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

Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial 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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00449657
Study type Interventional
Source Leo W. Jenkins Cancer Center
Contact
Status Terminated
Phase Phase 2
Start date February 2007
Completion date August 22, 2017
View Details
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