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Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents

NCT00565448 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2015-07-30

Study results available
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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.

Conditions

  • Nasopharyngeal Neoplasms
  • Carcinoma

Interventions

DRUG

docetaxel

Pharmaceutical form:solution for infusion Route of administration:intravenous

DRUG

cisplatin

Pharmaceutical form:solution for infusion Route of administration:intravenous

DRUG

5-fluorouracil

Pharmaceutical form:solution for infusion Route of administration:intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-03-31
Completion
2012-01-31

Countries

  • Algeria
  • Brazil
  • China
  • France
  • India
  • Indonesia
  • Italy
  • Mexico
  • Morocco
  • Philippines
  • South Korea
  • Thailand
  • Tunisia
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
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 NCT00565448 on ClinicalTrials.gov