Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux (2007-01)

April 14, 2020 updated by: Groupe Oncologie Radiotherapie Tete et Cou
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

406

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
      • Annecy, France, 74000
        • Centre hospitalier Annecy
      • Clermont Ferrand, France, 63000
        • Centre Jean Perrin
      • Le Havre, France, 76600
        • Centre Guillaume Le Conquerant
      • Lorient, France, 56322
        • Centre Hospitalier de Bretagne Sud
      • Villejuif, France, 94805
        • Institut Gustave Roussy

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Contra indication to chemotherapy or cetuximab

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: 1
Radiotherapy 70Gy, Erbitux, Carboplatin-5FU
Drug: cetuximab
D-7, D1, D8, D15, D22, D29, D43, D50
Drug: Carboplatin, 5FU concomitant
Carboplatin 70mg/m²/D ; 5FU 600 mg/m²/D, D1-4, D22-25, D43-46
Radiation: Radiotherapy
70 Gy in 7 weeks
Active Comparator: 2
Radiotherapy 70Gy, Erbitux
Drug: cetuximab
D-7, D1, D8, D15, D22, D29, D43, D50
Radiation: Radiotherapy
70 Gy in 7 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Loco-regional control
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

Groupe Oncologie Radiotherapie Tete et Cou

Investigators

  • Study Chair: Jean BOURHIS, MD, PhD, GORTEC

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)

February 15, 2008

Primary Completion (Actual)

March 26, 2018

Study Completion (Actual)

March 26, 2019

Study Registration Dates

First Submitted

January 25, 2008

First Submitted That Met QC Criteria

February 6, 2008

First Posted (Estimate)

February 7, 2008

Study Record Updates

Last Update Posted (Actual)

April 15, 2020

Last Update Submitted That Met QC Criteria

April 14, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GORTEC 2007-01

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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