in survival.
    • PMID 15465203 — "Randomized comparison of stereotactic radiosurgery followed by conventional radiotherapy with carmustine to conventional radiotherapy with carmustine for patients with glioblastoma multiforme: Report of Radiation Therapy Oncology Group 93-05 protocol." Souhami et al. Int J Radiat Oncol Biol Phys. 2004 Nov 1;60(3):853-60.
  • 93-02 - Melanoma - post-op H&N melanoma, 30 Gy/5 fx (twice/week) vs observation.
    • Closed due to poor accrual (20 pts enrolled).
  • 92-10 - Cervix - positive para-aortic LNs. HFx RT + concurrent 5-FU / cisplatin.
  • 92-08 - Anal - RT dose escalation, split course
    • PMID 18472363 (2008): Split-course worse outcomes compared with historical controls
  • 92-07 - Esophagus - brachytherapy boost
    • Swallowing function: PMID 11693897 — "Swallowing function and weight change observed in a phase I/II study of external-beam radiation, brachytherapy and concurrent chemotherapy in localized cancer of the esophagus (RTOG 9207)." Gaspar et al. Cancer J. 2001 Sep-Oct;7(5):388-94.
    • Final report: PMID 10699886 Full Text — "A phase I/II study of external beam radiation, brachytherapy, and concurrent chemotherapy for patients with localized carcinoma of the esophagus (Radiation Therapy Oncology Group Study 9207): final report." Gaspar et al. Cancer. 2000 Mar 1;88(5):988-95.
    • Preliminary report: PMID 9112458 Full Text — "A phase I/II study of external beam radiation, brachytherapy and concurrent chemotherapy in localized cancer of the esophagus (RTOG 92-07): preliminary toxicity report." Gaspar et al. Int J Radiat Oncol Biol Phys. 1997 Feb 1;37(3):593-9.
  • 92-05 - Lung - accelerated hyperfractionation
    • PMID 10776986 — "Accelerated hyperfractionation for bronchogenic cancer: Radiation Therapy Oncology Group 9205." Herskovic et al. Am J Clin Oncol. 2000 Apr;23(2):207-12.
  • 92-04 - Lung - Phase II, randomized induction chemo + concurrent chemo/RT vs concurrent chemo + hyperfractionated RT
  • 92-02 (1992-95) - Prostate - long-term (AST/2 + EBRT + 2 years AST) versus short-term (AST/2 + EBRT) androgren suppression; locally advanced.
  • 91-16 - Bladder - Pilot Study of the Quality of Life of Bladder Cancer Patients Being Treated on the Companion Protocol RTOG-8903
  • 91-15 - H&N - Phase III. Stage I-II. Chemoprevention with isotretinoin to prevent second malignant tumors.
  • 91-14 - CNS - High grade glioma. Quality of life and neuropsychological evaluation.
  • 91-12 - Cervix - A RANDOMIZED COMPARISON OF 5FU INFUSION + BOLUS CISPLATIN AS AN ADJUNCT TO RADIATION THERAPY, VS RADIATION ALONE IN SELECTED PATIENTS WITH STAGE 1-A2,1B,IIA, CARCINOMA OF THE CERVIX FOLLOWING RADICAL HYSTERECTOMY AND NODE DISSECTION
  • 91-11 - H&N - Larynx preservation: Induction Chemotherapy/XRT vs Concomitant Chemo/XRT vs XRT alone
  • 91-08 - H&N - Role of p105 as a predictor of outcome from prior RTOG protocols
    • PMID 7913703 (1994): Flow cytometry evaluation for p105 and DNA may be predictive
  • 91-06 - Lung - Phase II. Inoperable NSCLC. BID RT with concurrent daily oral etoposide + IV cisplatin.
  • 91-04 - CNS - Brain mets, unresected RPA class 1-2, compared 54.4 Gy BID boost vs 30 Gy in 10 fx.
    • PMID 9336134 — "A randomized phase III study of accelerated hyperfractionation versus standard in patients with unresected brain metastases: a report of the Radiation Therapy Oncology Group (RTOG) 9104." Murray KJ et al. Int J Radiat Oncol Biol Phys. 1997 Oct 1;39(3):571-4.
  • 91-03 Protocol - NSCLC - PFTs and serum markers evaluated after RT
  • 90-20 (closed) - Prostate - Phase II. EBRT + Etanidazole.
    • Conclusion PMID 8948352 : "Results of this trial regarding PSA response and clinical disappearance of disease are similar to historical controls and do not warrant further investigation of etanidazole as was done in this trial."
  • 90-19 (closed) - Prostate - High risk post-RP patients (ECE, SV+, SM+). RP +/- adjuvant EBRT.
  • 90-15 - Lung - Unresectable NSCLC. Phase I/II BID RT + concurrent chemotherapy.
  • 90-05 - CNS - Radiosurgery, maximum tolerated dose, for brain mets and primary brain tumors. Established 24 Gy, 18 Gy, and 15 Gy for tumors < 2 cm, 2.1-3 cm, and 3.1-4 cm.
  • 90-03 - H&N - Compare Daily Hyperfractionation, Accelerated Hyperfractionation with a Split, Accelerated Fractionation with Concomitant Boost, and Standard Fractionation Radiotherapy for Squamous Cell Carcinomas of the Head and Neck
  • 90-01 (1990-97) - Cervix - Pelvis+Paraaortic RT vs Pelvic RT + Chemo

80-XX to 89-XX[edit]

  • 89-05 - CNS - Brain mets. RT +/- bromodeoxyuridine .
  • 89-02 - Rectum - Local excision for distal rectal CA.
  • 88-24 - H&N - post-op concurrent chemo/RT (phase II, not randomized)
  • 88-23 (closed) - Liver - Phase I/II. Unresectable HCC. Induction CT/RT, followed by intra-arterial cisplatin and I-131 Antiferritin
    • Conclusion PMID 9612600 "Patients with unresectable alpha-fetoprotein-positive hepatocellular carcinoma experienced improved survival and decreased toxicity when managed with post-induction cycles of intra-arterial cisplatin as compared with intravenous doxorubicin and 5-FU. Intravenous 131I-polyclonal antiferritin did not improve survival when added to either post-induction regimen but dramatically increased hematologic toxicities."
  • 88-22 (closed) - Palliation - Prostate or Breast bone mets. Dose-escalated fractionated hemibody irradiation
    • PMID 8823257 : "The maximum tolerated dose of fractionated (2.50 Gy) HBI was found to be 17.5 Gy. The major dose limiting toxicity was hematological (thromboleukopenia). There was not a significant dose response effect on occult disease (appearance of new disease) or in the requirement for additional treatment, although certain trends were noted for the higher doses. When only patients completing assigned HBI from RTOG 82-06 and 88-22 were compared, there was no difference in the time to new disease or additional treatment in the treated field. Based on the investigative parameters of this study, single high-dose HBI was as effective as fractionated HBI."
  • 88-17 (Intergroup 0099) - H&N - Nasopharynx chemo/RT vs RT (Al-Sarraf)
  • 88-15 (INT 0096) - SCLC - Phase III. Standard RT 45/25 vs. AHFX 45/30 BID. Concurrent cisplatin/etoposide
  • 88-14 - Bladder - Phase II. Neoadjuvant Chemotherapy with MCV (MTX/CDDP/VBL) with Intraoperative Electron Beam Radiotherapy and Pre- and Postoperative External Beam Radiotherapy in Patients with Invasive Bladder Carcinoma
  • 88-09 - H&N - Phase I/II, comparing two accelerated fractionation: Split course 1.6 Gy BID to 67.2 Gy, 2 week break after 38.4 Gy vs. 1.8 Gy + 1.5 Gy concomitant boost for last 11 fractions to 70.5 Gy
  • 88-08 / ECOG 4588 - NSCLC - Unresectable Stage II-IIIB. std RT vs induction chemo/RT vs hyperfractionated RT.
  • 88-06 - CNS lymphoma - Phase I/II. HIV-negative CNS lymphoma treated with CHOD x 2 -> WBRT to 41.4 Gy boosted to 59.4 Gy.
  • 88-04 - NSCLC - Phase II. Unresectable. Induction/concurrent vinblastine + cisplatin.
  • 87-05 - Hyperthermia - Phase I/II. Radiotherapy and Hyperthermia in Patients with Selected Measurable Superficial Tumors
  • 87-03 - Hyperthermia - Phase I/II. Combined Modality Therapy with DDP and Regional Hyperthermia in Patients with Malignancies of the Pelvis and Lower Abdomen
  • 86-10 (closed) - Prostate - Concurrent and adjuvant Zoladex + Flutamide with XRT. Bulky primary disease (>25 cc)
    • PMID 18172188 (2008)
    • Conclusion PMID 11483335 : "In patients with Gleason score 2--6 carcinoma of the prostate, a short course of androgen ablation administered before and during radiotherapy has been associated with a highly significant improvement in local control, reduction in disease progression, and overall survival."
  • 86-08 - Rectum, Cervix, Bladder - Phase I/II. WR-2721 Administered Before Protracted Fractionated Radiotherapy in Patients with Cancer of the Rectum, Cervix, or Bladder
  • 85-31 (closed) - Prostate - N+ or cT3/pT3, Zoladex at time of radiation vs radiation alone. Excluded bulky disease (see 86-10) unless there was +LN outside of pelvis.
    • Conclusion PMID 15817329 : "In a population of patients with unfavorable prognosis carcinoma of the prostate, androgen suppression applied as an adjuvant after definitive RT was associated not only with a reduction in disease progression but in a statistically significant improvement in absolute survival. The improvement in survival appeared preferentially in patients with a Gleason score of 7-10."
  • 85-28 - CNS - solitary brain met, Phase I/II, dose escalation with hyperfractionated boost.
    • PMID 8435812 — "Improved survival duration in patients with unresected solitary brain metastasis using accelerated hyperfractionated radiation therapy at total doses of 54.4 gray and greater. Results of Radiation Therapy Oncology Group 85-28." Epstein BE et al. Cancer. 1993 Feb 15;71(4):1362-7.
    • PMID 8330997
    • NOTE:Countered by 91-04
  • 85-06 - Bile Duct - Phase I/II. Unresected, resected but residual, or locally recurrent biliary duct cancer. Intra-op RT (14-22 Gy) followed by EBRT (45-50 Gy). 2/8 pts alive at publication w/ median follow-up 10.5 months
    • PMID 1514529 -- Intraoperative radiation therapy of extrahepatic biliary carcinoma: a report of RTOG-8506. (Wolkov HB, Am J Clin Oncol. 1992 Aug;15(4):323-7.)
  • 85-02 (1985-89) - Gyn / Palliation - Phase I/II? Palliation for advanced pelvic malignancies. 3.7 Gy BID to 44.4 Gy with break after 4th and 8th fractions. Break duration randomized 2 vs 4 wks.
  • 85-01 - Esophagus - XRT alone vs XRT/Chemo - increased OS for T1-3 N0-1 M0 squamous cell and adenocarcinomas
    • Update: Abstract Full text — "Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG 85-01). Radiation Therapy Oncology Group." Cooper et al. JAMA. 1999 May 5;281(17):1623-7.
    • First report: Abstract — "Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus." Herskovic et al. N Engl J Med. 1992 Jun 11;326(24):1593-8.
    • Race: Abstract: Does Race Influence Survival? — "Does race influence survival for esophageal cancer patients treated on the radiation and chemotherapy arm of RTOG #85-01?" Streeter et al. Int J Radiat Oncol Biol Phys. 1999 Jul 15;44(5):1047-52.
  • 84-19 - Protocol Recurrent or persistent tumors -- Phase III Randomized Study of Interstitial Thermoradiotherapy vs Interstitial Radiotherapy Alone for Metastatic, Recurrent, or Persistent Tumors
  • 84-12 / GOG 71 (1984-91) - Cervix - TREATMENT OF PATIENTS WITH SUB-OPTIMAL (BULKY) STAGE 1B CARCINOMA OF THE CERVIX. A RANDOMIZED OF RADIATION THERAPY VS RADIATION PLUS ADJUVANT EXTRAFACIAL HYSTRECTOMY
  • 84-11 - H&N, Breast, Sarcoma - Phase III Randomized Comparison of Radiotherapy plus Hyperthermia vs Radiotherapy Alone in the Treatment of Patients with Head and Neck Carcinoma, Breast Cancer, or Soft Tissue Sarcoma Amenable to Potentially Curable Radiotherapy
  • 84-07 (1984-89) - Lung NSCLC - Phase I/II, concomitant boost: 45 Gy/1.8 (daily) + 18 Gy/10 fx (2-3x/week) = 63 Gy; escalate to 50.4 + 19.8 Gy = 70.2 Gy / 5.5 wks or 45 + 25.2 = 70.2 Gy / 5 wks.
  • 84-05 (closed) - Liver - Phase I/II dose escalation, GI liver mets, whole liver RT 1.5 Gy BID escalated to 27, 30, 33, 36 Gy (not reached).
    • Conclusion: PMID 8365932 "The study design could not credibly establish a safe dose for hepatic irradiation, however, it did succeed in determining that 33 Gy in fractions of 1.5 Gy is unsafe, carrying a substantial risk of delayed radiation injury. The absence of apparent late liver injury at the 27 Gy and 30 Gy dose levels suggests that a prior clinical trial of adjuvant hepatic irradiation in patients with resected colon cancer may have employed an insufficient radiation dose (21 Gy) to fully test the question."
  • RTOG 84-03 - Lung NSCLC / PCI - RT alone vs RT + PCI for NSCLC (non-metastatic).
  • 83-19 (closed) - Liver - Phase III. HCC. CT/RT Induction followed 1 month later by CT +/- 131-I-Antiferritin
    • Conclusion PMID 9612600: "Intravenous 131-I-polyclonal antiferritin did not improve survival when added to either post-induction regimen but dramatically increased hematologic toxicities."
  • 83-15 (1983-87) - CNS Lymphoma - Phase II. RT alone, 40 Gy WBRT + 20 Gy boost.
  • 83-13 (1983-1987) - H&N - hyperfractionation dose escalation: 1.2 Gy BID to 67.2 Gy, 72.0 Gy, 76.8 Gy, 81.6 Gy
    • PMID 2180866 (Preliminary): Higher LC with 72.0 and 76.8 Gy hyperfractionated, led to RTOG 90-03
    • PMID 7790242 (Long-term): No increase in late toxicity
  • 83-12 - Lung NSCLC - Phase I/II, T3-T4 NSCLC. Concomitant boost at 1.8 Gy/fx to 50.4 Gy (elective nodal). Primary tumor to 2.68 Gy/day to total of 75 Gy in 28 fx.
  • 83-11 - Lung NSCLC - Phase I/II dose escalation, randomized to 1.2 Gy BID to 60.0, 64.8, 69.6 Gy, 74.4 Gy or 79.2 Gy.
  • 83-03 - Bladder - Phase I/II. Dose escalation 60.0 Gy, 64.8 Gy, or 69.6 Gy. Evaluation of Twice-Daily Fractional Radiotherapy for Locally Advanced Stage B/C/D Transitional Cell and Unresectable Squamous Cell Carcinoma of the Bladder
  • 83-07 (closed) - Prostate - XRT + DES vs XRT + Megace - similar results but different toxicities
    • Conclusion PMID 7721614 : "The results of the study indicate comparable efficacy (using tumor clearance as an end point) of DES and Megestrol. Although DES appears more effective in suppressing testosterone, it is also associated with a higher incidence of drug-related toxicity."
  • 83-05 - Melanoma - dose per fraction. 4 x 8.0 Gy (32 Gy) once weekly vs 20 x 2.5 Gy (50 Gy) 5 days/week.
    • PMID 1995527 — "Fraction size in external beam radiation therapy in the treatment of melanoma." Sause WT et al. Int J Radiat Oncol Biol Phys. 1991 Mar;20(3):429-32.
  • 83-01 (closed) - Liver - Phase I/II. HCC. Induction CT+RT, followed 1 month later by 131-I-antiferritin + CT
    • Conclusion PMID 2415692: "These studies have demonstrated the toxicity and therapeutic activity of 131I antiferritin and the emerging role of radiolabelled antibody in cancer therapy."
  • 82-06 (closed) - Palliation - Bone mets. 30 Gy EBRT +/- 8 Gy hemibody irradiation
    • Conclusion PMID 1374061 : "This clinical trial demonstrates that HBI has the potential to be used to treat systemic and occult metastases, particularly if both halves of the body can be treated."
  • 81-17 - H&N - Piloted RT + chemo. Standard RT with concomitant cisplatin (100 mg/m2) q3weeks x 3 courses. Included oropharynx, nasopharynx, oral cavity.
  • 81-16 - H&N - Phase I/II. Induction cisplatin/5-FU + surgery + RT (42 patients) or surgery + sequential cisplatin/5-FU + RT (29 patients)
  • 81-10 - Bladder - Phase III Photon vs Mixed Beam Preoperative Radiotherapy for Stage B/C/D Carcinoma of the Bladder
  • 81-08 - Lung NSCLC - feasibility study of hyperfractionated RT
  • 81-06 - Bladder - Phase III Randomized Comparison of Sandwich vs Standard Preoperative Adjuvant Radiotherapy in Stage B/C Bladder Cancer
  • 81-05 - Bladder - Phase I/II Misonidazole and Radiotherapy for Inoperable Bladder Cancer
  • 80-03 (closed) - Liver - Phase III. Liver mets. RT +/- radiosensitization with misonidazole

70-XX to 79-XX[edit]

  • 79-28 (closed) - Liver - Phase I/II. 131-I-Antiferrin, Liver RT and ADR/5-FU
    • Conclusion: PMID 6275989 - "Present results suggest that further clinical studies with isotopic immunoglobulin are indicated."
  • 79-16 (1979-83) - CNS - Brain mets. Randomized to 30/10 vs 30 Gy/6 fx/3 wks, and +/- misonidazole
  • 79-13 - H&N - Hyperfractionated 1.2 Gy BID vs. standard fractionation
  • 78-26 - Bladder - Photon Radiotherapy vs Pion Radiotherapy for Transitional Cell Carcinoma of the Urinary Bladder
  • 78-17 - Hypoxia - Phase II Study of Misonidazole plus Intraoperative Radiotherapy for Nonresectable Carcinomas
  • 78-16 - Hyperthermia - Phase I-II Hyperthermia (43.5 Degrees Centigrade) Before and After Radiation Treatment for Human Tumors
  • 78-10 (closed) - Palliation - Bone mets. Hemibody dose escalation
    • Conclusion: PMID 2423225 - "HBI achieves pain relief sooner and with less evidence of pain recurrence in the irradiated area than conventionally treated patients. The most effective and safest of the HBI doses tested were 600 rad for the upper HBI and 800 rad for the lower or mid-HBI."
  • 78-03 - H&N - Phase I/II. Induction cisplatin + bleomycin prior to RT
  • 77-08 - H&N - PI/II. Advanced patients. Induction VCR+Bleo+MTX
  • 77-06 (closed) - Prostate - Prostate field vs. Whole pelvis + prostate boost. Stage A2-B, N0.
    • Conclusion: PMID 3058656 - "The results of the study revealed no statistically significant benefit of elective pelvic irradiation.
  • 77-03 - H&N - Phase I/II. Hyperfractionation pilot: 1.25 Gy BID and 1.5 Gy BID
    • chapter link
    • 1.2 Gy BID tolerable; 1.5 Gy BID too toxic. Led to RTOG 79-13
  • 76-15 - H&N - Phase I-II. Neoadjuvant and concurrent chemo-RT (VBM=VCR,Bleo,MTX)
    • Too toxic
  • 76-13 - H&N - Phase I-II. Combined multidrug chemo/RT (Cytoxan,VCR,Bleo) + adjuvant chemo
  • 76-12 - Bladder - Preoperative or Postoperative Radiotherapy or Radiotherapy Alone for Clinical Stage B1 or B2 or C Bladder Carcinoma
  • 76-08 - Cervix - Phase III. Photons vs. photons + neutrons
    • No difference
  • 76-06 (1976-79) - CNS - Brain mets, favorable patient population (controlled primary, no extracranial mets). Rand to 30/10 vs 50/20
  • 76-05 (closed) - Liver - Phase I. Treatemnt of liver mets with RT
  • 74-02 - Bone metastases - Solitary 40.5/15 vs. 20/5; Multiple 30/10 vs. 15/5 vs. 20/5 vs. 25/5
  • 74-01 / ECOG 1374 - CNS - High grade glioma. 1) 60 Gy whole brain vs 2)60 Gy + 10 Gy boost vs 3)60 Gy + BCNU vs 4)60 Gy + CCNU + DTIC
  • 73-61 (1973-76) - CNS - Brain mets. Various doses: 20/5, 30/10, 40/15. Ultra-rapid: 6 Gy x 2. (RTOG 69-01 and 73-61 are grouped together.)
  • 73-02 - Lung NSCLC - T4 or N3 (IIIB). Palliation. Randomized to 30 Gy, 40 Gy continuous, or 40 Gy split.
  • 73-01 - Lung NSCLC - Stage III. Randomized to 40 Gy split course or 40 Gy, 50 Gy, or 60 Gy continuous.
  • 71-05 - Cervix - Phase III. Stage IIB-IVA. Randomized to RT 51/30 vs. split course 25/10 + 25/10. Both followed by BT boost 30 Gy LDR
  • 71-04 - Bladder - Phase III. Stage C or D1. Randomized to RT 60/30 vs. split course 27.5/10 + 27.5/10
  • 71-03 - H&N - Phase III. Nasopharynx. Randomized to RT 66/33 vs. split course 30/10 + 30/10
  • 71-02 - H&N - Phase III. Base of tongue. Randomized to RT 66/33 vs. split course 30/10 + 30/10
  • 71-01 - H&N - Phase III. Tonsillar fossa. Randomized to RT 66/33 vs. split course 30/10 + 30/10

Pre 70-XX[edit]

  • 69-01 (1971-73) - CNS - Brain mets. Various doses: 30/10, 30/15, 40/15, 40/20. Ultra-rapid: 10 Gy x 1. (RTOG 69-01 and 73-61 are grouped together.)
  • 68-01 (1968-1972) - H&N - Phase III. Stage III-IV OC, OP, SGL, HP. Randomized to RT alone vs. induction MTX followed by RT