Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
140 participants
INTERVENTIONAL
2001-10-31
Brief Summary
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* 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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Concomitant radiotherapy and carboplatin-docetaxel followed by docetaxel-gemcitabine
Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine
Docetaxel 20 mg/m²/week with carboplatin AUC 2/week and concomitant radiotherapy up to 60 Gy. Further on, 2 Docetaxel cycles and gemcitabine according to arm 2.
2
docetaxel-gemcitabine followed by concomitant radiotherapy with carboplatin-docetaxel
Docetaxel + gemcitabine + carboplatin + radiotherapy
Docetaxel 40 mg/ m² days 1, 8, 21 and 28 with gemcitabine 1200 mg/ m² days 1, 8, 21 and 28 followed by concomitant treatment with docetaxel 20 mg/m²/week with carboplatin AUC 2/week and concomitant radiotherapy up to 60 Gy (2 Gy/day, 5 days per week and for 6 weeks).
Interventions
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Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine
Docetaxel 20 mg/m²/week with carboplatin AUC 2/week and concomitant radiotherapy up to 60 Gy. Further on, 2 Docetaxel cycles and gemcitabine according to arm 2.
Docetaxel + gemcitabine + carboplatin + radiotherapy
Docetaxel 40 mg/ m² days 1, 8, 21 and 28 with gemcitabine 1200 mg/ m² days 1, 8, 21 and 28 followed by concomitant treatment with docetaxel 20 mg/m²/week with carboplatin AUC 2/week and concomitant radiotherapy up to 60 Gy (2 Gy/day, 5 days per week and for 6 weeks).
Eligibility Criteria
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Inclusion Criteria
* 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
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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José Mª Taboada
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis
Barcelona, , Spain
Countries
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Other Identifiers
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TAX_ES1_209
Identifier Type: -
Identifier Source: org_study_id