Lung Cancer Clinical Trial
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
Verified date | February 2018 |
Source | Radiation Therapy Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 81 |
Est. completion date | December 2016 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 procainamide |
Country | Name | City | State |
---|---|---|---|
United States | Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan |
United States | Saint Anthony's Hospital at Saint Anthony's Health Center | Alton | Illinois |
United States | Saint John's Cancer Center at Saint John's Medical Center | Anderson | Indiana |
United States | Mission Hospitals - Memorial Campus | Asheville | North Carolina |
United States | University of Colorado Cancer Center at UC Health Sciences Center | Aurora | Colorado |
United States | Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland |
United States | Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Birmingham | Alabama |
United States | Cancer Treatment Center for Southern Kentucky | Bowling Green | Kentucky |
United States | Wood County Oncology Center | Bowling Green | Ohio |
United States | New York Methodist Hospital | Brooklyn | New York |
United States | SUNY Downstate Medical Center | Brooklyn | New York |
United States | Providence Saint Joseph Medical Center - Burbank | Burbank | California |
United States | Saint Francis Medical Center | Cape Girardeau | Missouri |
United States | Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Cape Girardeau | Missouri |
United States | Adena Regional Medical Center | Chillicothe | Ohio |
United States | CCOP - Columbus | Columbus | Ohio |
United States | Doctors Hospital at Ohio Health | Columbus | Ohio |
United States | Grant Medical Center Cancer Care | Columbus | Ohio |
United States | Mount Carmel Health - West Hospital | Columbus | Ohio |
United States | Riverside Methodist Hospital Cancer Care | Columbus | Ohio |
United States | Grady Memorial Hospital | Delaware | Ohio |
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 | Fredericksburg Oncology, Incorporated | Fredericksburg | Virginia |
United States | Fremont Memorial Hospital | Fremont | Ohio |
United States | University of Florida Shands Cancer Center | Gainesville | Florida |
United States | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina |
United States | Wayne Radiation Oncology | Goldsboro | North Carolina |
United States | CCOP - Greenville | Greenville | South Carolina |
United States | Methodist Cancer Center at Methodist Hospital | Indianapolis | Indiana |
United States | Borgess Medical Center | Kalamazoo | Michigan |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville | Michigan |
United States | Fairfield Medical Center | Lancaster | Ohio |
United States | Central Maine Comprehensive Cancer Center at Central Maine Medical Center | Lewiston | Maine |
United States | Central Baptist Hospital | Lexington | Kentucky |
United States | Lima Memorial Hospital | Lima | Ohio |
United States | Veterans Affairs Medical Center - Long Beach | Long Beach | California |
United States | Monmouth Medical Center | Long Branch | New Jersey |
United States | Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio |
United States | Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton | New Jersey |
United States | Northwest Ohio Oncology Center | Maumee | Ohio |
United States | St. Luke's Hospital | Maumee | Ohio |
United States | Columbia Saint Mary's Hospital - Ozaukee | Mequon | Wisconsin |
United States | Baptist-South Miami Regional Cancer Program | Miami | Florida |
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 | Trinity CancerCare Center | Minot | North Dakota |
United States | Mobile Infirmary Medical Center | Mobile | Alabama |
United States | Community Cancer Center of Monroe | Monroe | Michigan |
United States | Mercy Memorial Hospital - Monroe | Monroe | Michigan |
United States | Good Samaritan Regional Health Center | Mount Vernon | Illinois |
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 | Regional Cancer Center at Singing River Hospital | Pascagoula | Mississippi |
United States | Arizona Oncology Services Foundation | Phoenix | Arizona |
United States | Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center | Plattsburgh | New York |
United States | Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center | Pomona | California |
United States | All Saints Cancer Center at Wheaton Franciscan Healthcare | Racine | Wisconsin |
United States | Cancer Centers of North Carolina - Raleigh | Raleigh | North Carolina |
United States | Rex Cancer Center at Rex Hospital | Raleigh | North Carolina |
United States | Rapid City Regional Hospital | Rapid City | South Dakota |
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 | William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan |
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 | Firelands Regional Medical Center | Sandusky | Ohio |
United States | North Coast Cancer Care, Incorporated | Sandusky | Ohio |
United States | Community Hospital of Springfield and Clark County | Springfield | Ohio |
United States | Mercy Medical Center | Springfield | Ohio |
United States | Flower Hospital Cancer Center | Sylvania | Ohio |
United States | Mercy Hospital of Tiffin | Tiffin | Ohio |
United States | CCOP - Toledo Community Hospital | Toledo | Ohio |
United States | Medical University of Ohio Cancer Center | Toledo | Ohio |
United States | St. Vincent Mercy Medical Center | Toledo | Ohio |
United States | Toledo Clinic, Incorporated - Main Clinic | Toledo | Ohio |
United States | Toledo Hospital | Toledo | Ohio |
United States | J. Phillip Citta Regional Cancer Center at Community Medical Center | Toms River | New Jersey |
United States | General Robert Huyser Cancer Center at David Grant Medical Center | Travis Air Force Base | California |
United States | Fulton County Health Center | Wauseon | Ohio |
United States | West Allis Memorial Hospital | West Allis | Wisconsin |
United States | Mount Carmel St. Ann's Cancer Center | Westerville | Ohio |
United States | Wilmed Radiation Oncology Services | Wilson | North Carolina |
United States | Genesis - Good Samaritan Hospital | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
Radiation Therapy Oncology Group | National Cancer Institute (NCI), NRG Oncology |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Therapy-induced Lung Toxicity | 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. | Once all patients have been followed for at least 12 months | |
Secondary | Correlation of Lung Toxicities With Biochemical Markers | Biomarker data will not be generated from these tissue specimens, therefore this analysis will not take place. | Once all patients have been followed for at least 12 months | |
Secondary | 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) | 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. | Baseline to 18 months post treatment | |
Secondary | Persistence of Pulmonary Toxicity at 2 Years After 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. | 2 years from completion of study treatment |
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