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

Surgery Clinical Trial

— HNSCC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01280318
• Other study ID #: UCL-ONCO 2008-03
• Secondary ID: Academic study
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 19, 2011
• Last updated: November 13, 2012
• Start date: January 2009
• Est. completion date: September 2012

Study information

• Verified date: November 2012
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Growth Factor
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma
• Surgery

Intervention

Procedure:
• head and neck surgery
Blood Sample of biomakers at 3 days, 5 weeks and 3 months after surgery.

Locations

Country	Name	City	State
Belgium	Jean-Pascal Machiels	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Compare the results of group I with groups II and III		5 months	Yes