Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®
GORTEC 2009-01
Placebo Controlled Randomized Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®
1 other identifier
interventional
76
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2010
Typical duration for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 25, 2010
CompletedFirst Posted
Study publicly available on registry
October 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedMarch 24, 2015
March 1, 2015
3.8 years
October 25, 2010
March 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 months
Secondary Outcomes (1)
Quality of life
3 months
Study Arms (2)
Placebo
PLACEBO COMPARATORRadiotherapy+Erbitux+Placebo
OTD70DERM
EXPERIMENTALRadiotherapy+Erbitux+OTD70DERM®
Interventions
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
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 Criteria
You may qualify if:
- Head and neck carcinoma treated by radiotherapy (70Gy) plus Erbitux
You may not qualify if:
- IMRT; Concomitant chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
CHI Creteil
Créteil, 94010, France
Centre de Forcilles
Ferolles Attily, 77150, France
CLCC Nantes
Nantes, 44085, France
CHU Pitie Salpetriere
Paris, 75013, France
Institut Gustave Roussy
Villejuif, 94805, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2010
First Posted
October 26, 2010
Study Start
August 1, 2010
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
March 24, 2015
Record last verified: 2015-03