Clinical trial · Interventional
Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®
Placebo Controlled Randomized Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®
NCT01228565CI-TRIAL-00017208GORTEC 2009-01completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Carcinoma | Head and Neck Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy+Erbitux+OTD70DERM | Other | — | UNRESOLVED |
| Radiotherapy + Erbitux® + placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Radiotherapy+Erbitux+Placebo
- interventionNames
- Other: Radiotherapy + Erbitux® + placebo
- type
- EXPERIMENTAL
- label
- OTD70DERM
- description
- Radiotherapy+Erbitux+OTD70DERM®
- interventionNames
- Other: Radiotherapy+Erbitux+OTD70DERM
Primary outcomes (1)
- measure
- Radio-dermatitis grade 2, 3, 4 (NCI-CTC V3)
- timeFrame
- 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Head and neck carcinoma treated by radiotherapy (70Gy) plus Erbitux Exclusion Criteria: * IMRT; Concomitant chemotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.