Radiotherapy in Association With Cetuximab in Patients Treated for an Epidermoid Cancer

Centre Oscar Lambret57 enrolled

Overview

This study evaluates the skin toxicities in patients with epidermoid cancer, treated by Radiotherapy in association with Cetuximab.

This prospective and multicentric study evaluates the skin toxicities in patients with locally Advanced head and neck epidermoid cancer, treated by Radiotherapy in association with Cetuximab.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Epidermoid Head and Neck Cancer

Interventions

CetuximabDRUG

First cycle: 400 mg/m2 Next cycles: 250 mg/m2

RadiotherapyRADIATION

Curative dose: 66 to 70 Gy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \> 18 years * Epidermoid head and neck carcinoma locally advanced * Indication of Cetuximab and radiotherapy * Karnofsky \>= 60 * Patients participating to another compatible study could be included after consultation with the study director Patients could be beforehand treated for an other ORL cancer The radiotherapy will be delivered for curative aim (minimal dose 66 Gy) Exclusion Criteria: * other histology * Metastatic disease * Recurrent patients

Locations (7)

Clinique du Parc

Croix, France

Centre Leonard de Vinci

Douai, France

Centre Bourgogne

Lille, France

Centre Oscar Lambret

Lille, France

Outcomes

Primary Outcomes

Skin toxicities

according to NCI-CTCAE version 3.0

Time frame: until week 38

Secondary Outcomes

Healthcare and evolution of skin toxicities

Treatment of skin toxicities, according to sponsor advices.

Time frame: until week 38

Quality of life reporting

Questionnaire QLQ-C30

Time frame: baseline, week 4, month 6

tumoral efficacy

According to RECIST criteria

Time frame: 6 months after treatment

Data from ClinicalTrials.gov

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