Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer

Phase 3

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00003607
• Lead Sponsor: UNICANCER

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether radiation therapy to the prostate and pelvis is more effective than radiation therapy to the prostate alone in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the prostate with or without radiation to the pelvis in treating patients with stage I, stage II, or stage III prostate cancer.

Detailed Description

OBJECTIVES:

* Compare the survival without recurrence and overall survival of patients with stage I, II, or III adenocarcinoma of the prostate after receiving radiotherapy to the prostate with or without radiotherapy to the pelvis.

* Compare the toxic effects of these two regimens in these patients.

* Compare the quality of life of patients treated with these regimens.

* Determine the prognostic factors of progression in these patients.

* Analyze the site of relapse (prostate, pelvic lymph nodes, metastases) in case of progression in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating center and prognostic group (poor vs good prognosis).

Patients are randomized to one of two treatment arms.

* Arm I: Patients receive pelvic irradiation plus local prostate irradiation.

* Arm II: Patients receive local prostate irradiation only. Radiotherapy in both arms is administered 5 days a week for 7 weeks.

Quality of life is assessed before therapy, 12 months after therapy, and then annually thereafter.

Patients are followed at 2 and 6 months and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 4 years.

Study Timeline

• Study Start: 1997-12
• Study First Submitted: 1999-11-01
• Primary Completion: 2002-12
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Study Completion: 2015-01
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-22
• Last Update Posted: 2016-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 450

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (23)

Centre Paul Papin; 🇫🇷 Angers, France

Centre Hospitalier d'Annecy; 🇫🇷 Annecy, France

Institut Bergonie; 🇫🇷 Bordeaux, France

Centre Regional Francois Baclesse; 🇫🇷 Caen, France

Centre de Radiotherapie du Parc; 🇫🇷 Chalon Sur Saone, France

Centre Hospitalier Universitaire Henri Mondor; 🇫🇷 Creteil, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre Hospital Regional Universitaire de Limoges; 🇫🇷 Limoges, France

Clinique de la Sauvegarde - Clinique Jeanne D'Arc; 🇫🇷 Lyon, France

Clinique de la Sauvegarde; 🇫🇷 Lyon, France

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