We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2015 by Groupe Oncologie Radiotherapie Tete et Cou.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00609284
First Posted: February 7, 2008
Last Update Posted: March 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Groupe Oncologie Radiotherapie Tete et Cou
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Loco-regional control [ Time Frame: 3 years ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier: NCT00609284     History of Changes
Other Study ID Numbers: GORTEC 2007-01
First Submitted: January 25, 2008
First Posted: February 7, 2008
Last Update Posted: March 24, 2015
Last Verified: March 2015

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

Additional relevant MeSH terms:
Carboplatin
Cetuximab
Antineoplastic Agents