NCT00916097

NPC Study : TAX + CIS Neoadjuvant in Patients With Loco Regionally Advanced Undifferentiated Carcinoma of Nasopharyngeal Type (UCNT)

A Multicenter Phase II Trial of Docetaxel Combined With Cisplatin (CDDP) as a Neo-Adjuvant Chemotherapy in Patients With Loco Regionally Advanced Undifferentiated Carcinoma of Nasopharyngeal Type (UCNT)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To estimate the overall response rate after neo-adjuvant chemotherapy of Docetaxel 75 mg/m2 in combination with Cisplatin 75 mg/m2 given for 3 cycles, and followed by conventional radiotherapy in UCNT. Secondary Objectives: To evaluate: * The radiological response after chemotherapy and radiotherapy * The pathological response after chemotherapy by cavum biopsy To estimate: * The duration of overall response * The time to progression (T.T.P) To analyze: * The overall survival * The safety profile

Conditions

• Head and Neck Neoplasms

Interventions

Type	Name	Description
DRUG	DOCETAXEL(XRP6976)	docetaxel 75mg/m2 by intravenous infusion over 60 minutes on Day 1 of a 3-week cycle

Timeline

• Start date: 2002-07-01
• Primary completion: 2005-11-01
• Completion: 2005-11-01
• First posted: 2009-06-09
• Last updated: 2009-06-24

Locations

3 sites across 3 countries: Algeria, Morocco, Tunisia