Lung Cancer Clinical Trial
Official title:
A Phase II Randomized Trial With Captopril In Patients Who Have Received Radiation Therapy +/- Chemotherapy For Stage II-IIIB Non-Small Cell Lung Cancer, Stage I Central Non-Small Cell Lung Cancer, Or Limited-Stage Small-Cell Lung Cancer
RATIONALE: Captopril is a drug that may be able to decrease side effects caused by radiation
therapy, and may improve the quality of life of patients with non-small cell lung cancer or
limited-stage small cell lung cancer.
PURPOSE: This randomized phase II trial is studying how well captopril works in decreasing
side effects and improving the quality of life in patients who have received radiation
therapy with or without chemotherapy for stage I, stage II, or stage IIIB non-small cell lung
cancer or limited-stage small cell lung cancer.
OBJECTIVES:
- Determine the effect of captopril on the incidence of pulmonary damage at 12 months
after radiotherapy with or without chemotherapy in patients with stage II-IIIB non-small
cell lung cancer, stage I central non-small cell lung cancer, or limited stage small
cell lung cancer.
- Compare the quality of life of patients treated with captopril vs patients who undergo
post-radiotherapy observation only.
- Determine the persistence of captopril's effect on pulmonary toxicity in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, total lung irradiated (< 25% vs 25-37% vs more than 37%), prior surgery
(yes vs no), and prior chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment
arms.
- Arm I: Patients receive oral captopril 3 times daily for 1 year in the absence of
disease progression or unacceptable toxicity.
- Arm II: Patients undergo observation only for 1 year. Quality of life is assessed at
baseline and at months 3, 6, 12, and 18.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 205 patients will be accrued for this study within 18 months.
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