Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Academic study |
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 obvious hypothesis is that the application of peri-operative targeted biological agents may counteract the tumor growth effect of these circulating factors and improve patient outcome
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | patients with operable head and neck squamous cell carcinoma |
|
| 2 | Other | patients treated by neck ansd head surgery for a non-oncological disease |
|
| 3 | Experimental | patients treated before surgery with 3 doses of neoadjuvant cetuximab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| head and neck surgery | Procedure | Blood Sample of biomakers at 3 days, 5 weeks and 3 months after surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| identification of the biomarkers could lead to the development of peri-operative targeted therapies to decrease the risk of local and distant tumor growth | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the results of group I with groups II and III | 5 months |
Not provided
Inclusion Criteria:
Age 18 years and over
_ histological proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharinx or larynx
Patients selected for a primary surgical treatment
no distant metastases
no active second malignancy during the last 5 years except non melanoma skin cancer or carcinoma in situ of the cervix
no prior or concurrent evidence of uncontrolled severe pathology precluding administration of surgery
life expectancy of more than 3 months
not pregnant or nursing; fertile patients both male and female, must use effective contraception
absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
signed informed consent
performance status ECOG 0-1
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jean-Pascal Machiels, PhD | Cliniques Universitaires St Luc-UCL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jean-Pascal Machiels | Brussels | 1200 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided