Spots Global Cancer Trial Database for Phase II Trial of Pulsed Taxol With Concurrent Thoracic Radiotherapy, & Adjuvant Chemo in Stage III NSCLC

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Trial Identification

Brief Title: Phase II Trial of Pulsed Taxol With Concurrent Thoracic Radiotherapy, & Adjuvant Chemo in Stage III NSCLC

Official Title: Phase II Trial of Pulsed Paclitaxel With Concurrent Radiotherapy,and Adjuvant Chemotherapy in Stage III Non-Small Cell Lung Cancer

Study ID: NCT00449657

Conditions

Non Small Cell Lung Cancer

Interventions

Study Description

Brief Summary: This is a phase II study to evaluate the toxicity and overall survival of pulsed paclitaxel with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage IIIA and IIIB non-small cell lung cancer

Detailed Description: OBJECTIVES Primary 1. Overall survival 2. Tumor response using RECIST criteria Secondary 1. Determine the toxicity of the proposed treatment in this patient population. 2. Progression free survival 3. Locoregional control 4. Distant failure STUDY DESIGN Description of the Study Phase II study to evaluate the toxicity and overall survival of pulsed paclitaxel with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage IIIA and IIIB non-small cell lung cancer. Rationale for Study Design The proposed doses of gemcitabine, carboplatin, paclitaxel, and thoracic radiation therapy have been previously studied and deemed safe. The design of this study is not to find the maximum tolerated dose (MTD) of these agents, but to study the toxicity and overall survival from this combination. Outcome Measures Primary Outcome Measures 1. Overall survival 2. Tumor response using RECIST criteria Secondary Outcome Measures 1. Locoregional control 2. Distant Failure 3. Progression free survival