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Phase II Trial of Pulsed Paclitaxel With Concurrent Thoracic Radiotherapy, and Adjuvant Gemcitabine and Carboplatin in Stage IIIA and IIIB Non-Small Cell Lung Cancer

2014-07-23 21:29:56 | BioPortfolio

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

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

Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Non Small Cell Lung Cancer

Intervention

Taxol (paclitaxel), Radiotherapy, Carboplatin, Gemcitabine

Location

Brody School of Medicine at East Carolina University
Greenville
North Carolina
United States
27834

Status

Recruiting

Source

Leo W. Jenkins Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:29:56-0400

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Medical and Biotech [MESH] Definitions

Genus of coniferous yew trees or shrubs, several species of which have medicinal uses. Notable is the Pacific yew, Taxus brevifolia, which is used to make the anti-neoplastic drug taxol (PACLITAXEL).

Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.

A form of highly malignant lung cancer that is composed of small ovoid cells (SMALL CELL CARCINOMA).

A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.

An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.

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