Profile of Plasma Growth Factors Before and After Head and Neck Oncological or Non-oncological Surgery

Study Overview
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Brief Summary
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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

Official Title
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Profile of Plasma Growth Factors Before and After Head and Neck Oncological or Non-oncological Surgery

Conditions
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Head and Neck Squamous Cell Carcinoma, Growth Factor, Surgery

Intervention / Treatment
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* Procedure: head and neck surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>patients with operable head and neck squamous cell carcinoma | Procedure: head and neck surgery<br>* Blood Sample of biomakers at 3 days, 5 weeks and 3 months after surgery.<br>|
| Other: 2<br>patients treated by neck ansd head surgery for a non-oncological disease | Procedure: head and neck surgery<br>* Blood Sample of biomakers at 3 days, 5 weeks and 3 months after surgery.<br>|
| Experimental: 3<br>patients treated before surgery with 3 doses of neoadjuvant cetuximab | Procedure: head and neck surgery<br>* Blood Sample of biomakers at 3 days, 5 weeks and 3 months after surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the results of group I with groups II and III |  | 5 months |