Chemoradiotherapy HNSCC, Randomized Study, Docetaxel,Cisplatin, 5FU,Erbitux. (2007/02)

January 17, 2019 updated by: Groupe Oncologie Radiotherapie Tete et Cou

A Phase III Randomized Multicenter Study,Comparing an Induction Chemotherapy Followed by Irradiation and Concurrent Erbitux Versus Chemoradiotherapy for Patients With Locoregional Advanced Head and Neck Cancers

The purpose of this study is to demonstrate that induction chemotherapy followed by radiation therapy plus Cetuximab will give better results than the validated treatment (chemoradiotherapy), for treatment of locoregional advanced head and neck cancers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Concurrent chemoradiotherapy (radiotherapy+ carboplatin + 5FU) is a validated treatment for patients with locoregional advanced head and neck cancers.

This study evaluates the outcome of induction chemotherapy (docetaxel, cisplatin, 5 FU) followed by radiation therapy + Erbitux for patients with head and neck carcinoma with almost one measurable lesion by RMI or CT scan.

We hope we can improve the progression free survival of 14% at two years .

Study Type

Interventional

Enrollment (Actual)

370

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
      • Tours, France, 37044
        • GIRARD CALAIS Marie-Helene

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:

  • head and neck locally advanced,non metastatic carcinoma
  • not suitable for surgery

Exclusion Criteria:

  • non squamous cell head and neck cancer
  • previous malignancy
  • previous treatment

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
Other: Drug and radiation
Radiotherapy : 70 grays , fractionization : 2Gy/day, 5 days / week, for 7 weeks . Concurrent administration of Carboplatin: 70 mg/m2/day (day 1 until day 4)and 5FU 600 mg/m2/day (day 1 until day 4). Weeks 1; 4; 7.
Drug: carboplatin
70 mg per m2 and per day for four days. day 1; day 22; day 43
Drug: 5 fluorouracil
600mg per m2 per day for four days. 3 cycles day 1; day 22; day 43
Radiation: radiation therapy
total dose: 70 grays. The patient receives 2 grays per day; five days a week during 7 weeks
Experimental: drug and radiation

Induction chemotherapy by Docetaxel 100mg/m2, day 1; cisplatin 100mg/m2, day 1; 5-Fluorouracil 1000mg/m2 (from day 1 to day 5), for a total of three cycles .Those cycles are administrated at day 1; day 22, day43.

This induction chemotherapy is followed ( for responders or stable disease patients)by radiotherapy (70 grays for 7 weeks) and concurrent Erbitux( weekly administration).
Drug: carboplatin
70 mg per m2 and per day for four days. day 1; day 22; day 43
Drug: 5 fluorouracil
600mg per m2 per day for four days. 3 cycles day 1; day 22; day 43
Radiation: radiation therapy
total dose: 70 grays. The patient receives 2 grays per day; five days a week during 7 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate of the treatment
Time Frame: by CT scan or MRI and endoscopy 2 years after the end of treatment
measure of the tumor
by CT scan or MRI and endoscopy 2 years after the end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The second focus of this study is to compare Overall survival between the two arms . It is defined as the time from the date of randomization to the date of death from any cause.
Time Frame: Date of death
Aftercare every six months
Date of death

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 Director: Lionnel GEOFFROIS, oncologist, Centre Alexis Vautrin NANCY France
  • Principal Investigator: Etienne BARDET, oncologist, Centre Rene Gauducheau NANTES France
  • Principal Investigator: Christian SIRE, oncologist, Hopital de Bretagne Sud LORIENT France
  • Principal Investigator: Laurent MARTIN, oncologist, Centre Guillaume le Conquerant LE HAVRE France
  • Principal Investigator: Jean-Marc TOURANI, oncologist, CHU POITIERS France
  • Principal Investigator: Philippe MAINGON, oncologist, Centre Georges Francois Leclerc
  • Principal Investigator: Ayman ZAWADI, oncologist, CHD de Vendee LA ROCHE SUR YON France
  • Principal Investigator: François GUICHARD, oncologist, Polyclinique de BORDEAUX NORD France
  • Principal Investigator: Anne-Françoise DILLIES, oncologist, Centre Jean Perrin CLERMONT FERRAND France
  • Principal Investigator: Dominique De RAUCOURT, oncologist, Centre François Baclesse CAEN France
  • Principal Investigator: Emmanuel BABIN, oncologist, Hopital Cote de Nacre CAEN France
  • Principal Investigator: Claude TUCHAIS, oncologist, Centre Paul Papin ANGERS France
  • Principal Investigator: XU SHAN Sun, oncologist, Hopital Emile Muller MULHOUSE France
  • Principal Investigator: Nicolas MEERT, oncologist, Grand Hôpital de Charleroi Belgique
  • Principal Investigator: Anne-Rose HENRY, oncologist, CHU André Vésale MONTIGNY Belgique
  • Principal Investigator: Cedrik LAFOND, oncologist, Centre Jean Bernard LE MANS France
  • Principal Investigator: Thierry PIGNON, oncologist, Centre Saint Louis TOULON France
  • Principal Investigator: Ali HASBINI, oncologist, Clinique Armoricaine SAINT BRIEUC France
  • Principal Investigator: Jean BOURHIS, oncologist, Institut Gustave Roussy VILLEJUIF France
  • Principal Investigator: Marie SALIOU, oncologist, Centre Etienne Dolet SAINT NAZAIRE France
  • Principal Investigator: Alexandre COUTTE, oncologist, CHU sud AMIENS France

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)

May 18, 2009

Primary Completion (Actual)

November 6, 2018

Study Completion (Actual)

November 6, 2018

Study Registration Dates

First Submitted

October 25, 2010

First Submitted That Met QC Criteria

November 2, 2010

First Posted (Estimate)

November 3, 2010

Study Record Updates

Last Update Posted (Actual)

January 18, 2019

Last Update Submitted That Met QC Criteria

January 17, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GORTEC 2007-02

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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