Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Supportive care Closed 18 and over NCI RTOG-0123 RTOG-L-0123, NCT00077064

Objectives

1. 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.
2. Compare the quality of life of patients treated with captopril vs patients who undergo post-radiotherapy observation only.
3. Determine the persistence of captopril's effect on pulmonary toxicity in these patients.

Entry Criteria

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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Zubrod 0-1

Hematopoietic

• Absolute granulocyte count greater than 1,000/mm³
• Platelet count greater than 75,000/mm³
• Hemoglobin greater than 9.0 g/dL (transfusion allowed)

Hepatic

• Bilirubin less than 1.5 mg/dL
• SGOT less than 2 times normal

Renal

• 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

Expected Enrollment

A total of 205 patients will be accrued for this study within 18 months.

Outcomes

Incidence of therapy-induced lung toxicity
Correlation of lung toxicities with biochemical markers
Correlation of quality of life with late effects as measured by EORTC C-30 or LC-13
Pulmonary toxicity at 2 years after completion of study treatment

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.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

William Small, MD, Protocol chair		Ph: 312-926-6810 Email: w-small@northwestern.edu

Registry 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
Trial Start Date		2003-06-04
Registered in ClinicalTrials.gov		NCT00077064
Date Submitted to PDQ		2003-06-10
Information Last Verified		2007-09-07
NCI Grant/Contract Number		CA37422

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