Radiotherapy in Association With Cetuximab in Patients Treated for an Epidermoid Cancer
- Conditions
- Epidermoid Head and Neck Cancer
- Interventions
- 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
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)
Clinique du Parc
🇫🇷Croix, France
Centre Leonard de Vinci
🇫🇷Douai, France
Centre Bourgogne
🇫🇷Lille, France
Centre Oscar Lambret
🇫🇷Lille, France
Centre Galilée
🇫🇷Lille, France
Centre Gray
🇫🇷Maubeuge, France
Centre Joliot Curie
🇫🇷Saint Martin Les Boulogne, France
Clinique du Parc🇫🇷Croix, France