JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer (STABLE-MATES)
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|ClinicalTrials.gov Identifier: NCT02468024|
Recruitment Status : Recruiting
First Posted : June 10, 2015
Last Update Posted : August 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Procedure: Lung Surgery Radiation: Radiation therapy||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||272 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Surgery versus SAbR|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||July 2015|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2024|
Active Comparator: Arm 1 lung surgery
Sublobar Resection (SR)
Procedure: Lung Surgery
Sublobar Lung Resection
Other Name: SR
Experimental: Arm 2 radiation therapy
Stereotactic Ablative Radiotherapy (SAbR)
Radiation: Radiation therapy
Stereotactic Ablative Radiotherapy, 54 Gy in 3 fractions
Other Name: SAbR
- overall survival [ Time Frame: 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).
- progression free survival [ Time Frame: 5 years ]survival at 5-years for Stage I NSCLC who undergo SR or SAbR.
- toxicity as assessed toxicity using the Common Toxicity Criteria [ Time Frame: 3 years ]toxicity using the Common Toxicity Criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468024
|Contact: Sarah Hardee, MS||214-645-8525||sarah.hardee@UTSouthwestern.edu|
|Contact: Kajal Desai, MSemail@example.com|
|Principal Investigator:||Robert Timmerman, MD||UTSW Medical Center|