Docetaxel in Non Small Cell Lung Cancer (NSCLC)
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|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|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00258739
|Study Director:||José Mª Taboada||Sanofi|