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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT01280318
First received: January 19, 2011
Last updated: November 13, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Head and Neck Squamous Cell Carcinoma
Growth Factor
Surgery
Procedure: head and neck surgery
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Profile of Plasma Growth Factors Before and After Head and Neck Oncological or Non-oncological Surgery

Resource links provided by NLM:


Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Compare the results of group I with groups II and III [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: January 2009
Study Completion Date: September 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01280318

Locations
Belgium
Jean-Pascal Machiels
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Principal Investigator: Jean-Pascal Machiels, PhD Cliniques Universitaires St Luc-UCL
  More Information

No publications provided

Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01280318     History of Changes
Other Study ID Numbers: UCL-ONCO 2008-03, Academic study
Study First Received: January 19, 2011
Last Updated: November 13, 2012
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 20, 2014