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Induction CT by Cisplatin, 5FU With or Without Docetaxel in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma

NCT00169182 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2019-02-15

No results posted yet for this study

Summary

The purpose of the study is to compare two regimen of chemotherapy used as first treatment for patients with larynx or hypopharynx tumors that would be treated with total laryngectomy. The standard treatment is a combination of 2 drugs (Cisplatin and 5FU). The aim of the study is to evaluate the potential benefit of the addition of a third drug (Docetaxel) in the chemotherapy regimen. Patients will receive 3 cycles of chemotherapy. Responders to the induction treatment are treated with radiation with a purpose of larynx preservation. Non responders patients will be treated with total laryngectomy.

Conditions

  • Larynx Cancer
  • Hypopharynx Cancer

Interventions

DRUG

DOCETAXEL

75 mg/m 2 on day 1

DRUG

Cisplatin

75 mg/m 2 on day 1

DRUG

5-Fluoro-3-Pyridinecarboxylic Acid

750 mg/m 2 by 24-hour continuous infusion for 5 days

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Groupe Oncologie Radiotherapie Tete et Cou

    lead OTHER

Principal Investigators

  • Gilles Calais, MD · CHU Bretonneau

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2001-12-15
Primary Completion
2009-04-30
Completion
2009-05-31

Countries

  • France

Study Locations

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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 NCT00169182 on ClinicalTrials.gov