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

• Conditions: Epidermoid Head and Neck Cancer
• Interventions: Drug: Cetuximab; Radiation: Radiotherapy

• Registration Number: NCT01647555
• Lead Sponsor: Centre Oscar Lambret

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2012-05
• Study First Submitted: 2012-07-19
• Study First Submitted QC: 2012-07-20
• Study First Posted: 2012-07-23
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-22
• Last Update Posted: 2014-08-25
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patient with epidermoid cancer	Cetuximab	receiving Cetuximab and radiotherapy
patient with epidermoid cancer	Radiotherapy	receiving Cetuximab and radiotherapy

Primary Outcome Measures

Name	Time	Method
Skin toxicities	until week 38	according to NCI-CTCAE version 3.0

Secondary Outcome Measures

Name	Time	Method
Quality of life	baseline, week 4, month 6	Questionnaire QLQ-C30
Healthcare and evolution of skin toxicities	until week 38	Treatment of skin toxicities, according to sponsor advices.
tumoral efficacy	6 months after treatment	According to RECIST criteria

Trial Locations

Locations (7)

Centre Bourgogne; 🇫🇷 Lille, France

Centre Joliot Curie; 🇫🇷 Saint Martin Les Boulogne, France

Centre Gray; 🇫🇷 Maubeuge, France

Clinique du Parc; 🇫🇷 Croix, France

Centre Leonard de Vinci; 🇫🇷 Douai, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre Galilée; 🇫🇷 Lille, France