Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Radiotherapy+Erbitux+Placebo |
|
| OTD70DERM | Experimental | Radiotherapy+Erbitux+OTD70DERM® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy + Erbitux® + placebo | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Quality of life by the Dermatology Life Quality Index (DLQI) | 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHI Creteil | Créteil | 94010 | France | |||
| Centre de Forcilles |
Not provided
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Radiotherapy+Erbitux+OTD70DERM | Other | 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 |
|
| Ferolles Attily |
| 77150 |
| France |
| CLCC Nantes | Nantes | 44085 | France |
| CHU Pitie Salpetriere | Paris | 75013 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| D007136 |
| Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |