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

Primary Purpose

Head and Neck Squamous Cell Carcinoma, Growth Factor, Surgery

Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
head and neck surgery
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jean-Pascal Machiels

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Experimental

Arm Label

1

2

3

Arm Description

patients with operable head and neck squamous cell carcinoma

patients treated by neck ansd head surgery for a non-oncological disease

patients treated before surgery with 3 doses of neoadjuvant cetuximab

Outcomes

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

Secondary Outcome Measures

Compare the results of group I with groups II and III

Full Information

First Posted
January 19, 2011
Last Updated
November 13, 2012
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT01280318
Brief Title
Profile of Plasma Growth Factors Before and After Head and Neck Oncological or Non-oncological Surgery
Acronym
HNSCC
Official Title
Profile of Plasma Growth Factors Before and After Head and Neck Oncological or Non-oncological Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma, Growth Factor, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
patients with operable head and neck squamous cell carcinoma
Arm Title
2
Arm Type
Other
Arm Description
patients treated by neck ansd head surgery for a non-oncological disease
Arm Title
3
Arm Type
Experimental
Arm Description
patients treated before surgery with 3 doses of neoadjuvant cetuximab
Intervention Type
Procedure
Intervention Name(s)
head and neck surgery
Intervention Description
Blood Sample of biomakers at 3 days, 5 weeks and 3 months after surgery.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Compare the results of group I with groups II and III
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pascal Machiels, PhD
Organizational Affiliation
Cliniques Universitaires St Luc-UCL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jean-Pascal Machiels
City
Brussels
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

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

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