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Phase III Prostatic Irradiation vs Pelvic Irradiation plus Prostate Boost for Stage A2/B Prostatic Adenocarcinoma

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed80 and underNCIRTOG-7706
RTOG-77-06

Objectives

I.  Determine the value of irradiation of the prostate only vs. pelvic 
irradiation with prostate boost in patients with Stages A2 and B 
adenocarcinoma of the prostate.
II.  Compare the morbidity and complications of these two radiotherapeutic 
regimens.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with Stages A2 and B 
adenocarcinoma of the prostate who have not had potentially curable surgery 
and who have no evidence of lymph node metastasis on lymphangiogram.  Patients 
with suspicious lymphangiograms may be admitted only if node biopsies are 
negative.  Bone marrow and renal function must be adequate.  Patients may not 
have had previous radiation therapy, except for skin cancer irradiated outside 
the present treatment fields, and there may be no previous or concurrent 
cancers other than skin cancer.  Patients must have a Karnofsky performance 
status of at least 50 percent and may not be over the age of 80.  There must 
be no history of multiple pelvic surgeries that would contraindicate pelvic 
irradiation.

Expected Enrollment

150 patients will be entered onto each arm over 24-30 months (299 total as of 
September 1981).  Protocol closed July 1983.

Outline

Randomized study.
Arm I:  Radiotherapy.  Prostate irradiation.  Megavoltage equipment with 
effective photon energies greater than 1 MeV or Co-60.
Arm II:  Radiotherapy.  Pelvic irradiation with prostate boost.  Same 
equipment as in Arm I.

Published Results

Asbell SO, Martz KL, Shin KH, et al.: Impact of surgical staging in evaluating the radiotherapeutic outcome in RTOG #77-06, a phase III study for T1BN0M0 (A2) and T2N0M0 (B) prostate carcinoma. Int J Radiat Oncol Biol Phys 40 (4): 769-82, 1998.[PUBMED Abstract]

Asbell SO, Caplan RJ, Perez CA, et al.: Impact of surgical staging in evaluating the radiotherapeutic outcome in RTOG phase III study for T1b-T2NOMO prostatic carcinoma: RTOG #77-06. [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-1681, 512, 1995.

Asbell SO, Martz KL, Pilepich MV, et al.: Impact of surgical staging in evaluating the radiotherapeutic outcome in RTOG phase III study for A2 and B prostate carcinoma. Int J Radiat Oncol Biol Phys 17 (5): 945-51, 1989.[PUBMED Abstract]

Asbell SO, Krall JM, Pilepich MV, et al.: Elective pelvic irradiation in stage A2, B carcinoma of the prostate: analysis of RTOG 77-06. Int J Radiat Oncol Biol Phys 15 (6): 1307-16, 1988.[PUBMED Abstract]

Pilepich MV, Asbell SO, Krall JM, et al.: Correlation of radiotherapeutic parameters and treatment related morbidity--analysis of RTOG Study 77-06. Int J Radiat Oncol Biol Phys 13 (7): 1007-12, 1987.[PUBMED Abstract]

Related Publications

Roach M 3rd, Lu J, Pilepich MV, et al.: Race and survival of men treated for prostate cancer on radiation therapy oncology group phase III randomized trials. J Urol 169 (1): 245-50, 2003.[PUBMED Abstract]

Roach M 3RD, Lu J, Pilepich MV, et al.: Predicting long-term survival, and the need for hormonal therapy: a meta-analysis of RTOG prostate cancer trials. Int J Radiat Oncol Biol Phys 47 (3): 617-27, 2000.[PUBMED Abstract]

Roach M, Lu J, Pilepich MV, et al.: Four prognostic groups predict long-term survival from prostate cancer following radiotherapy alone on Radiation Therapy Oncology Group clinical trials. Int J Radiat Oncol Biol Phys 47 (3): 609-15, 2000.[PUBMED Abstract]

Valicenti R, Lu J, Pilepich M, et al.: Survival advantage from higher-dose radiation therapy for clinically localized prostate cancer treated on the Radiation Therapy Oncology Group trials. J Clin Oncol 18 (14): 2740-6, 2000.[PUBMED Abstract]

Roach M 3rd, Lu J, Pilepich MV, et al.: Long-term survival after radiotherapy alone: radiation therapy oncology group prostate cancer trials. J Urol 161 (3): 864-8, 1999.[PUBMED Abstract]

Valicenti R, Lu JD, Grignon D, et al.: Radiation dose-response is Gleason score dependent on the Radiation Therapy Oncology Group prostate cancer trials. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A1194, 311a, 1999.

Roach M, Lu J, Pilepich M, et al.: Long term survival in 1500 men treated for prostate cancer with radiotherapy alone (XRT): based on radiation therapy oncology group protocols 7706, 7506, 8531, and 8610. [Abstract] Proceedings of the American Urological Association 1998.

Roach M III, Lu J, Pilepich MV, et al.: Prognostic subgroups predict disease specific survival for men treated with radiotherapy alone on Radiation Therapy Oncology Group (RTOG) prostate cancer trials. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A1201, 312a, 1998.

Zhou R, Sause WT, Hammond EH, et al.: Correlation of survival with quantitative tissue staining of prostate specific acid phosphatase in patients with prostate carcinoma by using microscopic image analysis: a preliminary report of correlative studies on RTOG protocols 75-06, 77-06, and 83-07. Int J Radiat Oncol Biol Phys 33 (4): 823-9, 1995.[PUBMED Abstract]

Hanks GE, Krall JM, Hanlon AL, et al.: Patterns of Care and RTOG studies in prostate cancer: long-term survival, hazard rate observations, and possibilities of cure. Int J Radiat Oncol Biol Phys 28 (1): 39-45, 1994.[PUBMED Abstract]

Hammond ME, Sause WT, Martz KL, et al.: Correlation of prostate-specific acid phosphatase and prostate-specific antigen immunocytochemistry with survival in prostate carcinoma. Cancer 63 (3): 461-6, 1989.[PUBMED Abstract]

Pilepich MV, Asbell SO, Mulholland GS, et al.: Surgical staging in carcinoma of the prostate: the RTOG experience. Radiation Therapy Oncology Group. Prostate 5 (5): 471-6, 1984.[PUBMED Abstract]

Pilepich MV, Pajak T, George FW, et al.: Preliminary report on phase III RTOG studies of extended-field irradiation in carcinoma of the prostate. Am J Clin Oncol 6 (4): 485-91, 1983.[PUBMED Abstract]

Terry R: Some questions raised by histologic study of RTOG protocols 75-06 and 77-06 as illustrated by selected samples. Prostate 3 (6): 543-54, 1982.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

James Cox, MD, Protocol chair
Ph: 713-563-2316; 800-392-1611

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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