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
NCT ID: NCT00077064
Last Updated: 2018-03-08
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
81 participants
INTERVENTIONAL
2003-06-30
2016-12-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Observation
Clinical observation
No interventions assigned to this group
Captopril
Captopril
captopril
Captopril 12.5 mg t.i.d. for first two weeks, increased to 25 mg t.i.d. for the second two weeks of therapy. Thereafter, the dose will be increased to 50 mg t.i.d. for the remainder of the one-year of therapy (52 total weeks of drug administration).
Interventions
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captopril
Captopril 12.5 mg t.i.d. for first two weeks, increased to 25 mg t.i.d. for the second two weeks of therapy. Thereafter, the dose will be increased to 50 mg t.i.d. for the remainder of the one-year of therapy (52 total weeks of drug administration).
Eligibility Criteria
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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 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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William Small, MD
Role: STUDY_CHAIR
Robert H. Lurie Cancer Center
Locations
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Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States
Mobile Infirmary Medical Center
Mobile, Alabama, United States
Arizona Oncology Services Foundation
Phoenix, Arizona, United States
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
Pomona, California, United States
General Robert Huyser Cancer Center at David Grant Medical Center
Travis Air Force Base, California, United States
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Saint John's Cancer Center at Saint John's Medical Center
Anderson, Indiana, United States
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, United States
Cancer Treatment Center for Southern Kentucky
Bowling Green, Kentucky, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Central Maine Comprehensive Cancer Center at Central Maine Medical Center
Lewiston, Maine, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
Great Lakes Cancer Institute at McLaren Regional Medical Center
Flint, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, United States
Community Cancer Center of Monroe
Monroe, Michigan, United States
Mercy Memorial Hospital - Monroe
Monroe, Michigan, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Cape Girardeau, Missouri, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States
J. Phillip Citta Regional Cancer Center at Community Medical Center
Toms River, New Jersey, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
New York Methodist Hospital
Brooklyn, New York, United States
Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, United States
Highland Hospital of Rochester
Rochester, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Wayne Radiation Oncology
Goldsboro, North Carolina, United States
Cancer Centers of North Carolina - Raleigh
Raleigh, North Carolina, United States
Rex Cancer Center at Rex Hospital
Raleigh, North Carolina, United States
Wilmed Radiation Oncology Services
Wilson, North Carolina, United States
Trinity CancerCare Center
Minot, North Dakota, United States
Wood County Oncology Center
Bowling Green, Ohio, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Grant Medical Center Cancer Care
Columbus, Ohio, United States
Mount Carmel Health - West Hospital
Columbus, Ohio, United States
Doctors Hospital at Ohio Health
Columbus, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Fremont Memorial Hospital
Fremont, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
Lima Memorial Hospital
Lima, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States
Northwest Ohio Oncology Center
Maumee, Ohio, United States
St. Luke's Hospital
Maumee, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States
St. Charles Mercy Hospital
Oregon, Ohio, United States
Toledo Clinic - Oregon
Oregon, Ohio, United States
Firelands Regional Medical Center
Sandusky, Ohio, United States
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States
Mercy Medical Center
Springfield, Ohio, United States
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States
Flower Hospital Cancer Center
Sylvania, Ohio, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, United States
Toledo Hospital
Toledo, Ohio, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, United States
Medical University of Ohio Cancer Center
Toledo, Ohio, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States
Fulton County Health Center
Wauseon, Ohio, United States
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States
CCOP - Greenville
Greenville, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, United States
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, United States
Columbia-Saint Mary's Cancer Care Center
Milwaukee, Wisconsin, United States
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, Wisconsin, United States
West Allis Memorial Hospital
West Allis, Wisconsin, United States
Countries
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Other Identifiers
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CDR0000315569
Identifier Type: -
Identifier Source: secondary_id
RTOG-L-0123
Identifier Type: -
Identifier Source: secondary_id
RTOG-0123
Identifier Type: -
Identifier Source: org_study_id
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