JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Procedure: Lung SurgeryRadiation: Radiation therapy
- Registration Number
- NCT02468024
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Brief Summary
To Determine if SAbR improves survival over SR in High Risk Operable Stage I NSCLC
- Detailed Description
Stereotactic Ablative Radiotherapy has been shown in single institution phase II and matched cohort studies to be effective at controlling primary early lung cancer. Recent pooled analysis of both the STARS and ROSEL randomized trials comparing SABR versus lobectomy have shown a significantly improved 3-year survival with SABR, giving further impetus for successful completion of a randomized trial .
Pre-randomized trial- Patients will be screened and pre-randomized to either SR or SAbR. Informed consent will be obtained after patients are made aware of the randomized assignment. Despite pre-randomization prior to consent, patients maintain their right to accept or decline any/all study activities. Only consenting patients will be allowed to participate in study activities, including observation after either randomized treatments or observation after standard of care treatment, while those declining consent will be managed by their physician(s) off study.Patients will be accrued and followed for a minimum of 2-years after treatment.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 272
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 lung surgery Lung Surgery Sublobar Resection (SR) Arm 2 radiation therapy Radiation therapy Stereotactic Ablative Radiotherapy (SAbR)
- Primary Outcome Measures
Name Time Method overall survival 3 years To test the hypothesis that the 3-year overall survival in high risk operable patients with Stage I NSCLC is greater in patient who undergo SAbR as compared to standard sublobar resection (SR).
- Secondary Outcome Measures
Name Time Method toxicity as assessed toxicity using the Common Toxicity Criteria 3 years toxicity using the Common Toxicity Criteria
progression free survival 5 years survival at 5-years for Stage I NSCLC who undergo SR or SAbR.
Trial Locations
- Locations (50)
St. Vincent's Hospital Melbourne
🇦🇺Fitzroy, Melbourne, Australia
Barwon Health - Uni Hospital Geelong
🇦🇺Geelong, Victoria, Australia
UCSD
🇺🇸La Jolla, California, United States
University of Colorado/Memorial
🇺🇸Aurora, Colorado, United States
Penrose Cancer Center
🇺🇸Colorado Springs, Colorado, United States
Boca Raton Regional Hospital
🇺🇸Boca Raton, Florida, United States
Curtis and Elizabeth Anderson Cancer
🇺🇸Savannah, Georgia, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
University of Kentucky Health Care
🇺🇸Lexington, Kentucky, United States
University of Louisville Physicians
🇺🇸Louisville, Kentucky, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
Luminis Health Research Institute
🇺🇸Annapolis, Maryland, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Beaumont
🇺🇸Royal Oak, Michigan, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Meridian Health System
🇺🇸Neptune, New Jersey, United States
New York University Langone Medical Center
🇺🇸New York, New York, United States
SUNY - Upsate Medical Centre
🇺🇸Syracuse, New York, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Case Western (University Hospitals Case Medical Center)
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Providence Health & Services/Oregon Clinic
🇺🇸Portland, Oregon, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
UPMC Health System
🇺🇸Pittsburgh, Pennsylvania, United States
Allegheny
🇺🇸Pittsburg, Pennsylvania, United States
Mount Nittany
🇺🇸State College, Pennsylvania, United States
Lifespan Oncology Clinical Research
🇺🇸Providence, Rhode Island, United States
University of Tennessee Health Science Center
🇺🇸Memphis, Tennessee, United States
Cardiothoracic and Vascular Surgeons
🇺🇸Austin, Texas, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Intermountain Medical Center
🇺🇸Salt Lake City, Utah, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Inova Fairfax Medical Campus
🇺🇸Falls Church, Virginia, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Clement Zablocki VA Medical Center
🇺🇸Milwaukee, Wisconsin, United States
St. Vincent's/Peter Mac
🇦🇺Fitzroy, Victoria, Australia
Lawson Health Science Center
🇨🇦London, Ontario, Canada, Canada
Ottawa Hospital Cancer Center
🇨🇦Ottawa, Ontario, Canada
UHN-Toronto
🇨🇦Toronto, Ontario, Canada
CHUM
🇨🇦Montréal, Quebec, Canada
Trillium Health Partners
🇨🇦Mississauga, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Canada
The James Cook University Hospital
🇬🇧Middlesbrough, United Kingdom