This trial is active, not recruiting.

Conditions lung cancer, pulmonary complications, radiation fibrosis
Treatment captopril
Phase phase 2
Sponsor Radiation Therapy Oncology Group
Collaborator National Cancer Institute (NCI)
Start date June 2003
End date September 2008
Trial size 81 participants
Trial identifier NCT00077064, CDR0000315569, RTOG-0123, RTOG-L-0123


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
(No Intervention)
Clinical observation

Primary Outcomes

Incidence of therapy-induced lung toxicity
time frame: Once all patients have been followed for at least 12 months

Secondary Outcomes

Correlation of lung toxicities with biochemical markers
time frame: Once all patients have been followed for at least 12 months
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
Pulmonary toxicity at 2 years after completion of study treatment
time frame: 2 years from completion of study treatment

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - One of the following histologically or cytologically confirmed diagnoses: - Stage II-IIIB non-small cell lung cancer (NSCLC) - Stage I central NSCLC - No peripheral coin lesions - Limited stage small cell lung cancer - Nonmetastatic disease that is receiving radiotherapy and the target is confined to a single radiotherapy treatment area - Planning to receive radiotherapy - At least 45 Gy to be delivered to the target volume - More than 25% of total lung volume to receive > 20 Gy if receiving radiotherapy alone PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-1 Hematopoietic - Absolute granulocyte count greater than 1,000/mm^3 - Platelet count greater than 75,000/mm^3 - Hemoglobin greater than 9.0 g/dL (transfusion allowed) Hepatic - Bilirubin less than 1.5 mg/dL - Serum glutamate oxaloacetate transaminase (SGOT) less than 2 times normal Renal - Blood urea nitrogen (BUN) less than 25 mg/dL - Creatinine less than 1.6 mg/dL - Urine protein less than 10 mg/dL - Urine glucose negative Cardiovascular - Systolic blood pressure greater than 110 mm Hg - Diastolic blood pressure greater than 60 mm Hg Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Sodium normal - Potassium normal - No collagen vascular disease (e.g., lupus or scleroderma) - Rheumatoid arthritis allowed - No known hypersensitivity to ACE inhibitors PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Induction or concurrent chemotherapy allowed either during radiotherapy or during therapy with captopril - No concurrent methotrexate Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics Surgery - Prior pulmonary lobectomy or segmentectomy allowed - No prior pneumonectomy Other - No concurrent angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor antagonists for hypertension or congestive heart failure - No concurrent lithium - No concurrent procainamide

Additional Information

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
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Radiation Therapy Oncology Group.