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

Primary Purpose

Larynx Cancer, Hypopharynx Cancer

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

DOCETAXEL

Cisplatin

5-Fluoro-3-Pyridinecarboxylic Acid

About this trial

This is an interventional treatment trial for Larynx Cancer focused on measuring Larynx cancer, Hypopharynx cancer, Chemotherapy, Randomized trial, Larynx preservation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU Bretonneau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TPF

Arm Description

Docetaxel, Cisplatine, 5-FU

Cisplatine, 5-FU

Outcomes

Primary Outcome Measures

3-years larynx preservation rate

Secondary Outcome Measures

5-years survival rate

Full Information

NCT ID

NCT00169182

First Posted

September 9, 2005

Last Updated

February 13, 2019

Sponsor

Groupe Oncologie Radiotherapie Tete et Cou

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00169182

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

December 15, 2001 (Actual)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Groupe Oncologie Radiotherapie Tete et Cou

Collaborators

Sanofi

4. Oversight

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Larynx Cancer, Hypopharynx Cancer

Keywords

Larynx cancer, Hypopharynx cancer, Chemotherapy, Randomized trial, Larynx preservation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

220 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TPF

Arm Type

Experimental

Arm Description

Docetaxel, Cisplatine, 5-FU

Arm Title

Arm Type

Active Comparator

Arm Description

Cisplatine, 5-FU

Intervention Type

Drug

Intervention Name(s)

DOCETAXEL

Intervention Description

75 mg/m 2 on day 1

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

75 mg/m 2 on day 1

Intervention Type

Drug

Intervention Name(s)

5-Fluoro-3-Pyridinecarboxylic Acid

Intervention Description

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

Primary Outcome Measure Information:

Title

3-years larynx preservation rate

Secondary Outcome Measure Information:

Title

5-years survival rate

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilles Calais, MD

Organizational Affiliation

CHU Bretonneau

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Bretonneau

City

Tours

ZIP/Postal Code

37044

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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