NCT00169182

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2001

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2001

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

7.3 years

First QC Date

September 9, 2005

Last Update Submit

February 13, 2019

Conditions

Larynx CancerHypopharynx Cancer

Keywords

Larynx cancerHypopharynx cancerChemotherapyRandomized trialLarynx preservation

Outcome Measures

Primary Outcomes (1)

  • 3-years larynx preservation rate

Secondary Outcomes (1)

  • 5-years survival rate

Study Arms (2)

TPF

EXPERIMENTAL

Docetaxel, Cisplatine, 5-FU

Drug: DOCETAXELDrug: CisplatinDrug: 5-Fluoro-3-Pyridinecarboxylic Acid

PF

ACTIVE COMPARATOR

Cisplatine, 5-FU

Drug: CisplatinDrug: 5-Fluoro-3-Pyridinecarboxylic Acid

Interventions

DOCETAXELDRUG

75 mg/m 2 on day 1

TPF
CisplatinDRUG

75 mg/m 2 on day 1

PFTPF
5-Fluoro-3-Pyridinecarboxylic AcidDRUG

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

PFTPF

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Bretonneau

Tours, 37044, France

Location

MeSH Terms

Conditions

Laryngeal NeoplasmsHypopharyngeal Neoplasms

Interventions

DocetaxelCisplatin5-fluoro-3-pyridinecarboxylic acid

Condition Hierarchy (Ancestors)

Otorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsOtorhinolaryngologic DiseasesPharyngeal NeoplasmsPharyngeal DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Gilles Calais, MD

    CHU Bretonneau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

December 15, 2001

Primary Completion

April 1, 2009

Study Completion

May 1, 2009

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

FR(1)