Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to unmet accrual/randomization goals
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Pulmonary Complications | — | UNRESOLVED | — |
| Radiation Fibrosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| captopril | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Observation
- description
- Clinical observation
- type
- EXPERIMENTAL
- label
- Captopril
- description
- Captopril
- interventionNames
- Drug: captopril
Primary outcomes (1)
- measure
- Incidence of Therapy-induced Lung Toxicity
- timeFrame
- Once all patients have been followed for at least 12 months
- description
- Incidence of Grade 2+ radiation-induced pulmonary toxicity within 1 year after completion of radiation. Assuming that the incidence of pulmonary toxicity would be 50%, based on Fisher's exact test with a one-sided significance level of 0.05,168 randomized patients would be required to have 80% statistical power to detect a 40% relative reduction (from 50% to 30%) in the incidence of pulmonary toxicity while receiving captopril. Assuming that 15% of cases would not continue to the randomization stage and 5% of patients would be found ineligible, the target sample size was 205 patients. Given the actual sample size, power would be 25% and therefore p-values were not reported.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 procainamideReferences
Publications (0)
Data not yet available