Docetaxel in Non Small Cell Lung Cancer (NSCLC)

Phase 2

Completed

• Conditions: Lung Neoplasms
• Interventions: Drug: Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine; Other: Docetaxel + gemcitabine + carboplatin + radiotherapy

• Registration Number: NCT00258739
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-10
• Study First Submitted: 2005-11-23
• Study First Submitted QC: 2005-11-23
• Study First Posted: 2005-11-28
• Primary Completion: 2007-09
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-04
• Last Update Posted: 2009-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine	Concomitant radiotherapy and carboplatin-docetaxel followed by docetaxel-gemcitabine
2	Docetaxel + gemcitabine + carboplatin + radiotherapy	docetaxel-gemcitabine followed by concomitant radiotherapy with carboplatin-docetaxel

Primary Outcome Measures

Name	Time	Method
Response rate in each arm measured according to RECIST criteria	Throughout the whole study

Secondary Outcome Measures

Name	Time	Method
Percentage of local-regional control within a year	Throughout the first year
Time to progression defined as the period of time elapsed between the randomization date and the progression or death date	Throughout the whole study
Toxicity measured by CALGB criteria and RTOG/EORTC criteria	Throughout the whole study
Global surveillance measured as the period of time elapsed between randomization and death date.	Throughout the whole study duration

Trial Locations

Locations (1)

Sanofi-Aventis; 🇪🇸 Barcelona, Spain