NCT00162708

Brief Summary

Altered fractionated radiotherapy and concomitant radio-chemotherapy have been shown to be two possibilities for improving efficacy of radiotherapy in locally advanced head and neck carcinomas. In this multicentric study, we tested the hypothesis that accelerated radiotherapy could be delivered concomitantly with conventional high doses of CDDP-5FU, aiming to improve both local control and on distant metastases as compared to very accelerated radiotherapy.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1996

Completed
9.2 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
Last Updated

September 13, 2005

Status Verified

September 1, 2005

First QC Date

September 9, 2005

Last Update Submit

September 9, 2005

Conditions

Oropharynx CancerOral CancerHypopharynx CancerLarynx Cancer

Keywords

Head and neck squamous cell carcinomaRadiotherapyChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Event free survival (event = progressive disease or relapse or or death from any cause)

Secondary Outcomes (2)

  • Survival

  • Toxicity

Interventions

Radiotherapy 62-64 Gy in 5 W (31-32 f. of 2 Gy BID)PROCEDURE
Radiotherapy 62-64 Gy in 22-23 D (31-32 f of 2 Gy BID)PROCEDURE
CDDP, 5 FuDRUG

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • palpable N2b-c or N3 (UICC 1997) squamous cell carcinoma of the head and neck (oropharynx, oral cavity, hypopharynx or larynx)
  • primary tumor and / or nodal extension strictly inoperable due to the extension of the disease
  • performance status of 0 to 2 (WHO scoring system)
  • renal/liver/cardiac functions and blood counts compatible with the use of CDDP and 5-FU
  • signed inform consent

You may not qualify if:

  • distant metastasis
  • previous history of cancer
  • previous radiotherapy or chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre Jean Perrin

Clermont-Ferrand, France

Location

Centre Alexis Vautrin

Nancy, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Oropharyngeal NeoplasmsMouth NeoplasmsHypopharyngeal NeoplasmsLaryngeal NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

Fluorouracil

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesMouth DiseasesLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jean Bourhis

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

  • Michel Lapeyre

    Centre Alexis Vautrin

    PRINCIPAL INVESTIGATOR

  • Jacques Tortochaux

    Centre Jean Perrin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 13, 2005

Study Start

July 1, 1996

Last Updated

September 13, 2005

Record last verified: 2005-09

Locations

FR(3)