Growth Factor, Head and Neck Squamous Cell Carcinoma, Surgery
Conditions
Brief summary
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
Interventions
PROCEDUREhead and neck surgery
Blood Sample of biomakers at 3 days, 5 weeks and 3 months after surgery.
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* Nasopharynx cancer * past or current malignancy other than HNSCC * performance ECOG status more than 2 * concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol * use of any investigational agents within 4 weeks prior to entry * Previous exposure to EGFR targeting therapy * known grade hypersensitivity to cetuximab * legal incapacity or limited legal capacity or medical or psychological condition which in the opiniion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Compare the results of group I with groups II and III | 5 months |
Countries
Belgium
Outcome results
None listed