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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier:
NCT01228565
First received: October 25, 2010
Last updated: January 2, 2014
Last verified: January 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Quality of life by the Dermatology Life Quality Index (DLQI)


Enrollment: 76
Study Start Date: August 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier: NCT01228565     History of Changes
Other Study ID Numbers: GORTEC 2009-01
Study First Received: October 25, 2010
Last Updated: January 2, 2014
Health Authority: France : Agence Française de Securite Sanitaire des Produits de Sante (AFSSAPS)

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

Additional relevant MeSH terms:
Carcinoma
Dermatitis
Radiodermatitis
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Skin Diseases
Radiation Injuries
Wounds and Injuries
Neoplasms, Squamous Cell
Neoplasms by Site
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014