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

Primary Purpose

Head and Neck Carcinoma

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Radiotherapy + Erbitux® + placebo
Radiotherapy+Erbitux+OTD70DERM
Sponsored by
Groupe Oncologie Radiotherapie Tete et Cou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Head and Neck Carcinoma focused on measuring Head and neck carcinoma treated by radiotherapy plus erbitux

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • IMRT; Concomitant chemotherapy

Sites / Locations

  • CHI Creteil
  • Centre de Forcilles
  • CLCC Nantes
  • CHU Pitie Salpetriere
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

OTD70DERM

Arm Description

Radiotherapy+Erbitux+Placebo

Radiotherapy+Erbitux+OTD70DERM®

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 25, 2010
Last Updated
March 23, 2015
Sponsor
Groupe Oncologie Radiotherapie Tete et Cou
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1. Study Identification

Unique Protocol Identification Number
NCT01228565
Brief Title
Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®
Acronym
GORTEC 2009-01
Official Title
Placebo Controlled Randomized Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Oncologie Radiotherapie Tete et Cou

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Carcinoma
Keywords
Head and neck carcinoma treated by radiotherapy plus erbitux

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Radiotherapy+Erbitux+Placebo
Arm Title
OTD70DERM
Arm Type
Experimental
Arm Description
Radiotherapy+Erbitux+OTD70DERM®
Intervention Type
Other
Intervention Name(s)
Radiotherapy + Erbitux® + placebo
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Radiotherapy+Erbitux+OTD70DERM
Intervention Description
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 Outcome Measure Information:
Title
Radio-dermatitis grade 2, 3, 4 (NCI-CTC V3)
Description
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 Outcome Measure Information:
Title
Quality of life
Description
Quality of life by the Dermatology Life Quality Index (DLQI)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Head and neck carcinoma treated by radiotherapy (70Gy) plus Erbitux Exclusion Criteria: IMRT; Concomitant chemotherapy
Facility Information:
Facility Name
CHI Creteil
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre de Forcilles
City
Ferolles Attily
ZIP/Postal Code
77150
Country
France
Facility Name
CLCC Nantes
City
Nantes
ZIP/Postal Code
44085
Country
France
Facility Name
CHU Pitie Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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