An Alternative Radiation Fractionation Strategy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
I. To test the safety and tolerability of an alternative fractionation regimen in locally
advanced non-small cell lung cancer (NSCLC), consisting of 44 Gy with concurrent
chemotherapy followed by a stereotactic body radiation therapy (SBRT) boost to remaining
parenchymal and nodal disease. The maximum tolerated dose of the SBRT boost will be
I. To assess local control. II. To assess distant metastasis and patterns of failure. III.
To assess overall survival at 1 and 2 years.
OUTLINE: This is a dose-escalation study of radiation therapy and SBRT.
Patients undergo radiation therapy daily and receive carboplatin and paclitaxel weekly for
4.5 weeks. Patients then undergo 2 boost SBRT treatments 2-3 days apart.
After completion of study treatment, patients are followed up for 5 years.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) defined to be the dose level that results in a probability equal to 0.33 that a dose limiting toxicity (DLT) will be manifest using Common Terminology Criteria for Adverse Events (CTCAE) version 4 (v.4)
Up to 1 year
United States: Food and Drug Administration
|Emory University||Atlanta, Georgia 30322|