Safety Study of Docetaxel/Cisplatin Induction Therapy Followed by Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Followed by Consolidation Docetaxel/Cisplatin in NSCLC Patients
|ClinicalTrials.gov Identifier: NCT00271323|
Recruitment Status : Terminated
First Posted : December 30, 2005
Last Update Posted : December 23, 2009
- Primary : To determine the safety profile of each treatment group.
- Secondary : To determine efficacy in term of overall response, disease free survival and survival at 1 and 2 years.
|Condition or disease||Intervention/treatment||Phase|
|Non-Small-Cell Lung Carcinoma||Drug: docetaxel and cisplatin Radiation: radiotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Two Arm Phase II Study Assessing Docetaxel/Cisplatin Induction Therapy Followed by Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Followed by Consolidation Docetaxel/Cisplatin in Patients With Locally Advanced Unresectable NSCLC (Stage IIIA-multiple cN2 or IIIB)|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||February 2007|
|Actual Study Completion Date :||February 2007|
Induction chemotherapy followed by concurrent chemoradiotherapy
Drug: docetaxel and cisplatin
Docetaxel (75 mg/m2, IV, Day 1) and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles, followed by concurrent chemo-radiotherapy with docetaxel (20 mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy.
Active Comparator: 2
Concurrent chemo-radiotherapy followed by consolidation chemotherapy
Docetaxel (20 mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy followed by docetaxel (75 mg/m2, IV, Day 1) and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles.
- overall response rate [ Time Frame: in population of patients eligible and evaluable for response ]
- time to progression [ Time Frame: from the date of start treatment until progression ]
- duration of response [ Time Frame: only on responders ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00271323
|Study Director:||M COUDERC, Dr||Sanofi|