This trial is active, not recruiting.

Condition hnscc
Treatments cetuximab, carboplatin, 5fu concomitant, radiotherapy
Phase phase 3
Target EGFR
Sponsor Groupe Oncologie Radiotherapie Tete et Cou
Start date February 2008
End date February 2017
Trial size 406 participants
Trial identifier NCT00609284, GORTEC 2007-01


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Radiotherapy 70Gy, Erbitux, Carboplatin-5FU
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
70 Gy in 7 weeks
(Active Comparator)
Radiotherapy 70Gy, Erbitux
D-7, D1, D8, D15, D22, D29, D43, D50
70 Gy in 7 weeks

Primary Outcomes

Progression free survival
time frame: 3 years

Secondary Outcomes

Loco-regional control
time frame: 3 years

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Groupe Oncologie Radiotherapie Tete et Cou.