Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT00449657
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
Study:
NCT00449657
Study Brief:
Protocol Section:
NCT00449657