Radiation Therapy to Prevent Brain Metastases in Patients With Previously Treated Extensive-Stage Small Cell Lung Cancer
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.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Prophylactic Cranial Irradiation In Extensive Disease Small Cell Lung Cancer|
- Time to symptomatic brain metastases measured by Logrank at 6 weeks, every 3 months in year 1, and then every 6 months [ Designated as safety issue: No ]
- Quality of life assessed by EORTC QLQ-C30 and EORTC BN-20 at baseline, 6 weeks, every 3 months in year 1, and then every 6 months [ Designated as safety issue: No ]
- Toxicity assessed by NCI CTC v2.0 during treatment, at 6 weeks, every 3 months in year 1, and then every 6 months [ Designated as safety issue: Yes ]
- Survival measured by Logrank at 6 weeks, every 3 months in year 1, and then every 6 months [ Designated as safety issue: No ]
|Study Start Date:||February 2001|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
- 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.
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|Study Chair:||B.J. Slotman, PhD, MD||Free University Medical Center|
|Study Chair:||Pieter E. Postmus, MD||Free University Medical Center|