Docetaxel in Non Small Cell Lung Cancer (NSCLC)

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II, Randomized Study With Docetaxel-gemcitabine Followed by Radiotherapy vs Concomitant Treatment (Radiotherapy and Carboplatine-docetaxel) Followed by Docetaxel-gemcitabine Versus Docetaxel-gemcitabine Followed by Concomitant Treatment (Radiotherapy and Carboplatine-docetaxel) in Stage III NSCLC

Conditions
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Lung Neoplasms

Intervention / Treatment
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* Drug: Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine
* Other: Docetaxel + gemcitabine + carboplatin + radiotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Concomitant radiotherapy and carboplatin-docetaxel followed by docetaxel-gemcitabine | Drug: Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine<br>* 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.<br>|
| Experimental: 2<br>docetaxel-gemcitabine followed by concomitant radiotherapy with carboplatin-docetaxel | Other: Docetaxel + gemcitabine + carboplatin + radiotherapy<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate in each arm measured according to RECIST criteria |  | Throughout the whole study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |