The purpose of this study is to evaluate the efficacy and toxicity stereotactic body radiation (SBRT) as consolidation following standard chemoradiation for patients with stage III non-small cell lung cancer.
This protocol will investigate the potential role of SBRT for patients with stage 3 NSCLC. Eligible patients will first have received standard 50.4 Gy chemoradiation. Patients entering the study will have the opportunity to receive SBRT as a noninvasive option as compared to surgical resection. For patients who are not surgical candidates, SBRT after 50.4 Gy chemoradiation represents a technique of radiation consolidation that may be more effective and less toxic than standard conventional fractionated radiation
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Dose Levels Dose per Fraction Total Dose 1 8 Gy 16 Gy
Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
memorial Hospital of Rhode island
Pawtucket, Rhode Island, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Early and Intermediate Toxicity for Dose Limiting Toxicity
Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Serious adverse events will be captured from the time the patient signs consent until 12 weeks after the last SBRT. DLTS: defined in protocol as: Dose limiting toxicities will be defined as grade 3 or greater treatment related pneumonitis, cardiac toxicity, bronchial injury or chest wall pain during or within 4 weeks of completion of SBRT.
Time frame: 3 months
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Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy