SABR for T1-2a N1 NSCLC

Phase 2

Withdrawn

Brief 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

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Run-In Dose 1	Stereotactic Ablative Radiation Therapy (SABR)	10 Gy dose delivered to the primary tumor \& 10 Gy to the hilar (N1) node over 5 fractions
Run-In Dose -1	Stereotactic Ablative Radiation Therapy (SABR)	10 Gy dose delivered to the primary tumor \& 9 Gy to the hilar (N1) node over 5 fractions
Phase 2	Stereotactic Ablative Radiation Therapy (SABR)	The maximum tolerated radiation dose to the hilar (N1) node from the run-in period will be used during Phase 2.
Run-In Dose -2	Stereotactic Ablative Radiation Therapy (SABR)	10 Gy dose delivered to the primary tumor \& 8 Gy to the hilar (N1) node over 5 fractions

Primary Outcome Measures

Name	Time	Method
Rate of dose-limiting toxicities (DLTs) during the run-in period	30 days	Any event per CTCAE v.4 that occurs within 30 days from the start of SABR, and is possibly, probably or definitely related to treatment, and is related to a specific list of symptoms which are outlined in the protocol.

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years	Length of time start of treatment that patients are still alive
Local control	2 years	Failure of disease progression within or immediately adjacent to the treatment planning target volume (PTV) of the lung primary and nodal disease. Failures will be classified as local failures if failing within or immediately adjacent to the N1 or primary tumor PTV, unless judged by the investigator team to convincingly be a separate lesion from the treated lesion (i.e. new lesion within PTV but across a fissure)
Progression free survival	2 years	Length of time during and after the treatment that a patient lives with the disease but it does not get worse
Rate of dose-limiting toxicities (DLTs) at one year	1 year	Any event per CTCAE v.4 that occurs within 1 year from the start of SABR, and is possibly, probably or definitely related to treatment, and is related to a specific list of symptoms which are outlined in the protocol.

Locations (3): Indiana University Health Methodist Hospital
🇺🇸
Indianapolis, Indiana, United States
Indiana University Health Hospital
🇺🇸
Indianapolis, Indiana, United States
Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, United States