Radiation Therapy Compared With No Further Treatment Following Surgery in Treating Patients With Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00002511|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 16, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: low-LET photon therapy||Phase 3|
- 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.
PROJECTED ACCRUAL: A total of 1000 patients will be accrued for this study within 7.5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1005 participants|
|Official Title:||PHASE III STUDY OF POST-OPERATIVE EXTERNAL RADIOTHERAPY IN PATHOLOGICAL STAGE T3 N0 PROSTATIC CARCINOMA|
|Study Start Date :||December 1992|
|Primary Completion Date :||December 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002511
|Leuven, Belgium, B-3000|
|Study Chair:||Michel Bolla, MD||CHU de Grenoble - Hopital de la Tronche|
|Study Chair:||Hein van Poppel, MD, PhD||University Hospital, Gasthuisberg|