We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01228565
First Posted: October 26, 2010
Last Update Posted: March 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Groupe Oncologie Radiotherapie Tete et Cou
  Purpose
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.

Condition Intervention Phase
Head and Neck Carcinoma Other: Radiotherapy + Erbitux® + placebo Other: Radiotherapy+Erbitux+OTD70DERM Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Placebo Controlled Randomized Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®

Resource links provided by NLM:


Further study details as provided by Groupe Oncologie Radiotherapie Tete et Cou:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Quality of life [ Time Frame: 3 months ]
    Quality of life by the Dermatology Life Quality Index (DLQI)


Enrollment: 76
Study Start Date: August 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Radiotherapy+Erbitux+Placebo
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
Experimental: OTD70DERM
Radiotherapy+Erbitux+OTD70DERM®
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • IMRT; Concomitant chemotherapy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01228565


Locations
France
CHI Creteil
Creteil, France, 94010
Centre de Forcilles
Ferolles Attily, France, 77150
CLCC Nantes
Nantes, France, 44085
CHU Pitie Salpetriere
Paris, France, 75013
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Groupe Oncologie Radiotherapie Tete et Cou
  More Information

Additional Information:
GORTEC  This link exits the ClinicalTrials.gov site

Responsible Party: Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier: NCT01228565     History of Changes
Other Study ID Numbers: GORTEC 2009-01
First Submitted: October 25, 2010
First Posted: October 26, 2010
Last Update Posted: March 24, 2015
Last Verified: March 2015

Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou:
Head and neck carcinoma treated by radiotherapy plus erbitux

Additional relevant MeSH terms:
Dermatitis
Radiodermatitis
Skin Diseases
Radiation Injuries
Wounds and Injuries
Cetuximab
Antineoplastic Agents


To Top