Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy
Start Date
4/13/2017
Completion Date
3/31/2034
Summary
Patients with stage I non-small cell lung cancer have been historically treated with surgery whenever they are fit for an operation. However, an alternative treatment known as stereotactic radiotherapy now appears to offer an equally effective alternative. Doctors believe both are good treatments and are therefore conducting this study to determine if one may be possibly better than the other.
Detailed Description
The standard of care for stage I non-small cell lung cancer has historically been surgical resection in patients who are medically fit to tolerate an operation. Recent data now suggests that stereotactic radiotherapy may be a suitable alternative. This includes the results from a pooled analysis of two incomplete phase III studies that reported a 15% overall survival advantage with stereotactic radiotherapy at 3 years. While these data are promising, the median follow-up period was short, the results underpowered, and the findings were in contradiction to multiple retrospective studies that demonstrate the outcomes with surgery are likely equal or superior. Therefore, the herein trial aims to evaluate these two treatments in a prospective randomized fashion with a goal to compare the overall survival beyond 5 years. It has been designed to enroll patients who have a long life-expectancy, and are fit enough to tolerate an anatomic pulmonary resection with intraoperative lymph node sampling. This study is designed to open at Veterans Affairs medical centers with expertise in both treatments. The recruitment process includes shared decision making and multi-disciplinary evaluations with lung cancer specialists. Mandatory evaluations before randomization include tissue confirmation of NSCLC, staging with FDG-PET/CT, and biopsies of all hilar and/or mediastinal lymph nodes \>10mm that have a SUV \>2.5. Pre-randomization elective lymph node sampling is strongly encouraged, but not required. Following treatment, patients will be followed for a minimum of 5 years.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Stereotactic Radiotherapy
Anatomic Pulmonary Resection
Conditions
Locations
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California 90822
United States
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California 90073-1003
United States
Bay Pines VA Healthcare System, Pay Pines, FL
Bay Pines, Florida 33744-0000
United States
Miami VA Healthcare System, Miami, FL
Miami, Florida 33125
United States
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois 60141-3030
United States
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana 46202-2884
United States
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland 21201
United States
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts 02130-4817
United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan 48105-2303
United States
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota 55417-2309
United States
Durham VA Medical Center, Durham, NC
Durham, North Carolina 27705-3875
United States
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio 44106-1702
United States
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania 19104-4551
United States
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania 15240
United States
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas 77030-4211
United States
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia 23249
United States
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin 53295-0001
United States