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

February 13, 2019 updated by: Groupe Oncologie Radiotherapie Tete et Cou

Randomized Study Comparing Induction Chemotherapy With Docetaxel, Cisplatin, 5FU Versus Cisplatin, 5 FU in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of the study is to compare two regimen of induction chemotherapy for patients with T3 and T4 larynx or hypopharynx carcinoma that would be treated with total laryngectomy. The aim of the study is to compare the standard regimen (Cisplatin + 5FU) versus the TPF regimen (Taxotere + Cisplatin + 5FU). Responders to the induction treatment are treated with radiation with a purpose of larynx preservation. Non responders patients will be treated with total laryngectomy followed by postoperative radiation.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Tours, France, 37044
        • CHU Bretonneau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • T3 and T4 larynx and hypopharynx tumor that would be treated with total laryngectomy
  • Biopsy proven carcinoma
  • Adequate biology
  • Performance status 0 or 1

Exclusion Criteria:

  • Larynx or hypopharynx tumors that could be treated with partial laryngectomy
  • Distant metastasis
  • Prior surgery, chemotherapy or radiation
  • Intercurrent disease that is a contra indication to chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TPF
Docetaxel, Cisplatine, 5-FU
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
Active Comparator: PF
Cisplatine, 5-FU
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
3-years larynx preservation rate

Secondary Outcome Measures

Outcome Measure
5-years survival rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Oncologie Radiotherapie Tete et Cou

Collaborators

Sanofi

Investigators

  • Principal Investigator: Gilles Calais, MD, CHU Bretonneau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2001

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 13, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GORTEC 2000-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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