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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier:
NCT00609284
First received: January 25, 2008
Last updated: August 6, 2014
Last verified: August 2014
  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:


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 Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (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
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: NCT00609284

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

No publications provided

Responsible Party: Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier: NCT00609284     History of Changes
Other Study ID Numbers: GORTEC 2007-01
Study First Received: January 25, 2008
Last Updated: August 6, 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:
Stage III
Stage IV
locally advanced

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

ClinicalTrials.gov processed this record on October 16, 2014