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

NCT00916097 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2009-06-24

No results posted yet for this study

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

DRUG

DOCETAXEL(XRP6976)

docetaxel 75mg/m2 by intravenous infusion over 60 minutes on Day 1 of a 3-week cycle

Sponsors & Collaborators

Principal Investigators

  • Christian Fassotte · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Primary Completion
2005-11-30
Completion
2005-11-30

Countries

  • Algeria
  • Morocco
  • Tunisia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00916097 on ClinicalTrials.gov