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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00077064
Other study ID # RTOG-0123
Secondary ID CDR0000315569RTO
Status Terminated
Phase Phase 2
First received February 10, 2004
Last updated February 6, 2018
Start date June 2003
Est. completion date December 2016

Study information

Verified date February 2018
Source Radiation Therapy Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

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

Study Design


Intervention

Drug:
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).

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
Radiation Therapy Oncology Group National Cancer Institute (NCI), NRG Oncology

Country where clinical trial is conducted

United States, 

Outcome

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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