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
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 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.
- Arm I (single fraction): Patients undergo one stereotactic body radiotherapy (SBRT)
treatment to the target lesion.
- Arm II (multiple fractions): Patients undergo SBRT to the target lesion once daily for
4 days.
Blood and tumor tissue samples may be collected for further analysis.
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.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
1-year rate of ≥ grade 3 adverse events that are definitely, probably, or possibly related to treatment
From start of treatment to 1 year
Yes
Gregory Videtic, MD
Study Chair
The Cleveland Clinic
United States: Federal Government
CDR0000652101
NCT00960999
November 2009
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
James Graham Brown Cancer Center at University of Louisville | Louisville, Kentucky 40202 |
Stony Brook University Cancer Center | Stony Brook, New York 11794-8174 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Baptist Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
M.D. Anderson Cancer Center at Orlando | Orlando, Florida 32806 |
Advocate Lutheran General Cancer Care Center | Park Ridge, Illinois 60068-1174 |
Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
Geisinger Cancer Institute at Geisinger Health | Danville, Pennsylvania 17822-0001 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Community Cancer Center | Normal, Illinois 61761 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Great Lakes Cancer Institute at McLaren Regional Medical Center | Flint, Michigan 48532 |
Alta Bates Summit Comprehensive Cancer Center | Berkeley, California 94704 |
Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Parkview Regional Cancer Center at Parkview Health | Fort Wayne, Indiana 46805 |
Dale and Frances Hughes Cancer Center at Pocono Medical Center | East Stroudsburg, Pennsylvania 18301 |
University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |
Veterans Affairs Medical Center - Milwaukee | Milwaukee, Wisconsin 53295 |
Auburn Radiation Oncology | Auburn, California 95603 |
Radiation Oncology Centers - Cameron Park | Cameron Park, California 95682 |
Inova Alexandria Hospital | Alexandria, Virginia 22304 |
Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael, California 95608 |