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Completed

NCT Number: NCT01228565

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

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.

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Key information

Conditions

Head and Neck Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHI Creteil, Créteil, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • IMRT; Concomitant chemotherapy

Treatment and study plan

Radiotherapy + Erbitux® + placebo

Other

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+OTD70DERM

Other

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. Quality of life

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Groupe Oncologie Radiotherapie Tete et Cou

Other

Registry information

Official study title

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

Acronym: GORTEC 2009-01

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Oct 26, 2010
Registry last updated
Mar 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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