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

Phase 2

Completed

• Conditions: Head and Neck Neoplasms
• Interventions: Drug: DOCETAXEL(XRP6976)

• Registration Number: NCT00916097
• Lead Sponsor: Sanofi

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Status Verified: 2009-06
• Study First Submitted: 2009-06-05
• Study First Submitted QC: 2009-06-05
• Study First Posted: 2009-06-09
• Last Update Submitted: 2009-06-23
• Last Update Posted: 2009-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	DOCETAXEL(XRP6976)	docetaxel 75mg/m2 in combination with cisplatin 75mg/m2 given every 3 weeks for 3 cycles

Primary Outcome Measures

Name	Time	Method
Evaluation of tumor response in patients with measurable disease according to RECIST criteria	on day 21 of each treatment cycle for neoadjuvant chemotherapy, on day 64 and day 71 (3 to 4 weeks after the third chemotherapy)

Secondary Outcome Measures

Name	Time	Method
Overall response duration	from baseline to the end of the study
Estimation of the time to progression	from baseline to the end of the study
Overall survival	from baseline to the end of the study
Evaluation of the radiological response after chemotherapy and radiotherapy	from baseline to the end of the study
Evaluation of the pathological response after chemotherapy	between day 64 and day 71 of the treatment

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇹🇳 Megrine, Tunisia