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Brief Title: Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer That Can Be Removed By Surgery
Official Title: 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
Study ID: NCT00551369
Brief Summary: RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue near the tumor. PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer that can be removed by surgery.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UAB Comprehensive Cancer Center, Birmingham, Alabama, United States
Alta Bates Summit Comprehensive Cancer Center, Berkeley, California, United States
Mercy Cancer Center at Mercy San Juan Medical Center, Carmichael, California, United States
Marin Cancer Institute at Marin General Hospital, Greenbrae, California, United States
University of California Davis Cancer Center, Sacramento, California, 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
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States
Lacks Cancer Center at Saint Mary's Health Care, Grand Rapids, Michigan, United States
William Beaumont Hospital - Royal Oak Campus, Royal Oak, Michigan, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, Saint Louis, Missouri, United States
NYU Cancer Institute at New York University Medical Center, New York, New York, United States
Stony Brook University Cancer Center, Stony Brook, New York, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States
INOVA Alexandria Hospital, Alexandria, Virginia, United States
St. Joseph Cancer Center, Bellingham, Washington, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Name: Robert D. Timmerman, MD
Affiliation: Simmons Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Elizabeth M. Gore, MD
Affiliation: Medical College of Wisconsin
Role: STUDY_CHAIR
Name: Harvey I. Pass, MD
Affiliation: NYU Langone Health
Role: STUDY_CHAIR
Name: Martin J. Edelman, MD
Affiliation: University of Maryland Greenebaum Cancer Center
Role: STUDY_CHAIR