Comparison of Radiation Therapy Regimens in Treating Patients With Localized Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00010244
- Lead Sponsor
- UNICANCER
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy is more effective for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of radiation therapy in treating patients who have localized prostate cancer.
- Detailed Description
OBJECTIVES: I. Compare the 5-year survival rate, in terms of clinical and biological remission, in patients with localized prostate cancer treated with two different radiotherapy regimens using different doses and number of fractions. II. Compare the nadir of PSA and the delay in obtaining the nadir in patients treated with these two regimens. III. Compare acute and long-term toxicity of these two regimens in these patients. IV. Compare overall survival and quality of life in patients treated with these two regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive radiotherapy to the seminal vesicles at 46 Gy in 23 fractions and to the prostate at 70 Gy in 35 fractions, with 5 fractions per week. Arm II: Patients receive radiotherapy to the seminal vesicles as in arm I and to the prostate at 80 Gy in 40 fractions, with 5 fractions per week. Treatment continues in both arms in the absence of disease progression or unacceptable toxicity. Quality of life is assessed annually. Patients are followed every 4 months for a minimum of 5 years.
PROJECTED ACCRUAL: A total of 306 patients (153 per arm) will be accrued for this study within 2.5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 306
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Institut Curie - Section Medicale
🇫🇷Paris, France
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
🇫🇷Dijon, France
Centre Leon Berard
🇫🇷Lyon, France
Institut J. Paoli and I. Calmettes
🇫🇷Marseille, France
Hopital Notre-Dame de Bon Secours
🇫🇷Metz, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France
CRLCC Nantes - Atlantique
🇫🇷Nantes-Saint Herblain, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Hopital Jules Courmont - Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
CHU Pitie-Salpetriere
🇫🇷Paris, France
Institut Jean Godinot
🇫🇷Reims, France
Centre Eugene Marquis
🇫🇷Rennes, France
Centre Henri Becquerel
🇫🇷Rouen, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Centre Hospitalier Universitaire Bretonneau de Tours
🇫🇷Tours, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Hopital Saint Andre
🇫🇷Bordeaux, France
Hopital Jean Bernard
🇫🇷Poitiers, France