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
About this trial
This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma
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.
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
NCT ID
NCT01280318
First Posted
January 19, 2011
Last Updated
November 13, 2012
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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
Learn more about this trial
Profile of Plasma Growth Factors Before and After Head and Neck Oncological or Non-oncological Surgery
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