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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

Phase 2
18 Years
Open (Enrolling)
Lung Cancer, Pulmonary Complications, Radiation Fibrosis

Thank you

Trial Information

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


- 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

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.

Inclusion Criteria


- 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



- 18 and over

Performance status

- Zubrod 0-1


- 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)


- Bilirubin less than 1.5 mg/dL

- SGOT less than 2 times normal


- BUN less than 25 mg/dL

- Creatinine less than 1.6 mg/dL

- Urine protein less than 10 mg/dL

- Urine glucose negative


- Systolic blood pressure greater than 110 mm Hg

- Diastolic blood pressure greater than 60 mm Hg


- 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


Biologic therapy

- Not specified


- Induction or concurrent chemotherapy allowed either during radiotherapy or during
therapy with captopril

- No concurrent methotrexate

Endocrine therapy

- Not specified


- See Disease Characteristics


- Prior pulmonary lobectomy or segmentectomy allowed

- No prior pneumonectomy


- No concurrent angiotensin-converting enzyme (ACE) inhibitors or angiotensin II
receptor antagonists for hypertension or congestive heart failure

- No concurrent lithium

- No concurrent procainamide

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Outcome Measure:

Incidence of therapy-induced lung toxicity

Principal Investigator

William Small, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Federal Government

Study ID:




Start Date:

June 2003

Completion Date:

Related Keywords:

  • Lung Cancer
  • Pulmonary Complications
  • Radiation Fibrosis
  • radiation fibrosis
  • pulmonary complications
  • limited stage small cell lung cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage I non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Fibrosis
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Radiation Pneumonitis



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