NCT00002899

Adjuvant Radiation Therapy in Treating Patients With Brain Metastases

Phase III Trial on Convergent Beam Irradiation of Cerebral Metastases

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Cancer

Interventions

Type	Name	Description
PROCEDURE	adjuvant therapy
RADIATION	radiation therapy
RADIATION	stereotactic radiosurgery

Timeline

• Start date: 1996-11-01
• Primary completion: 2007-11-01
• First posted: 2003-01-27
• Last updated: 2012-07-02

Locations

33 sites across 13 countries: Belgium, Finland, France, Germany, Israel, Italy, Latvia, Netherlands, Portugal, Spain, Switzerland, Turkey (Türkiye), United Kingdom