Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux® (GORTEC 2009-01)

Groupe Oncologie Radiotherapie Tete et Cou

Status and phase: Completed; Phase 3

Conditions: Head and Neck Carcinoma

Treatments: Other: Radiotherapy+Erbitux+OTD70DERM; Other: Radiotherapy + Erbitux® + placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01228565

GORTEC 2009-01

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Head and neck carcinoma treated by radiotherapy (70Gy) plus Erbitux

Exclusion criteria

• IMRT; Concomitant chemotherapy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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76 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Radiotherapy+Erbitux+Placebo

Treatment:

Other: Radiotherapy + Erbitux® + placebo

OTD70DERM

Experimental group

Description:

Radiotherapy+Erbitux+OTD70DERM®

Treatment:

Other: Radiotherapy+Erbitux+OTD70DERM