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Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for Early Stage, Centrally Located, Non-Small Cell Lung Cancer (NSCLC) in Medically Inoperable Patients

Primary Objective Phase I Portion To determine the maximal tolerated dose (MTD) of SBRT for centrally-located NSCLC and the efficacy of that dose in patients who are not operative candidates Phase II Portion (8/20/10) To estimate the primary tumor control rate at the MTD of SBRT Secondary Objectives (8/20/10) To estimate rates of greater than or equal to grade 3 CTCAE, v. 4 adverse events other than a dose-limiting toxicity (DLT) which is possibly, probably, or definitely related to treatment and which occurs within 1 year from the start of SBRT To estimate rates of late (greater than 1 year from start of SBRT) adverse events To estimate the primary tumor control and progression-free and overall survival rates for patients treated with this regimen Tertiary Objectives (Exploratory) [8/20/10] To study if molecular markers (proteomic or genomic) in the blood circulation prior to, during the course of treatment (between the third and fourth dose of SBRT), and at the first follow-up after SBRT predict 2-year primary tumor control, the occurrence of treatment-related grade greater than or equal to 2 pulmonary adverse events, or the occurrence of treatment-related grade greater than or equal to 2 non-pulmonary adverse events; data will be analyzed in conjunction with other lung SBRT studies, including operable and inoperable patients. To analyze the prognostic significance of comorbidity status; data will be analyzed in conjunction with other SBRT studies, including operable and inoperable patients To document tumor motion and inter-fraction (setup) errors.

Primary Objective Phase I Portion To determine the maximal tolerated dose (MTD) of SBRT for centrally-located NSCLC and the efficacy of that dose in patients who are not operative candidates Phase II Portion (8/20/10) To estimate the primary tumor control rate at the MTD of SBRT Secondary Objectives (8/20/10) To estimate rates of greater than or equal to grade 3 CTCAE, v. 4 adverse events other than a dose-limiting toxicity (DLT) which is possibly, probably, or definitely related to treatment and which occurs within 1 year from the start of SBRT To estimate rates of late (greater than 1 year from start of SBRT) adverse events To estimate the primary tumor control and progression-free and overall survival rates for patients treated with this regimen Tertiary Objectives (Exploratory) [8/20/10] To study if molecular markers (proteomic or genomic) in the blood circulation prior to, during the course of treatment (between the third and fourth dose of SBRT), and at the first follow-up after SBRT predict 2-year primary tumor control, the occurrence of treatment-related grade greater than or equal to 2 pulmonary adverse events, or the occurrence of treatment-related grade greater than or equal to 2 non-pulmonary adverse events; data will be analyzed in conjunction with other lung SBRT studies, including operable and inoperable patients. To analyze the prognostic significance of comorbidity status; data will be analyzed in conjunction with other SBRT studies, including operable and inoperable patients To document tumor motion and inter-fraction (setup) errors.