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Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux (GORTEC2007-01)

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:
NCT00609284
First received: January 25, 2008
Last updated: June 23, 2011
Last verified: June 2011
History of Changes
  Purpose

The aim of the trial is to study the efficacy of adding concomitant chemotherapy (carboplatin/5FU) to Erbitux-radiotherapy in patients with locally advanced head and neck cancer.


Condition Intervention Phase
HNSCC
 Drug: cetuximab
Drug: Carboplatin, 5FU concomitant
Radiation: Radiotherapy
 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: Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Loco-regional control [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 406
Study Start Date: February 2008
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Radiotherapy 70Gy, Erbitux, Carboplatin-5FU
 Drug: cetuximab
D-7, D1, D8, D15, D22, D29, D43, D50
Drug: Carboplatin, 5FU concomitant
Carboplatin 70mg/m²/D ; 5FU 600 mg/m²/D, D1-4, D22-25, D43-46
Radiation: Radiotherapy
70 Gy in 7 weeks
Active Comparator: 2
Radiotherapy 70Gy, Erbitux
 Drug: cetuximab
D-7, D1, D8, D15, D22, D29, D43, D50
Radiation: Radiotherapy
70 Gy in 7 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx
  • Stage III - IV (T0-T4, N0-N2b, M0)
  • Not resected
  • Karnofsky PS>=80
  • Informed consent signed

Exclusion Criteria:

  • Contra indication to chemotherapy or cetuximab
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00609284

Contacts
Contact: Jean BOURHIS, MD, PhD 33 1 42 11 49 31 jean.bourhis@igr.fr

Locations
France
Centre hospitalier Annecy Recruiting
Annecy, France, 74000
Principal Investigator: Eva PAPADOPOULOU, MD            
Centre Jean Perrin Recruiting
Clermont Ferrand, France, 63000
Principal Investigator: Michel LAPEYRE, MD            
Centre Guillaume Le Conquerant Recruiting
Le Havre, France, 76600
Principal Investigator: Laurent MARTIN, MD            
Centre hospitalier de Bretagne Sud Recruiting
Lorient, France, 56322
Principal Investigator: Christian SIRE, MD            
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Principal Investigator: Jean BOURHIS, MD, PhD            
Sponsors and Collaborators
Groupe Oncologie Radiotherapie Tete et Cou
Investigators
Study Chair: Jean BOURHIS, MD, PhD GORTEC
  More Information

No publications provided

Responsible Party: BOURHIS Jean, MD, PhD, GORTEC
ClinicalTrials.gov Identifier: NCT00609284     History of Changes
Other Study ID Numbers: GORTEC 2007-01
Study First Received: January 25, 2008
Last Updated: June 23, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou:
Stage III
Stage IV
locally advanced

Additional relevant MeSH terms:
Cetuximab
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013