A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients With Operable Stage I/II Non-Small Cell Lung Cancer
OBJECTIVES:
Primary
- Determine whether treatment with radiotherapy involving a high biological dose with
limited treatment volume (using stereotactic body radiotherapy [SBRT] techniques)
achieves acceptable primary tumor control (i.e., ≥ 90% at 2 years) in patients with
resectable early-stage non-small cell lung cancer.
Secondary
- Determine whether treatment with radiotherapy involving a high biological dose with
limited treatment volume (using SBRT techniques) achieves acceptable treatment-related
toxicity.
- Estimate the disease-free survival and the overall survival rate at 2 years.
- Observe patterns of failure in the first 2 years.
- Assess the level of comorbidity burden on morbidity and efficacy.
- Determine if blood markers prior to, during the course of treatment (between the second
and the last dose of SBRT), and at the first follow-up after SBRT predict 2-year
primary tumor control and predict for grade ≥ 2 treatment-related toxicities
OUTLINE: This is a multicenter study.
Patients receive 3 fractions of stereotactic body radiotherapy over 14 days. Patients with
disease progression undergo surgical resection as salvage local therapy.
After completion of study therapy, patients are followed every 3 months for 2 years, every 6
months for 3 years and then annually thereafter.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary tumor control at 2 years
From start of treatment to 2 years.
No
Robert D. Timmerman, MD
Principal Investigator
Simmons Cancer Center
United States: Federal Government
RTOG-0618
NCT00551369
December 2007
Name | Location |
---|---|
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
University of California Davis Cancer Center | Sacramento, California 95817 |
NYU Cancer Institute at New York University Medical Center | New York, New York 10016 |
Stony Brook University Cancer Center | Stony Brook, New York 11794-8174 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
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 |
Marin Cancer Institute at Marin General Hospital | Greenbrae, California 94904 |
UAB Comprehensive Cancer Center | Birmingham, Alabama 35294 |
Alta Bates Summit Comprehensive Cancer Center | Berkeley, California 94704 |
St. Joseph Cancer Center | Bellingham, Washington 98225 |
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Inova Alexandria Hospital | Alexandria, Virginia 22304 |
Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael, California 95608 |