Radiation Therapy in Treating Patients Receiving Hormone Therapy for Prostate Cancer (GETUG-AFU 18)
- Conditions
- Prostate Cancer
- Interventions
- Radiation: 3-dimensional conformal radiation therapyRadiation: intensity-modulated radiation therapy
- Registration Number
- NCT00967863
- Lead Sponsor
- UNICANCER
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating patients with prostate cancer.
PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens in treating patients with prostate cancer receiving hormone therapy.
- Detailed Description
OBJECTIVES:
Primary
* Assess the impact of increasing the radiation dose 10 Gy on biochemical or clinical progression-free survival at 5 years in patients with unfavorable-risk prostate cancer receiving prolonged hormone therapy.
Secondary
* Evaluate overall and specific survival.
* Assess acute and late toxicities of different modalities (conformal or intensity-modulated radiotherapy).
* Evaluate toxicities of the different doses with respect to hormonal therapy.
* Assess the quality of life (QLQ-C30 and PR 25).
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo 80 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
* Arm II: Patients undergo 70 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
In both arms, patients receive goserelin subcutaneously once every 3 months for up to 3 years.
After completion of study treatment, patients are followed up periodically for 10 years.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm II 3-dimensional conformal radiation therapy Patients undergo 70 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks. Arm I 3-dimensional conformal radiation therapy Patients undergo 80 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks. Arm I intensity-modulated radiation therapy Patients undergo 80 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks. Arm II intensity-modulated radiation therapy Patients undergo 70 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
- Primary Outcome Measures
Name Time Method Biochemical or clinical progression-free survival at 5 years 5 years
- Secondary Outcome Measures
Name Time Method Acute and late toxicity 10 years Quality of life as measured by QLQ-C30 and PR 25 questionnaires 10 years Overall and specific survival 10 years
Trial Locations
- Locations (25)
Centre Léon Bérard
🇫🇷Lyon, France
Centre hospitalier Métropole Savoie
🇫🇷Chambéry, France
Clinique PASTEUR
🇫🇷Toulouse, France
Centre de Cancérologie du Grand Montpellier
🇫🇷Montpellier, France
Centre Azureen de Cancerologie
🇫🇷Mougins, France
Hia Begin
🇫🇷Saint-Mandé, France
Hôpital Saint Louis
🇫🇷Paris, France
Centre Henri Becquerel
🇫🇷Rouen, France
CHU Henri Mondor
🇫🇷Créteil, France
Institut de Cancérologie LUCIEN NEUWIRTH
🇫🇷Saint-Priest-en-Jarez, France
Centre Val D'Aurelle
🇫🇷Montpellier, France
Centre Eugène Marquis
🇫🇷Rennes, France
Clinique Léonard de Vinci
🇫🇷Chambray-lès-Tours, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Centre Rene Gauducheau
🇫🇷Saint-Herblain, France
Institut de Cancérologie de l'Ouest Paul Papin
🇫🇷Angers, France
Institut Bergonie
🇫🇷Bordeaux, France
Centre Francois Baclesse
🇫🇷Caen, France
Chr Orleans
🇫🇷Orléans, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre-Bénite, France
Centre CARIO - HPCA
🇫🇷Plérin, France
Hôpital Jean Bernard - CHU de Poitiers
🇫🇷Poitiers, France
Hopital La Timone
🇫🇷Marseille, France
Ch Bretonneau
🇫🇷Tours, France
Centre Alexis Vautrin
🇫🇷Vandœuvre-lès-Nancy, France