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Spots Global Cancer Trial Database for JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer

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Trial Identification

Brief Title: JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer

Official Title: JoLT-Ca A Randomized Phase III Study of Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) in High Risk Patients With Stage I Non-Small Cell Lung Cancer (NSCLC), The STABLE-MATES Trial

Study ID: NCT02468024

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Allegheny, Pittsburgh, Pennsylvania, United States

UPMC Health System, Pittsburgh, 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

Contact Details

Name: Robert Timmerman, MD

Affiliation: UTSW Medical Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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