Chemoradiotherapy HNSCC, Randomized Study, Docetaxel,Cisplatin, 5FU,Erbitux.
NCT01233843 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 370
Last updated 2019-01-18
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.
Conditions
- Squamous Cell Head and Neck Carcinoma
Interventions
- DRUG
-
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
Sponsors & Collaborators
-
Groupe Oncologie Radiotherapie Tete et Cou
lead OTHER
Principal Investigators
-
Lionnel GEOFFROIS, oncologist · Centre Alexis Vautrin NANCY France
-
Etienne BARDET, oncologist · Centre Rene Gauducheau NANTES France
-
Christian SIRE, oncologist · Hopital de Bretagne Sud LORIENT France
-
Laurent MARTIN, oncologist · Centre Guillaume le Conquerant LE HAVRE France
-
Jean-Marc TOURANI, oncologist · CHU POITIERS France
-
Philippe MAINGON, oncologist · Centre Georges Francois Leclerc
-
Ayman ZAWADI, oncologist · CHD de Vendee LA ROCHE SUR YON France
-
François GUICHARD, oncologist · Polyclinique de BORDEAUX NORD France
-
Anne-Françoise DILLIES, oncologist · Centre Jean Perrin CLERMONT FERRAND France
-
Dominique De RAUCOURT, oncologist · Centre François Baclesse CAEN France
-
Emmanuel BABIN, oncologist · Hopital Cote de Nacre CAEN France
-
Claude TUCHAIS, oncologist · Centre Paul Papin ANGERS France
-
XU SHAN Sun, oncologist · Hopital Emile Muller MULHOUSE France
-
Nicolas MEERT, oncologist · Grand Hôpital de Charleroi Belgique
-
Anne-Rose HENRY, oncologist · CHU André Vésale MONTIGNY Belgique
-
Cedrik LAFOND, oncologist · Centre Jean Bernard LE MANS France
-
Thierry PIGNON, oncologist · Centre Saint Louis TOULON France
-
Ali HASBINI, oncologist · Clinique Armoricaine SAINT BRIEUC France
-
Jean BOURHIS, oncologist · Institut Gustave Roussy VILLEJUIF France
-
Marie SALIOU, oncologist · Centre Etienne Dolet SAINT NAZAIRE France
-
Alexandre COUTTE, oncologist · CHU sud AMIENS France
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-05-18
- Primary Completion
- 2018-11-06
- Completion
- 2018-11-06
Countries
- France
Study Locations
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