Spots Global Cancer Trial Database for Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
Official Title: A Randomized Phase II Study Comparing 2 Stereotactic Body Radiation Therapy (SBRT) Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer
Study ID: NCT00960999
Conditions
Study Description
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which regimen of stereotactic body radiation therapy is more effective in treating patients with non-small cell lung cancer. PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy regimens and to see how well they work in treating patients with stage I non-small cell lung cancer.
Detailed Description: OBJECTIVES: Primary * To determine the 1-year rate of ≥ grade 3 adverse events that are definitely, probably, or possibly related to treatment with single fraction vs multiple fraction stereotactic body radiotherapy in medically inoperable patients with stage I peripheral non-small cell lung cancer. Secondary * To estimate the 1-year primary tumor control rate in these patients. * To estimate the 1-year overall survival and disease-free survival rate of these patients. * To assess FDG-PET (fluorodeoxyglucose - positron emission tomography) standardized uptake value changes as a measure of treatment response and outcomes. * To determine pulmonary function changes by treatment arm and response. * To determine the association between biomarkers and primary tumor control and/or ≥ grade 2 radiation pneumonitis. OUTLINE: This is a multicenter study. Patients are stratified according to Zubrod performance status (0 vs 1 vs 2) and T stage (T1 vs T2). Patients are randomized to 1 of 2 treatment arms. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Auburn Radiation Oncology, Auburn, California, United States
Alta Bates Summit Comprehensive Cancer Center, Berkeley, California, United States
Radiation Oncology Centers - Cameron Park, Cameron Park, California, United States
Mercy Cancer Center at Mercy San Juan Medical Center, Carmichael, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
University of Colorado Cancer Center at UC Health Sciences Center, Aurora, Colorado, United States
Baptist Cancer Institute - Jacksonville, Jacksonville, Florida, United States
M.D. Anderson Cancer Center at Orlando, Orlando, Florida, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
Community Cancer Center, Normal, Illinois, United States
Advocate Lutheran General Cancer Care Center, Park Ridge, Illinois, United States
OSF St. Francis Medical Center, Peoria, Illinois, United States
Parkview Regional Cancer Center at Parkview Health, Fort Wayne, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Lucille P. Markey Cancer Center at University of Kentucky, Lexington, Kentucky, United States
James Graham Brown Cancer Center at University of Louisville, Louisville, Kentucky, 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
CCOP - Kansas City, Kansas City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, Saint Louis, Missouri, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
Stony Brook University Cancer Center, Stony Brook, New York, United States
Case Comprehensive Cancer Center, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Flower Hospital Cancer Center, Sylvania, Ohio, United States
Providence Cancer Center at Providence Portland Medical Center, Portland, Oregon, United States
Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania, United States
Dale and Frances Hughes Cancer Center at Pocono Medical Center, East Stroudsburg, Pennsylvania, United States
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
M. D. Anderson Cancer Center at University of Texas, Houston, Texas, United States
INOVA Alexandria Hospital, Alexandria, Virginia, United States
Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee, Milwaukee, Wisconsin, United States
Grand River Regional Cancer Centre at Grand River Hospital, Kitchener, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
McGill Cancer Centre at McGill University, Montreal, Quebec, Canada
Contact Details
Name: Gregory Videtic, MD
Affiliation: The Cleveland Clinic
Role: STUDY_CHAIR
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