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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00609284
Other study ID # GORTEC 2007-01
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 15, 2008
Est. completion date March 26, 2019

Study information

Verified date April 2020
Source Groupe Oncologie Radiotherapie Tete et Cou
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 406
Est. completion date March 26, 2019
Est. primary completion date March 26, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • HNSCC
  • Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
cetuximab
D-7, D1, D8, D15, D22, D29, D43, D50
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

Locations

Country Name City State
France Centre hospitalier Annecy Annecy
France Centre Jean Perrin Clermont Ferrand
France Centre Guillaume Le Conquerant Le Havre
France Centre hospitalier de Bretagne Sud Lorient
France Institut Gustave Roussy Villejuif

Sponsors (1)

Lead Sponsor Collaborator
Groupe Oncologie Radiotherapie Tete et Cou

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression free survival 3 years
Secondary Loco-regional control 3 years
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