Clinical trial NCT01233843: Chemoradiotherapy HNSCC, Randomized Study, Docetaxel,Cisplatin, 5FU,Erbitux.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Squamous Cell Head and Neck Carcinoma
Keywords: induction chemotherapy
followed by irradiation and concurrent Erbitux, or radiochemotherapy
Lead sponsor: Groupe Oncologie Radiotherapie Tete et Cou
Sponsor class: OTHER
First posted: 2010-11-03
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 .

Eligibility criteria: 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

Primary outcomes:
measure: Complete response rate of the treatment
timeFrame: by CT scan or MRI and endoscopy 2 years after the end of treatment
Secondary outcomes:
measure: 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.
timeFrame: Date of death
Other outcomes:
Locations:
city: Tours
country: France
facility: GIRARD CALAIS Marie-Helene
Study officials:
affiliation: Centre Alexis Vautrin NANCY France
name: Lionnel GEOFFROIS, oncologist
role: STUDY_DIRECTOR
affiliation: Centre Rene Gauducheau NANTES France
name: Etienne BARDET, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital de Bretagne Sud LORIENT France
name: Christian SIRE, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Guillaume le Conquerant LE HAVRE France
name: Laurent MARTIN, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU POITIERS France
name: Jean-Marc TOURANI, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Georges Francois Leclerc
name: Philippe MAINGON, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: CHD de Vendee LA ROCHE SUR YON France
name: Ayman ZAWADI, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Polyclinique de BORDEAUX NORD France
name: François GUICHARD, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Jean Perrin CLERMONT FERRAND France
name: Anne-Françoise DILLIES, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre François Baclesse CAEN France
name: Dominique De RAUCOURT, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Cote de Nacre CAEN France
name: Emmanuel BABIN, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Paul Papin ANGERS France
name: Claude TUCHAIS, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Emile Muller MULHOUSE France
name: XU SHAN Sun, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Grand Hôpital de Charleroi Belgique
name: Nicolas MEERT, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU André Vésale MONTIGNY Belgique
name: Anne-Rose HENRY, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Jean Bernard LE MANS France
name: Cedrik LAFOND, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Saint Louis TOULON France
name: Thierry PIGNON, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Armoricaine SAINT BRIEUC France
name: Ali HASBINI, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Gustave Roussy VILLEJUIF France
name: Jean BOURHIS, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Etienne Dolet SAINT NAZAIRE France
name: Marie SALIOU, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU sud AMIENS France
name: Alexandre COUTTE, oncologist
role: PRINCIPAL_INVESTIGATOR
References: