Lung Cancer Clinical Trial
Official title:
Prophylactic Cranial Irradiation In Extensive Disease 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.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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