NCT01228565

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Groupe Oncologie Radiotherapie Tete et Cou · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Carcinoma

Interventions

Type	Name	Description
OTHER	Radiotherapy + 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
OTHER	Radiotherapy+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

Timeline

• Start date: 2010-08-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2010-10-26
• Last updated: 2015-03-24

Locations

5 sites across 1 country: France