JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiation Therapy (SAbR) for Lung Cancer

Official Title

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

Summary:

To Determine if SAbR improves survival over SR in High Risk Operable Stage I NSCLC

Trial Description

Primary Outcome:

• overall survival

Secondary Outcome:

• progression free survival
• toxicity as assessed toxicity using the Common Toxicity Criteria

Stereotactic Ablative Radiation Therapy 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.

View this trial on ClinicalTrials.gov