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

Groupe Oncologie Radiotherapie Tete et Cou406 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

406

Conditions

HNSCC

Interventions

cetuximabDRUG

D-7, D1, D8, D15, D22, D29, D43, D50

Carboplatin, 5FU concomitantDRUG

Carboplatin 70mg/m²/D ; 5FU 600 mg/m²/D, D1-4, D22-25, D43-46

RadiotherapyRADIATION

70 Gy in 7 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (5)

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

Outcomes

Primary Outcomes

Progression free survival

Time frame: 3 years

Secondary Outcomes

Loco-regional control

Time frame: 3 years

Data from ClinicalTrials.gov

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