We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT01228565
Recruitment Status : Completed
First Posted : October 26, 2010
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Groupe Oncologie Radiotherapie Tete et Cou

Tracking Information
First Submitted Date  ICMJE October 25, 2010
First Posted Date  ICMJE October 26, 2010
Last Update Posted Date March 24, 2015
Study Start Date  ICMJE August 2010
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2010)
Quality of life [ Time Frame: 3 months ]
Quality of life by the Dermatology Life Quality Index (DLQI)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®
Official Title  ICMJE Placebo Controlled Randomized Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Head and Neck Carcinoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Radiotherapy+Erbitux+Placebo
    Intervention: Other: Radiotherapy + Erbitux® + placebo
  • Experimental: OTD70DERM
    Radiotherapy+Erbitux+OTD70DERM®
    Intervention: Other: Radiotherapy+Erbitux+OTD70DERM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 2, 2014)
76
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2010)
70
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • IMRT; Concomitant chemotherapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01228565
Other Study ID Numbers  ICMJE GORTEC 2009-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Groupe Oncologie Radiotherapie Tete et Cou
Original Responsible Party Jean Bourhis / Professor, GORTEC
Current Study Sponsor  ICMJE Groupe Oncologie Radiotherapie Tete et Cou
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Groupe Oncologie Radiotherapie Tete et Cou
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP