Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00003607|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 23, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: radiation therapy||Phase 3|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|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|
|Actual Primary Completion Date :||December 2002|
|Actual Study Completion Date :||January 2015|
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): 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|