Prophylactic Cranial Irradiation In Extensive Disease Small Cell Lung Cancer
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Time to symptomatic brain metastases measured by Logrank at 6 weeks, every 3 months in year 1, and then every 6 months
No
B.J. Slotman, PhD, MD
Study Chair
Free University Medical Center
United States: Federal Government
EORTC-22993-08993
NCT00016211
February 2001
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