Placebo Controlled Randomized Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Carcinoma
Both
Head and Neck Carcinoma
Trial Information
Placebo Controlled Randomized Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®
Inclusion Criteria:
- Head and neck carcinoma treated by radiotherapy (70Gy) plus Erbitux
Exclusion Criteria:
- IMRT; Concomitant chemotherapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
Radio-dermatitis grade 2, 3, 4 (NCI-CTC V3)
Outcome Description:
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.
Outcome Time Frame:
3 months
Safety Issue:
No
Authority:
France : Agence Française de Securite Sanitaire des Produits de Sante (AFSSAPS)
Study ID:
GORTEC 2009-01
NCT ID:
NCT01228565
Start Date:
August 2010
Completion Date:
June 2012
Related Keywords:
- Head and Neck Carcinoma
- Head and neck carcinoma treated by radiotherapy plus erbitux
- Carcinoma
- Dermatitis
- Radiodermatitis
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
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