Docetaxel in Non Small Cell Lung Cancer (NSCLC)

Sanofi

Status and phase: Completed; Phase 2

Conditions: Lung Neoplasms

Treatments: Other: Docetaxel + gemcitabine + carboplatin + radiotherapy; Drug: Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00258739

TAX_ES1_209

Details and patient eligibility

About

Primary objective:

• To classify the 2 study groups, according to the tumoral response.

Secondary objectives:

• To evaluate the percentage of focused control per year.
• To calculate the time until progression.
• To evaluate the safety profile.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non small cell lung cancer confirmed by histology or by cytology.
• IIIB stage, except if existing pleural discharge, upper cava vein syndrome or supraclavicular affectation
• General stage 0-1 at the ECOG scale
• Loss of weight less than 5% in the 3 previous months from diagnose.
• Pulmonary function and gasometry results: FEV1 > 30% or 1 l, DLCO (diffusing capacity of the lung for carbon monoxide) > 30%, PCO2 < 45 mmHg and PO2 > 60 mmHg.
• Normal medullar function (hemoglobin > 11 g/dl, total WBC > 1,5 x 10^9/l, platelets > 100 x 10^9/l)
• Appropriate renal and hepatic functions
• CTScan
• Anticonceptive method
• Available laboratory test (maximum 1 month before)

Exclusion criteria

• Pleural discharge, upper cava vein syndrome or supraclavicular affectation.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

1

Experimental group

Description:

Concomitant radiotherapy and carboplatin-docetaxel followed by docetaxel-gemcitabine

Treatment:

Drug: Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine

2

Experimental group

Description:

docetaxel-gemcitabine followed by concomitant radiotherapy with carboplatin-docetaxel

Treatment:

Other: Docetaxel + gemcitabine + carboplatin + radiotherapy