Adjuvant Radiation Therapy in Treating Patients With Brain Metastases
- Conditions
- Metastatic Cancer
- Registration Number
- NCT00002899
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Adjuvant radiation therapy may kill any remaining tumor cells following surgery or radiosurgery for brain metastases.
PURPOSE: This randomized phase III trial is studying surgery or radiosurgery alone to see how well it works compared to surgery or radiosurgery and whole-brain radiation therapy in treating brain metastases in patients with solid tumors.
- Detailed Description
OBJECTIVES:
Primary
* Investigate the efficacy and toxicity of adjuvant whole brain radiotherapy after prior surgical resection or radiosurgery of 1 to 3 brain metastases from solid tumor in patients with good performance status and controlled systemic cancer.
Secondary
* Determine overall survival and progression-free survival of patients treated on this protocol.
* Determine time to neurologic progression in patients treated on this protocol.
* Determine quality of life of patients treated on this protocol.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating center, number of brain metastases (single vs multiple), type of primary tumor (stable systemic cancer vs synchronous or unknown primary), WHO performance status (0-1 vs 2), and treatment (prior surgical resection vs planned radiosurgery).
Patients who have undergone complete surgical resection are randomized to 1 of 2 treatment arms within 4 weeks after surgery.
* Arm I: Patients undergo adjuvant whole brain radiotherapy (WBRT).
* Arm II: Patients do not receive adjuvant radiotherapy. Patients planning to undergo radiosurgery are randomized to 1 of 2 treatment arms.
* Arm III: Patients undergo radiosurgery followed by adjuvant WBRT within 4 weeks after surgery.
* Arm IV: Patients undergo radiosurgery alone. Quality of life is assessed at baseline, at 8 weeks, and then every 3 months thereafter.
After completion if study treatment, patients are followed at 8 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 340 patients (85 per treatment arm) will be accrued for this study within 3.5 years.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 340
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival with a WHO performance status 0-2 as measured by Logrank at 8 weeks after completion of study treatment, and then every 3 months until death
- Secondary Outcome Measures
Name Time Method Overall survival as measured by Logrank at 8 weeks after completion of study treatment, and then every 3 months until death Progression-free survival as measured by Logrank 8 weeks after completion of study treatment, and then every 3 months until death Time to neurological progression as measured by Logrank 8 weeks after completion of study treatment, and then every 3 months until death Acute toxicity as measured by EORTC and RTOG scale 8 weeks after completion of study treatment, and then every 3 months until death Late toxicity as measured by Subjective, Objective, Management and Analytic/Late Effects on Normal Tissues (SOMA/LENT) scale 8 weeks after completion of study treatment, and then every 3 months until death Quality of life as measured by QLQ-C30 and BN-25 8 weeks after completion of study treatment, and then every 3 months until death
Trial Locations
- Locations (33)
Ospedale Niguarda Ca'Granda
🇮🇹Milan, Italy
Universita Degli Studi di Turin
🇮🇹Torino, Italy
Academisch Ziekenhuis der Vrije Universiteit Brussel
🇧🇪Brussels, Belgium
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
🇫🇷Besancon, France
Centre Hospitalier Regional et Universitaire de Lille
🇫🇷Lille, France
Helsinki University Central Hospital
🇫🇮Helsinki, Finland
Centre Leon Berard
🇫🇷Lyon, France
CHU Pitie-Salpetriere
🇫🇷Paris, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Medizinische Universitaetsklinik I at the University of Cologne
🇩🇪Cologne, Germany
Centre Haute Energie
🇫🇷Nice, France
Centre Eugene Marquis
🇫🇷Rennes, France
Medizinische Klinik und Poliklinik III - Universitaetsklinikum Leipzig
🇩🇪Leipzig, Germany
Heinrich-Braun-Krankenhaus Zwickau
🇩🇪Zwickau, Germany
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
Rambam Medical Center
🇮🇱Haifa, Israel
Istituto Nazionale Neurologico Carlo Besta
🇮🇹Milano, Italy
Azienda Sanitaria Ospedaliera Ordine Mauriziano
🇮🇹Torino, Italy
Ospedale Ostetrico Ginecologica Sant Anna
🇮🇹Torino, Italy
Maastro Clinic - Locatie Maastricht
🇳🇱Maastricht, Netherlands
Paula Stradina Kliniskas Universitates Slimnica
🇱🇻Riga, Latvia
Institut Catala d'Oncologia - Hospital Duran i Reynals
🇪🇸Barcelona, Spain
Hospital Santa Maria
🇵🇹Lisbon, Portugal
Marmara University Hospital
🇹🇷Istanbul, Turkey
Oncology Institute of Southern Switzerland
🇨ðŸ‡Bellinzona, Switzerland
University College Hospital - London
🇬🇧London, England, United Kingdom
Nottingham City Hospital NHS Trust
🇬🇧Nottingham, England, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Algemeen Ziekenhuis Sint-Augustinus
🇧🇪Wilrijk, Belgium
Royal Marsden NHS Foundation Trust - Surrey
🇬🇧Sutton, England, United Kingdom
Royal Preston Hospital
🇬🇧Preston, England, United Kingdom
Southend University Hospital NHS Foundation Trust
🇬🇧Westcliff-On-Sea, England, United Kingdom