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

Phase 1

Completed

• Conditions: Surgery; Head and Neck Squamous Cell Carcinoma; Growth Factor
• Interventions: Procedure: head and neck surgery

• Registration Number: NCT01280318
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2011-01-19
• Study First Submitted QC: 2011-01-19
• Study First Posted: 2011-01-20
• Primary Completion: 2011-12
• Study Completion: 2012-09
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-13
• Last Update Posted: 2012-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	head and neck surgery	patients with operable head and neck squamous cell carcinoma
2	head and neck surgery	patients treated by neck ansd head surgery for a non-oncological disease
3	head and neck surgery	patients treated before surgery with 3 doses of neoadjuvant cetuximab

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Compare the results of group I with groups II and III	5 months

Trial Locations

Locations (1)

Jean-Pascal Machiels; 🇧🇪 Brussels, Belgium