Phase II Trial of Pulsed Paclitaxel With Concurrent Radiotherapy, and Adjuvant Chemotherapy in Stage III Non-Small Cell Lung Cancer
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
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor response using RECIST criteria
12/31/2012
No
Paul Walker, MD
Principal Investigator
Brody School of Medicine at East Carolina University
United States: Institutional Review Board
LJCC 07-01
NCT00449657
February 2007
June 2015
Name | Location |
---|---|
Brody School of Medicine at East Carolina University | Greenville, North Carolina 27858 |