Head and Neck Carcinoma
Conditions
Keywords
Head and neck carcinoma treated by radiotherapy plus erbitux
Brief summary
The aim of this randomized trial is to compare the rate of radio-dermatitis grade 2+ (NCI-CTC V3.0) in patients receiving radiotherapy+Erbitux+placebo versus in patients receiving radiotherapy+Erbitux+OTD70DERM® for the treatment of head and neck carcinoma.
Interventions
OTHERRadiotherapy + Erbitux® + placebo
3D radiotherapy 70 Gy / 7 weeks (no IRMT); Erbitux once a week, 1 week before radiotherapy and during radiotherapy ; Placebo local application, once a day, every day during the radiotherapy
OTHERRadiotherapy+Erbitux+OTD70DERM
3D radiotherapy 70 Gy / 7 weeks (no IRMT); Erbitux once a week, 1 week before radiotherapy and during radiotherapy ; OTD70DERM local application, once a day, every day during the radiotherapy
Sponsors
Groupe Oncologie Radiotherapie Tete et Cou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Head and neck carcinoma treated by radiotherapy (70Gy) plus Erbitux
Exclusion criteria
* IMRT; Concomitant chemotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radio-dermatitis grade 2, 3, 4 (NCI-CTC V3) | 3 months | Radio-dermatitis grade 2, 3, 4 (according to the NCI-CTC V3. Radio-dermatitis will be evaluated twice a week during radiotherapy and at M1, M2 and M3 after end of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 3 months | Quality of life by the Dermatology Life Quality Index (DLQI) |
Countries
France
Outcome results
None listed