Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®

Groupe Oncologie Radiotherapie Tete et Cou76 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Head and Neck Carcinoma

Interventions

Radiotherapy + Erbitux® + placeboOTHER

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

Radiotherapy+Erbitux+OTD70DERMOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Head and neck carcinoma treated by radiotherapy (70Gy) plus Erbitux Exclusion Criteria: * IMRT; Concomitant chemotherapy

Locations (5)

CHI Creteil

Créteil, France

Centre de Forcilles

Ferolles Attily, France

CLCC Nantes

Nantes, France

CHU Pitie Salpetriere

Paris, France

Institut Gustave Roussy

Villejuif, France

Outcomes

Primary Outcomes

Radio-dermatitis grade 2, 3, 4 (NCI-CTC V3)

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.

Time frame: 3 months

Secondary Outcomes

Quality of life

Quality of life by the Dermatology Life Quality Index (DLQI)

Time frame: 3 months

Data from ClinicalTrials.gov

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