Docetaxel in Non Small Cell Lung Cancer (NSCLC)
|ClinicalTrials.gov Identifier: NCT00258739|
Recruitment Status : Completed
First Posted : November 28, 2005
Last Update Posted : December 7, 2009
- To classify the 2 study groups, according to the tumoral response.
- To evaluate the percentage of focused control per year.
- To calculate the time until progression.
- To evaluate the safety profile.
|Condition or disease||Intervention/treatment||Phase|
|Lung Neoplasms||Drug: Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine Other: Docetaxel + gemcitabine + carboplatin + radiotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||October 2001|
|Primary Completion Date :||September 2007|
Concomitant radiotherapy and carboplatin-docetaxel followed by docetaxel-gemcitabine
Drug: 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 followed by concomitant radiotherapy with carboplatin-docetaxel
Other: 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).
- Response rate in each arm measured according to RECIST criteria [ Time Frame: Throughout the whole study ]
- Percentage of local-regional control within a year [ Time Frame: Throughout the first year ]
- Time to progression defined as the period of time elapsed between the randomization date and the progression or death date [ Time Frame: Throughout the whole study ]
- Toxicity measured by CALGB criteria and RTOG/EORTC criteria [ Time Frame: Throughout the whole study ]
- Global surveillance measured as the period of time elapsed between randomization and death date. [ Time Frame: Throughout the whole study duration ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00258739
|Study Director:||José Mª Taboada||Sanofi|