West Cancer Center

LUNG: Stage 1; Surgery vs. XRT; JOLT: \\\"STABLE-MATES\\\"

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

Title

UT Southwestern JOLT

Study Title

Site Link

NCT02468024

Malignancy

Lung cancer, Early lung cancer; NSCLC

Stage

Stage 1

Disease Setting

Curative

Line Of Therapy

Primary treatment

Investigational Agent

SR vs. SAbR

Drug Class

Surgery vs. XRT

Benny Weksler, MD

Sponsor

University of Texas Southwestern Medical Center

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

NCT02468024

Key Eligibility Criteria Details

Radiographic findings c/w and biopsy proven NSCLC
Tumor <4 cm maximum diameter (clinical stage IA and selected IB within 60 days of tx)
All clinically suspicious mediastinal nodes confirmed negative for cancer histologically
Tumor verified by thoracic surgeon to be in a location that will permit sublobar resection
Tumor must be peripheral (not touching any surface within 2 cm of proximal bronchial tree)
Patient must be at high risk for surgery by meeting 1 major or 2 minor criteria
No prior malignancy unless disease free for >3 years (except skin CA and in-situ disease)
No evidence of distant mets
No prior intrathoracic radiation therapy
ECOG PS 0-2

Objective

Primary- OS at 3 years: Secondary- PFS at 5 years, toxicity

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Non-small cell lung cancer

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes