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Clinical Trial Summary

The primary objective is to estimate the Complete Response rate of docetaxel to the combination of cisplatin-5-fluorouracil (TCF) compared to cisplatin-5-fluorouracil (CF) in the Induction treatment of Nasopharyngeal Carcinoma (NPC).

The secondary objectives are to determine:

- the safety of TCF in comparison to CF after induction treatment of NPC,

- the pharmacokinetics of docetaxel when added to CF,

- the Overall Response rate of TCF and CF on completion of induction and consolidation (chemo-radiotherapy) treatment of NPC, and to compare overall survival between TCF and CF.


Clinical Trial Description

Planned treatment duration:

- induction period: 9 weeks of induction treatment

- consolidation period: 9 weeks of chemoradiation treatment.

The consolidation treatment was the same for all participants: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00565448
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 2
Start date November 2007
Completion date January 2012

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