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
- Conditions
- Lung CancerPulmonary ComplicationsRadiation Fibrosis
- Interventions
- Registration Number
- NCT00077064
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 81
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Captopril captopril Captopril
- Primary Outcome Measures
Name Time Method Incidence of Therapy-induced Lung Toxicity Once all patients have been followed for at least 12 months 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.
- Secondary Outcome Measures
Name Time Method Correlation of Quality of Life With Late Effects as Measured by European Organization for Research and Treatment of Cancer (EORTC) C-30 or EORTC Lung Cancer Module (LC-13) Baseline to 18 months post treatment Only 2 patients have the required data- only 1.2% of the planned enrollment and 2.5% of the actual enrollment- which is extremely problematic as this data cannot be generalized, leads to selection bias, and is not representative of the patient population. Therefore the analysis was not conducted.
Correlation of Lung Toxicities With Biochemical Markers Once all patients have been followed for at least 12 months Biomarker data will not be generated from these tissue specimens, therefore this analysis will not take place.
Persistence of Pulmonary Toxicity at 2 Years After Completion of Study Treatment 2 years from completion of study treatment Patients who experienced a Grade 2+ radiation-induced pulmonary toxicity within 1 year after completion of radiation were assessed to determine if the toxicity persisted for 2 years.
Trial Locations
- Locations (87)
Mount Carmel Health - West Hospital
🇺🇸Columbus, Ohio, United States
Doctors Hospital at Ohio Health
🇺🇸Columbus, Ohio, United States
Great Lakes Cancer Institute at McLaren Regional Medical Center
🇺🇸Flint, Michigan, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
🇺🇸Marlton, New Jersey, United States
Methodist Cancer Center at Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
Providence Saint Joseph Medical Center - Burbank
🇺🇸Burbank, California, United States
Baptist-South Miami Regional Cancer Program
🇺🇸Miami, Florida, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
🇺🇸Lambertville, Michigan, United States
Regional Cancer Center at Singing River Hospital
🇺🇸Pascagoula, Mississippi, United States
Mission Hospitals - Memorial Campus
🇺🇸Asheville, North Carolina, United States
St. Charles Mercy Hospital
🇺🇸Oregon, Ohio, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Trinity CancerCare Center
🇺🇸Minot, North Dakota, 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
Veterans Affairs Medical Center - Long Beach
🇺🇸Long Beach, California, United States
Good Samaritan Regional Health Center
🇺🇸Mount Vernon, Illinois, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
🇺🇸Cape Girardeau, Missouri, United States
Saint John's Cancer Center at Saint John's Medical Center
🇺🇸Anderson, Indiana, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
🇺🇸Alton, Illinois, United States
Cancer Treatment Center for Southern Kentucky
🇺🇸Bowling Green, Kentucky, United States
Saint Francis Medical Center
🇺🇸Cape Girardeau, Missouri, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
🇺🇸Saint Louis, Missouri, United States
Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center
🇺🇸Plattsburgh, New York, United States
Cancer Centers of North Carolina - Raleigh
🇺🇸Raleigh, North Carolina, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Wayne Radiation Oncology
🇺🇸Goldsboro, North Carolina, United States
Wilmed Radiation Oncology Services
🇺🇸Wilson, North Carolina, United States
Rex Cancer Center at Rex Hospital
🇺🇸Raleigh, North Carolina, United States
Wood County Oncology Center
🇺🇸Bowling Green, Ohio, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Grant Medical Center Cancer Care
🇺🇸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
Northwest Ohio Oncology Center
🇺🇸Maumee, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
🇺🇸Marietta, Ohio, United States
St. Luke's Hospital
🇺🇸Maumee, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
🇺🇸Newark, 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
Fulton County Health Center
🇺🇸Wauseon, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
🇺🇸Toledo, Ohio, United States
Mount Carmel St. Ann's Cancer Center
🇺🇸Westerville, Ohio, United States
Fredericksburg Oncology, Incorporated
🇺🇸Fredericksburg, Virginia, United States
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
🇺🇸Birmingham, Alabama, United States
Arizona Oncology Services Foundation
🇺🇸Phoenix, Arizona, United States
University of Colorado Cancer Center at UC Health Sciences Center
🇺🇸Aurora, Colorado, 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
William Beaumont Hospital - Royal Oak Campus
🇺🇸Royal Oak, Michigan, United States
West Allis Memorial Hospital
🇺🇸West Allis, Wisconsin, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Hickman Cancer Center at Bixby Medical Center
🇺🇸Adrian, Michigan, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
Columbia Saint Mary's Hospital - Ozaukee
🇺🇸Mequon, Wisconsin, United States
University of Florida Shands Cancer Center
🇺🇸Gainesville, Florida, United States
Community Cancer Center of Monroe
🇺🇸Monroe, Michigan, United States
All Saints Cancer Center at Wheaton Franciscan Healthcare
🇺🇸Racine, Wisconsin, United States
Mercy Memorial Hospital - Monroe
🇺🇸Monroe, Michigan, United States
Highland Hospital of Rochester
🇺🇸Rochester, New York, United States
Medical University of Ohio Cancer Center
🇺🇸Toledo, Ohio, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
Genesis - Good Samaritan Hospital
🇺🇸Zanesville, Ohio, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
J. Phillip Citta Regional Cancer Center at Community Medical Center
🇺🇸Toms River, New Jersey, United States
Central Maine Comprehensive Cancer Center at Central Maine Medical Center
🇺🇸Lewiston, Maine, United States