Captopril in Treating Patients With Non-Small Cell Lung Cancer or Limited-Stage Small Cell Lung Cancer That Has Been Previously Treated With Radiation Therapy With or Without Chemotherapy
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|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|
- Incidence of therapy-induced lung toxicity [ Time Frame: Once all patients have been followed for at least 12 months ] [ Designated as safety issue: Yes ]
- Correlation of lung toxicities with biochemical markers [ Time Frame: Once all patients have been followed for at least 12 months ] [ Designated as safety issue: No ]
- Correlation of quality of life with late effects as measured by European Organization for Research and Treatment of Cancer (EORTC) C-30 or LC-13 [ Time Frame: Baseline to 18 months post treatment ] [ Designated as safety issue: No ]
- Pulmonary toxicity at 2 years after completion of study treatment [ Time Frame: 2 years from completion of study treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2003|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
No Intervention: Clinical observation
- 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.