Skip to main content
OpenTrials
Completed

NCT Number: NCT01280318

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Jean-Pascal Machiels

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

head and neck surgery

Procedure

Blood Sample of biomakers at 3 days, 5 weeks and 3 months after surgery.

Primary outcomes

  1. 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

Secondary outcomes

  1. Compare the results of group I with groups II and III

    Time frame: 5 months

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Acronym: HNSCC

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jan 20, 2011
Registry last updated
Nov 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.