Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux® (GORTEC 2009-01)
This study is currently recruiting participants.
Verified June 2011 by Groupe Oncologie Radiotherapie Tete et Cou
Sponsor:
Groupe Oncologie Radiotherapie Tete et Cou
Information provided by:
Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier:
NCT01228565
First received: October 25, 2010
Last updated: June 23, 2011
Last verified: June 2011
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Purpose
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+Ervitux+OTD70DERM® for the treatment of head and neck carcinoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Carcinoma |
Other: Radiotherapy + Erbitux® + placebo Other: Radiotherapy+Erbitux+OTD70DERM |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Placebo Controlled Randomized Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux® |
Resource links provided by NLM:
Further study details as provided by Groupe Oncologie Radiotherapie Tete et Cou:
Primary Outcome Measures:
- Radio-dermatitis grade 2, 3, 4 (NCI-CTC V3) [ Time Frame: 3 months ] [ Designated as safety issue: No ]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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]Quality of life by the Dermatology Life Quality Index (DLQI)
| Estimated Enrollment: | 70 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Radiotherapy+Erbitux+Placebo
|
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
|
|
Experimental: OTD70DERM
Radiotherapy+Erbitux+OTD70DERM®
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Head and neck carcinoma treated by radiotherapy (70Gy) plus Erbitux
Exclusion Criteria:
- IMRT; Concomitant chemotherapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228565
Contacts
| Contact: Jean Bourhis | jean.bourhis@igr.fr |
Locations
| France | |
| CHI Creteil | Recruiting |
| Creteil, France, 94010 | |
| Contact: Michel Martin | |
| Principal Investigator: Michel Martin | |
| Centre de Forcilles | Recruiting |
| Ferolles Attily, France, 77150 | |
| Contact: Nancy Moisy-Weber | |
| Principal Investigator: Nancy Moisy-Weber | |
| CLCC Nantes | Recruiting |
| Nantes, France, 44085 | |
| Contact: Etienne Bardet | |
| Principal Investigator: Etienne Bardet | |
| CHU Pitie Salpetriere | Recruiting |
| Paris, France, 75013 | |
| Contact: Philippe Lang | |
| Principal Investigator: Philippe Lang | |
| Institut Gustave Roussy | Recruiting |
| Villejuif, France, 94805 | |
| Contact: Jean Bourhis | |
| Principal Investigator: Jean Bourhis | |
Sponsors and Collaborators
Groupe Oncologie Radiotherapie Tete et Cou
More Information
Additional Information:
No publications provided
| Responsible Party: | Jean Bourhis / Professor, GORTEC |
| ClinicalTrials.gov Identifier: | NCT01228565 History of Changes |
| Other Study ID Numbers: | GORTEC 2009-01 |
| Study First Received: | October 25, 2010 |
| Last Updated: | June 23, 2011 |
| Health Authority: | France : Agence Française de Securite Sanitaire des Produits de Sante (AFSSAPS) |
Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou:
|
Head and neck carcinoma treated by radiotherapy plus erbitux |
Additional relevant MeSH terms:
|
Carcinoma Dermatitis Radiodermatitis Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Skin Diseases |
Radiation Injuries Wounds and Injuries Neoplasms, Squamous Cell Neoplasms by Site Cetuximab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013