Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®
NCT ID: NCT01228565
Last Updated: 2015-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
76 participants
INTERVENTIONAL
2010-08-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo
Radiotherapy+Erbitux+Placebo
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
OTD70DERM
Radiotherapy+Erbitux+OTD70DERM®
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
Interventions
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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
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 Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Groupe Oncologie Radiotherapie Tete et Cou
OTHER
Responsible Party
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Locations
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CHI Creteil
Créteil, , France
Centre de Forcilles
Ferolles Attily, , France
CLCC Nantes
Nantes, , France
CHU Pitie Salpetriere
Paris, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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GORTEC 2009-01
Identifier Type: -
Identifier Source: org_study_id
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