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

NCT01233843 | Completed Phase 3 DMC

• 1 other identifier: GORTEC 2007-02
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

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.

Conditions

Squamous Cell Head and Neck Carcinoma

Keywords

induction chemotherapy; followed by irradiation and concurrent Erbitux, or radiochemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

  Date of death

Study Arms (2)

Drug and radiation

OTHER

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; Drug: 5 fluorouracil; Radiation: radiation therapy

drug and radiation

EXPERIMENTAL

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; Drug: 5 fluorouracil; Radiation: radiation therapy

Interventions

carboplatin DRUG

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

Drug and radiation; drug and radiation

5 fluorouracil DRUG

600mg per m2 per day for four days. 3 cycles day 1; day 22; day 43

Drug and radiation; drug and radiation

radiation therapy RADIATION

total dose: 70 grays. The patient receives 2 grays per day; five days a week during 7 weeks

Drug and radiation; drug and radiation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Groupe Oncologie Radiotherapie Tete et Cou: lead

Study Sites (1)

GIRARD CALAIS Marie-Helene

Tours, 37044, France

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Carboplatin; Fluorouracil; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Lionnel GEOFFROIS, oncologist

  Centre Alexis Vautrin NANCY France

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2010
• First Posted: November 3, 2010
• Study Start: May 18, 2009
• Primary Completion: November 6, 2018
• Study Completion: November 6, 2018
• Last Updated: January 18, 2019

Record last verified: 2019-01

Locations

FR (1)