A Randomized Phase III Study of Sublobar Resection (+/- Brachytherapy) Versus Stereotactic Body Radiation Therapy in High Risk Patients With Stage I Non-Small Cell Lung Cancer (NSCLC)
- To ascertain whether patients treated by stereotactic body radiation therapy (SBRT)
have a 3-year overall survival (OS) rate that is no more than 10% less than patients
treated with sublobar resection (SR).
- To compare loco-regional recurrence-free survival between study arms.
- To compare disease-free survival between study arms.
- To compare grade 3 or higher specific adverse event profiles between study arms at 1,
3, 6, and 12 months post-therapy.
- To compare pulmonary function between patients treated with SBRT and patients treated
- To compare the adverse events and pulmonary function tests (PFTs) in each arm for
patients with low or high Charlson comorbidity index scores, including a test
interaction between Charlson comorbidity index scores (low vs high) and treatment arm.
- To compare the quality-adjusted survival between the SBRT and SR treatments in terms of
time to death (primary) and time until recurrence (secondary).
- To examine whether pre-operative and post-operative clinically significant deficits in
previously identified prognostic PRO domains (overall quality of life [QOL], fatigue,
anxiety, and dyspnea) are associated with shorter patient survival in this patient
population and to compare the relative effectiveness of each treatment (SBRT and SR).
- To contribute to an ACOSOG bank of normative data in order to improve short/long-term
outcomes of cancer patients by identifying patients experiencing clinically significant
deficits in patient-reported outcomes and the relationship to genetic variables.
- To explore whether blood-based biomarkers, including osteopontins, will be able to
predict which patients will be at high risk for recurrence by treatment with either
SBRT or SR. (exploratory)
- To explore whether blood-based biomarkers, including TGF-β1, will be able to predict
which patients will be at high risk for pulmonary complications by treatment with
either SBRT or SR. (exploratory)
OUTLINE: This is a multicenter study. Patients are stratified according to planned
brachytherapy (yes vs no) and ECOG performance status (0 vs 1 vs 2). Patients are randomized
to 1 of 2 treatment arms.
- Arm I: Patients undergo sublobar resection comprising either a wedge resection or
anatomical segmentectomy with or without intraoperative brachytherapy* comprising an
iodine I 125 implant at the resection margin.
- Arm II: Patients undergo 3 fractions of stereotactic body radiation therapy at 2-8 days
NOTE: *Patients may receive brachytherapy at the discretion of treating physician.
Patients may undergo blood sample collection at baseline and periodically during study for
correlative studies. Tumor tissue samples may also be collected from patients who undergo
Patients complete the Lung Cancer Symptom Scale (LCSS), the Linear Analogue Self-Assessment
(LASA), and the UCDS Shortness of Breath quality-of-life questionnaires at baseline and
periodically during study and follow-up.
After completion of study treatment, patients are followed up for 30 days, every 3 months
for 2 years, every 6 months for 1 year, and then yearly for 2 years.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
5-year OS rate
Hiran C. Fernando, MD
Boston Medical Center
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Mayo Clinic Scottsdale||Scottsdale, Arizona 85259|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|Charles M. Barrett Cancer Center at University Hospital||Cincinnati, Ohio 45267-0526|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|University of California Davis Cancer Center||Sacramento, California 95817|
|Swedish Cancer Institute at Swedish Medical Center - First Hill Campus||Seattle, Washington 98104|
|James Graham Brown Cancer Center at University of Louisville||Louisville, Kentucky 40202|
|Waukesha Memorial Hospital Regional Cancer Center||Waukesha, Wisconsin 53188|
|Winship Cancer Institute of Emory University||Atlanta, Georgia 30322|
|Stony Brook University Cancer Center||Stony Brook, New York 11794-8174|
|SUNY Upstate Medical University Hospital||Syracuse, New York 13210|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|Hollings Cancer Center at Medical University of South Carolina||Charleston, South Carolina 29425|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|
|James P. Wilmot Cancer Center at University of Rochester Medical Center||Rochester, New York 14642|
|Baptist Cancer Institute - Jacksonville||Jacksonville, Florida 32207|
|William Beaumont Hospital - Royal Oak Campus||Royal Oak, Michigan 48073|
|Greenebaum Cancer Center at University of Maryland Medical Center||Baltimore, Maryland 21201|
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|
|M.D. Anderson Cancer Center at Orlando||Orlando, Florida 32806|
|Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center||Savannah, Georgia 31403-3089|
|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|
|St. Luke's - Roosevelt Hospital Center - St.Luke's Division||New York, New York 10027|
|Geisinger Cancer Institute at Geisinger Health||Danville, Pennsylvania 17822-0001|
|Gundersen Lutheran Center for Cancer and Blood||La Crosse, Wisconsin 54601|
|University of Virginia Cancer Center||Charlottesville, Virginia 22908|
|OSF St. Francis Medical Center||Peoria, Illinois 61637|
|Providence Cancer Center at Providence Portland Medical Center||Portland, Oregon 97213-2967|
|DeCesaris Cancer Institute at Anne Arundel Medical Center||Annapolis, Maryland 21401|
|Mayo Clinic Hospital||Phoenix, Arizona 85054-4502|
|Allegheny Cancer Center at Allegheny General Hospital||Pittsburgh, Pennsylvania 15212|
|UAB Comprehensive Cancer Center||Birmingham, Alabama 35294|
|Stanford Cancer Center||Stanford, California 94305-5824|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center||Columbus, Ohio 43210-1240|
|York Cancer Center at Apple Hill Medical Center||York, Pennsylvania 17405|
|Sentara Cancer Institute at Sentara Norfolk General Hospital||Norfolk, Virginia 23507|
|Boston University Cancer Research Center||Boston, Massachusetts 02118|
|Valley Hospital - Ridgewood||Ridgewood, New Jersey 07450|
|Veterans Affairs Medical Center - Milwaukee||Milwaukee, Wisconsin 53295|
|Emory Crawford Long Hospital||Atlanta, Georgia 30308|
|Baylor University Medical Center - Dallas||Dallas, Texas 75246|
|St. Agnes Hospital Cancer Center||Baltimore, Maryland 21229|
|Tufts Medical Center Cancer Center||Boston, Massachusetts 02111|
|Providence Regional Cancer Partnership||Everett, Washington 98201|