Lung Neoplasms
Conditions
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.
Interventions
DRUGDocetaxel + 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.
OTHERDocetaxel + 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).
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate in each arm measured according to RECIST criteria | Throughout the whole study |
Secondary
| Measure | 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 |
Countries
Spain
Outcome results
None listed