Safety Study of Docetaxel/Cisplatin Induction Therapy Followed by Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Followed by Consolidation Docetaxel/Cisplatin in NSCLC Patients
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|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 ]
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): NCT00271323
|Study Director:||M COUDERC, Dr||Sanofi|