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

November 13, 2012 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Jean-Pascal Machiels

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 5 months
5 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Jean-Pascal Machiels, PhD, Cliniques universitaires St Luc-UCL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

January 19, 2011

First Submitted That Met QC Criteria

January 19, 2011

First Posted (Estimate)

January 20, 2011

Study Record Updates

Last Update Posted (Estimate)

November 14, 2012

Last Update Submitted That Met QC Criteria

November 13, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCL-ONCO 2008-03
  • Academic study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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