Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
258

Summary

Conditions
Non -Small Cell Lung Cancer
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Surgery versus SAbRMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 99 years
Gender
Both males and females

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 improv...

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.

Tracking Information

NCT #
NCT02468024
Collaborators
Not Provided
Investigators
Principal Investigator: Robert Timmerman, MD UTSW Medical Center