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

This study is currently recruiting participants.

Verified June 2011 by Groupe Oncologie Radiotherapie Tete et Cou

Sponsor:

Information provided by:

Groupe Oncologie Radiotherapie Tete et Cou

ClinicalTrials.gov Identifier:

NCT01233843

First received: October 25, 2010

Last updated: June 23, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

October 25, 2010

Last Updated Date

June 23, 2011

Start Date ^ICMJE

May 2009

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Complete response rate of the treatment [ Time Frame: by CT scan or MRI and endoscopy 2 years after the end of treatment ] [ Designated as safety issue: No ]

measure of the tumor

Original Primary Outcome Measures ^ICMJE

Measurement of tumor size (RECIST criteria)by MRI ou CTscan. [ Time Frame: 2010:end of treatment period ; up to 2018 end of périod of follow-up; (average time) ] [ Designated as safety issue: No ]

This measurement will be done 6 months, one year and two years after the end of treatment.

Change History

Complete list of historical versions of study NCT01233843 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Aftercare every six months

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Chemoradiotherapy HNSCC, Randomized Study, Docetaxel,Cisplatin, 5FU,Erbitux.

Official Title ^ICMJE

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

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 .

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Squamous Cell Head and Neck Carcinoma

Intervention ^ICMJE

Drug: carboplatin
70 mg per m2 and per day for four days. day 1; day 22; day 43

Other Name: carboplatin
Drug: 5 fluorouracil
600mg per m2 per day for four days. 3 cycles day 1; day 22; day 43

Other Name: 5 Fluorouracil
Radiation: radiation therapy
total dose: 70 grays. The patient receives 2 grays per day; five days a week during 7 weeks

Study Arm (s)

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.
Interventions:
- Drug: carboplatin
- Drug: 5 fluorouracil
- Radiation: radiation therapy
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).
Interventions:
- Drug: carboplatin
- Drug: 5 fluorouracil
- Radiation: radiation therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

360

Estimated Completion Date

May 2015

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: GIRARD CALAIS Marie-Helene, CRA	33 2 47 47 91 21	rc.corad@chu-tours.fr
Contact: BRACONNIER Delphine, CRA	33 2 47 47 91 21	rc.corad@chu-tours.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01233843

Other Study ID Numbers ^ICMJE

GORTEC 2007-02

Has Data Monitoring Committee

Yes

Responsible Party

Docteur Lionnel GEOFFROIS, coordonnateur

Study Sponsor ^ICMJE

Groupe Oncologie Radiotherapie Tete et Cou

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Groupe Oncologie Radiotherapie Tete et Cou

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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