NCT00609284

Brief Summary

The aim of the trial is to study the efficacy of adding concomitant chemotherapy (carboplatin/5FU) to Erbitux-radiotherapy in patients with locally advanced head and neck cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
406

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_3

Geographic Reach
1 country

5 active sites

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

First Submitted

Initial submission to the registry

January 25, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 7, 2008

Completed
8 days until next milestone

Study Start

First participant enrolled

February 15, 2008

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2019

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

10.1 years

First QC Date

January 25, 2008

Last Update Submit

April 14, 2020

Conditions

HNSCC

Keywords

Stage IIIStage IVlocally advanced

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    3 years

Secondary Outcomes (1)

  • Loco-regional control

    3 years

Study Arms (2)

1

EXPERIMENTAL

Radiotherapy 70Gy, Erbitux, Carboplatin-5FU

Drug: cetuximabDrug: Carboplatin, 5FU concomitantRadiation: Radiotherapy

2

ACTIVE COMPARATOR

Radiotherapy 70Gy, Erbitux

Drug: cetuximabRadiation: Radiotherapy

Interventions

cetuximabDRUG

D-7, D1, D8, D15, D22, D29, D43, D50

12
Carboplatin, 5FU concomitantDRUG

Carboplatin 70mg/m²/D ; 5FU 600 mg/m²/D, D1-4, D22-25, D43-46

1
RadiotherapyRADIATION

70 Gy in 7 weeks

12

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx
  • Stage III - IV (T0-T4, N0-N2b, M0)
  • Not resected
  • Karnofsky PS\>=80
  • Informed consent signed

You may not qualify if:

  • Contra indication to chemotherapy or cetuximab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Centre hospitalier Annecy

Annecy, 74000, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63000, France

Location

Centre Guillaume Le Conquerant

Le Havre, 76600, France

Location

Centre hospitalier de Bretagne Sud

Lorient, 56322, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

CetuximabCarboplatinRadiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCoordination ComplexesOrganic ChemicalsTherapeutics

Study Officials

  • Jean BOURHIS, MD, PhD

    GORTEC

    STUDY CHAIR

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

January 25, 2008

First Posted

February 7, 2008

Study Start

February 15, 2008

Primary Completion

March 26, 2018

Study Completion

March 26, 2019

Last Updated

April 15, 2020

Record last verified: 2020-04

Locations

FR(5)