NCT00002511CompletedPhase 3
PHASE III STUDY OF POST-OPERATIVE EXTERNAL RADIOTHERAPY IN PATHOLOGICAL STAGE T3 N0 PROSTATIC CARCINOMA
European Organisation for Research and Treatment of Cancer - EORTC2 sites in 1 country1,005 target enrollmentStarted: December 1992Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 1,005
- Locations
- 2
Study Overview
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for prostate cancer.
PURPOSE: Randomized phase III trial to compare radiation therapy with no further treatment in treating patients with stage III prostate cancer following radical prostatectomy.
Detailed Description
OBJECTIVES:
- Compare local recurrence rates, acute and late morbidity, overall survival, disease-free survival, and cancer-related survival of patients with pT3 pN0 adenocarcinoma of the prostate randomized following radical prostatectomy to postoperative conventional pelvic irradiation (60 Gy) vs no further treatment until relapse.
- Better define the selective pathologic indications for radiotherapy in patients with pT3 pN0 disease.
OUTLINE: This is a randomized study.
- Arm I: Patients undergo radiotherapy daily, 5 days a week, for 5 weeks, followed by boost radiotherapy for 1-1.4 weeks.
- Arm II: Patients are observed. Local relapse is treated with conventional pelvic radiotherapy.
Patients are followed every 3 months during the first postoperative year, every 6 months until the fifth year, and annually thereafter.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- — to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Investigators
Study Sites (2)
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