Phase I/II Trial Evaluating Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Indiana University
- Enrollment
- 13
- Locations
- 3
- Primary Endpoint
- Rate of dose limiting toxicities (DLTs) in each cohort during Phase 1
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to test whether 5 fraction stereotactic ablative body radiation (SABR) is safe and improves local control for early state squamous cell carcinoma of the lung. While three fraction SABR is effective for the treatment of early stage non small cell lung carcinoma (NSCLC) of all histologies, it is not safe for many patients. While four and five fraction SABR is safe, recently published data and our institutional data suggests that local control for early stage squamous cell carcinoma of the lung using the current four or five fraction SABR is suboptimal.
Detailed Description
1. Primary Objectives During Phase I study - Determine the safety and maximum tolerated radiation dose for five fraction SABR for squamous cell cancer of the lung. During Phase II study - Determine 2 year local control of dose escalated five fraction SABR vs. institutional historical control standard dose SABR in squamous cell cancer of the lung. 2. Phase II Secondary Objectives * Determine overall survival, progression free survival and patterns of failure after SABR. * Determine tolerability of dose escalated SABR.
Investigators
Tim Lautenschlaeger
Assistant Professor of Radiation Oncology
Indiana University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Rate of dose limiting toxicities (DLTs) in each cohort during Phase 1
Time Frame: 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 Outcomes
- Local control during Phase 2(2 years)
- Overall survival(2 years)