Surgery With or Without Internal Radiation Therapy Compared With Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Stage I Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Procedure: therapeutic conventional surgeryRadiation: stereotactic body radiation therapyRadiation: iodine I 125
- Registration Number
- NCT01336894
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Surgery with or without internal radiation therapy may be an effective treatment for non-small cell lung cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known whether stereotactic body radiation therapy is more effective than surgery with or without internal radiation therapy in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying how well surgery with or without internal radiation therapy works compared with stereotactic body radiation therapy in treating patients with high-risk stage IA or stage IB non-small cell lung cancer.
- Detailed Description
OBJECTIVES:
Primary
* 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).
Secondary
* 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 with SR.
* 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.
Tertiary
* 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 apart.
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 resection.
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 13
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I (SR+Brachytherapy) iodine I 125 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 I (SR+Brachytherapy) therapeutic conventional surgery 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 (SBRT) stereotactic body radiation therapy Patients undergo 3 fractions of stereotactic body radiation therapy at 2-8 days apart.
- Primary Outcome Measures
Name Time Method 3-year Overall Survival (OS) Rate Up to 3 years post-randomization Overall survival is defined as the time from randomization until death from any cause.
- Secondary Outcome Measures
Name Time Method Loco-regional Recurrence-free Survival Up to 5 years post-randomization Loco-regional recurrence is defined as recurrence within the same lobe or hilum (N1 nodes), or within 2 cm of the staple line or within 2 cm of the PTV after treatment effects such as scarring have subsided.
Adverse Event Profiles at 12 Months Post-therapy 12 months post-therapy Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0.
Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.Disease-free Survival Up to 5 years post-randomization Disease free survival is defined as the time from randomization until documented disease recurrence or death, whichever occurs first. Patient who are disease free and alive at the time of analysis will be censored at the time of their last follow up.
Adverse Event Profiles at 1 Month Post-therapy 1 month post-therapy Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0.
Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.Adverse Event Profiles at 3 Months Post-therapy 3 months post-therapy Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0.
Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.Pulmonary Function Test Values Up to 12 months post-therapy Pulmonary function test values include forced expiratory volume 1 (FEV1), carbon monoxide diffusion (DLCO) and forced vital capacity (FVC).
Trial Locations
- Locations (53)
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Tufts Medical Center Cancer Center
🇺🇸Boston, Massachusetts, United States
William Beaumont Hospital - Royal Oak Campus
🇺🇸Royal Oak, Michigan, United States
Stony Brook University Cancer Center
🇺🇸Stony Brook, New York, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny Cancer Center at Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
Waukesha Memorial Hospital Regional Cancer Center
🇺🇸Waukesha, Wisconsin, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Baptist Cancer Institute - Jacksonville
🇺🇸Jacksonville, Florida, United States
M.D. Anderson Cancer Center at Orlando
🇺🇸Orlando, Florida, United States
Stanford Cancer Center
🇺🇸Stanford, California, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
Lucille P. Markey Cancer Center at University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
James Graham Brown Cancer Center at University of Louisville
🇺🇸Louisville, Kentucky, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
DeCesaris Cancer Institute at Anne Arundel Medical Center
🇺🇸Annapolis, Maryland, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
St. Agnes Hospital Cancer Center
🇺🇸Baltimore, Maryland, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
🇺🇸Saint Louis, Missouri, United States
St. Luke's - Roosevelt Hospital Center - St.Luke's Division
🇺🇸New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Geisinger Cancer Institute at Geisinger Health
🇺🇸Danville, Pennsylvania, United States
York Cancer Center at Apple Hill Medical Center
🇺🇸York, Pennsylvania, United States
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States
Baylor University Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Providence Regional Cancer Partnership
🇺🇸Everett, Washington, United States
Sentara Cancer Institute at Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Gundersen Lutheran Center for Cancer and Blood
🇺🇸La Crosse, Wisconsin, United States
London Regional Cancer Program at London Health Sciences Centre
🇨🇦London, Ontario, Canada
Ottawa Hospital Regional Cancer Centre - General Campus
🇨🇦Ottawa, Ontario, Canada
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
UAB Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Mayo Clinic Hospital
🇺🇸Phoenix, Arizona, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Providence Cancer Center at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Medical College of Wisconsin Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee
🇺🇸Milwaukee, Wisconsin, United States
Emory Crawford Long Hospital
🇺🇸Atlanta, Georgia, United States
Boston University Cancer Research Center
🇺🇸Boston, Massachusetts, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Valley Hospital - Ridgewood
🇺🇸Ridgewood, New Jersey, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Hopital Notre-Dame du CHUM
🇨🇦Montreal, Quebec, Canada