GORTEC 2009-01: Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®
Sponsor
Groupe Oncologie Radiotherapie Tete et Cou (Other)
Overall Status
Completed
CT.gov ID
NCT01228565
Collaborator
(none)
76
5
2
45
15.2
0.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Placebo Controlled Randomized Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®
Study Start Date
:
Aug 1, 2010
Actual Primary Completion Date
:
May 1, 2014
Actual Study Completion Date
:
May 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Radio-dermatitis grade 2, 3, 4 (NCI-CTC V3) [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.
Secondary Outcome Measures
- Quality of life [3 months]
Quality of life by the Dermatology Life Quality Index (DLQI)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Head and neck carcinoma treated by radiotherapy (70Gy) plus Erbitux
Exclusion Criteria:
- IMRT; Concomitant chemotherapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHI Creteil | Creteil | France | 94010 | |
| 2 | Centre de Forcilles | Ferolles Attily | France | 77150 | |
| 3 | CLCC Nantes | Nantes | France | 44085 | |
| 4 | CHU Pitie Salpetriere | Paris | France | 75013 | |
| 5 | Institut Gustave Roussy | Villejuif | France | 94805 |
Sponsors and Collaborators
- Groupe Oncologie Radiotherapie Tete et Cou
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier:
NCT01228565
Other Study ID Numbers:
- GORTEC 2009-01
First Posted:
Oct 26, 2010
Last Update Posted:
Mar 24, 2015
Last Verified:
Mar 1, 2015
Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou
Additional relevant MeSH terms: