Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-Erbitux - Full Text View

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

This study is currently recruiting participants.

Verified by Groupe Oncologie Radiotherapie Tete et Cou, February 2008

Sponsored by:	Groupe Oncologie Radiotherapie Tete et Cou
Information provided by:	Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier:	NCT00609284

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 III

Drug Information available for: Carboplatin Fluorouracil Cetuximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-Erbitux

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
1: Experimental 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
2: Active Comparator 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
Institut Gustave Roussy	Not yet recruiting
Villejuif, France, 94805
Principal Investigator: Jean BOURHIS, MD, PhD
Centre Guillaume Le Conquerant	Recruiting
LE HAVRE, France, 76600
Principal Investigator: Laurent MARTIN, MD
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 hospitalier de Bretagne Sud	Recruiting
Lorient, France, 56322
Principal Investigator: Christian SIRE, MD

Sponsors and Collaborators

Groupe Oncologie Radiotherapie Tete et Cou

Investigators

Study Chair:

Jean BOURHIS, MD, PhD

GORTEC

More Information

Responsible Party:	GORTEC ( BOURHIS Jean, MD, PhD )
Study ID Numbers:	GORTEC 2007-01
Study First Received:	January 25, 2008
Last Updated:	February 18, 2008
ClinicalTrials.gov Identifier:	NCT00609284
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou:

Stage III
Stage IV
locally advanced

Study placed in the following topic categories:

Fluorouracil
Cetuximab
Carboplatin
Carcinoma, squamous cell of head and neck

Additional relevant MeSH terms:

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009