Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer
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.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Phase III Randomized Study of Radiotherapy to the Prostate With or Without Radiotherapy to the Pelvis in Patients With Stage I, II, or III Adenocarcinoma of the Prostate|
|Study Start Date:||December 1997|
|Study Completion Date:||January 2015|
|Primary Completion Date:||December 2002 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003607
|Centre Paul Papin|
|Angers, France, 49036|
|Centre Hospitalier d'Annecy|
|Annecy, France, 74011 Cedex|
|Bordeaux, France, 33076|
|Centre Regional Francois Baclesse|
|Caen, France, 14076|
|Centre de Radiotherapie du Parc|
|Chalon Sur Saone, France, 71100|
|Centre Hospitalier Universitaire Henri Mondor|
|Creteil, France, 94010|
|Centre Oscar Lambret|
|Lille, France, 59020|
|Centre Hospital Regional Universitaire de Limoges|
|Limoges, France, 87042|
|Clinique de la Sauvegarde - Clinique Jeanne D'Arc|
|Lyon, France, 69008|
|Clinique de la Sauvegarde|
|Lyon, France, 69008|
|Centre Leon Berard|
|Lyon, France, 69373|
|Institut J. Paoli and I. Calmettes|
|Marseille, France, 13273|
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|CHR D'Orleans - Hopital de la Source|
|Orleans, France, 45067|
|Hopital d'Instruction des Armees du Val de Grace|
|Centre Hospitalier Lyon Sud|
|Pierre Benite, France, 69495|
|Institut Jean Godinot|
|Reims, France, 51056|
|Centre Eugene Marquis|
|Rennes, France, 35064|
|Roanne, France, F-42300|
|Clinique de l'Orangerie|
|Strasbourg, France, 67010|
|Centre Paul Strauss|
|Strasbourg, France, 67085|
|Institut Claudius Regaud|
|Toulouse, France, 31052|
|Centre Marie Curie|
|Valance, France, 26000|
|Study Chair:||Pascal Pommier, MD||Centre Leon Berard|