NCT03321760

SABR for T1-2a N1 NSCLC

Phase II Evaluation With Safety Run-in of Stereotactic Ablative Body Radiation for T1-2a N1 Non-Small Cell Lung Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Conventionally fractionated radiation therapy given over 6-7 weeks alone, sequentially, or concurrent with chemotherapy have produced poor outcomes in Stage II NSCLC in most series. Stereotactic ablative radiotherapy (SABR) has been shown to be very effective and is now standard of care for Stage 1 disease. There has been initially reluctance to utilize SABR for central lung tumors because of published reports that showed an excess of toxicity when SABR was utilized; however, newer data with less intense treatment regimens suggest safety in treatment of central lung disease. The safety and efficacy of SABR in treating hilar nodes or N1 disease currently is not known fully and will be evaluated in this study.

Detailed description

1. Primary Objectives Safety run-in - To determine the safety of SABR for the treatment of primary lung disease and N1 (hilar) node in stage T1-2a N1 NSCLC Phase II - To determine 2-year local control of SABR for T1-2a N1 NSCLC with sequential chemotherapy 2. Secondary Objectives Phase II - To determine overall and progression-free survival times, pattern of failures, and rates of ≥ grade 3 adverse events after SABR for T1-2a N1 NSCLC combined with sequential chemotherapy

Conditions

• Lung Cancer

Interventions

Type	Name	Description
RADIATION	Stereotactic Ablative Radiation Therapy (SABR)	SABR will be delivered to the primary disease and hilar (N1) node over 5 fractions.Reductions may be made to the hilar (N1) node according to a 3+3 design during the run-in period.

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2017-10-26
• Last updated: 2022-02-09

Locations

3 sites across 1 country: United States