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Induction Chemotherapy and Chemoradiotherapy in Nasopharyngeal Cancers

NCT00828386 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2019-01-18

No results posted yet for this study

Summary

This is a randomized, multicenter, phase III trial comparing induction chemotherapy with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) followed by concurrent chemoradiotherapy to concurrent chemoradiotherapy alone, in nasopharyngeal cancers staged as T2b, T3, T4 and/or with lymph node involvement (≥ N1. The main end point is the event free survival.

Conditions

  • Nasopharyngeal Cancers

Interventions

PROCEDURE

Induction chemotherapy + concurrent radiochemotherapy vs. concurrent radiochemotherapy

Induction chemotherapy (Docetaxel, Cisplatin and 5-Fluorouracil) + concurrent radiochemotherapy

Sponsors & Collaborators

  • Groupe Oncologie Radiotherapie Tete et Cou

    lead OTHER

Principal Investigators

  • Jamel Daoud, Pr · Hôpital Habib Bourguiba-3029 Sfax-Tunisie

  • Mounir FRIKHA, Pr · Hôpital Habib Bourguiba-3029 Sfax-Tunisie

  • Jean BOURHIS, Pr · Institut Gustave Roussy, 39 rue Camille Desmoulin, Villejuif, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2017-04-19
Completion
2017-04-19

Countries

  • France
  • Morocco
  • Romania
  • Tunisia

Study Locations

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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 NCT00828386 on ClinicalTrials.gov