NCT00016211

Radiation Therapy to Prevent Brain Metastases in Patients With Previously Treated Extensive-Stage Small Cell Lung Cancer

Prophylactic Cranial Irradiation In Extensive Disease Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 287 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy to the brain may be effective in preventing brain metastases. It is not yet known if radiation therapy is effective following chemotherapy in preventing brain metastases. PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in preventing brain metastases in patients who have received chemotherapy for extensive-stage small cell lung cancer.

Detailed description

OBJECTIVES: * Compare the incidence of, and time to, symptomatic brain metastases in patients with previously treated extensive stage small cell lung cancer treated with prophylactic cranial irradiation vs no further therapy. * Compare the quality of life and survival of these patients. * Determine the toxicity of this regimen in these patients. * Determine the health economics associated with this study. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and performance status. Patients are randomized to 1 of 2 treatment arms. * Arm I: Within 5 weeks after completion of prior chemotherapy, patients undergo prophylactic cranial irradiation once daily for 5-12 days. * Arm II: Patients receive no further therapy after completion of prior chemotherapy. Quality of life is assessed at baseline, 6 weeks, every 3 months for 1 year, and then every 6 months thereafter. Patients are followed at 6 weeks, every 3 months for 1 year, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 287 patients will be accrued for this study within 3 years.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
RADIATION	radiation therapy

Timeline

• Start date: 2001-02-01
• Primary completion: 2006-03-01
• First posted: 2003-01-27
• Last updated: 2012-09-24

Locations

49 sites across 12 countries: Belgium, Cyprus, Egypt, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Turkey (Türkiye), United Kingdom