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

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: Squamous Cell Head and Neck Carcinoma
• Intervention / Treatment: Drug: carboplatin; Drug: 5 fluorouracil; Radiation: radiation therapy

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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	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.	Aftercare every six months	Date of death

Collaborators and Investigators

• 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

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: induction chemotherapy; followed by irradiation and concurrent Erbitux, or radiochemotherapy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Carboplatin; Fluorouracil
• Other Study ID Numbers: GORTEC 2007-02