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| Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00077064 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer Pulmonary Complications Radiation Fibrosis |
Drug: captopril |
Phase II |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Active Control |
| 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 |
| Estimated Enrollment: | 205 |
| Study Start Date: | June 2003 |
OBJECTIVES:
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following histologically or cytologically confirmed diagnoses:
Stage I central NSCLC
Limited stage small cell lung cancer
Planning to receive radiotherapy
PATIENT CHARACTERISTICS:
Age
Performance status
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
No collagen vascular disease (e.g., lupus or scleroderma)
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Prior pulmonary lobectomy or segmentectomy allowed
Other
Contacts and Locations
Show 87 Study Locations| Study Chair: | William Small, MD | Robert H. Lurie Cancer Center |
More Information
| Study ID Numbers: | CDR0000315569, RTOG-0123, RTOG-L-0123 |
| Study First Received: | February 10, 2004 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00077064 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Thoracic Neoplasms Carcinoma, Neuroendocrine Fibrosis Disorders of Environmental Origin Respiratory Tract Diseases Lung Neoplasms Neoplasms, Germ Cell and Embryonal Neuroepithelioma Angiotensin-Converting Enzyme Inhibitors Captopril Lung Diseases, Interstitial Wounds and Injuries Cardiovascular Agents Antihypertensive Agents |
Neuroendocrine Tumors Carcinoma Protease Inhibitors Carcinoma, Small Cell Neuroectodermal Tumors Lung Diseases Non-small Cell Lung Cancer Radiation Pneumonitis Adenocarcinoma Carcinoma, Non-Small-Cell Lung Pneumonia Radiation Injuries Neoplasms, Glandular and Epithelial |
|
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Carcinoma, Neuroendocrine Fibrosis Neoplasms, Nerve Tissue Disorders of Environmental Origin Neoplasms by Site Pathologic Processes Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Angiotensin-Converting Enzyme Inhibitors Captopril Respiratory Tract Neoplasms |
Lung Diseases, Interstitial Neoplasms by Histologic Type Wounds and Injuries Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors Neoplasms Lung Diseases Radiation Pneumonitis |