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Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux (2007-01)

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ClinicalTrials.gov Identifier: NCT00609284
Recruitment Status : Active, not recruiting
First Posted : February 7, 2008
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
Groupe Oncologie Radiotherapie Tete et Cou

Brief Summary:
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 or disease Intervention/treatment Phase
HNSCC Drug: cetuximab Drug: Carboplatin, 5FU concomitant Radiation: Radiotherapy Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 406 participants
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
Study Start Date : February 2008
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 3 years ]

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


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

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

Responsible Party: Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier: NCT00609284     History of Changes
Other Study ID Numbers: GORTEC 2007-01
First Posted: February 7, 2008    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018

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

Additional relevant MeSH terms:
Carboplatin
Cetuximab
Antineoplastic Agents