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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier:
NCT01233843
First received: October 25, 2010
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Squamous Cell Head and Neck Carcinoma
Drug: carboplatin
Drug: 5 fluorouracil
Radiation: radiation therapy
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Groupe Oncologie Radiotherapie Tete et Cou:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 370
Study Start Date: May 2009
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233843

Locations
France
GIRARD CALAIS Marie-Helene
Tours, France, 37044
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier: NCT01233843     History of Changes
Other Study ID Numbers: GORTEC 2007-02
Study First Received: October 25, 2010
Last Updated: January 2, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou:
induction chemotherapy
followed by irradiation and concurrent Erbitux, or radiochemotherapy

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Carboplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2014