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Trial Title:
Real-time Margin Assessment in Head and Neck Cancer
NCT ID:
NCT05499065
Condition:
Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Cetuximab
Conditions: Keywords:
Cetuximab-800CW
Fluorescence guided surgery
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Fluorescence guided detection of tumor positive margins
Description:
To test if the fluorescence can guide the location for fresh frozen section sampling
intra-operatively
Arm group label:
75mg cetuximab + 15mg cetuximab-800CW
Intervention type:
Drug
Intervention name:
Cetuximab-IRDye800
Description:
Administrate 75mg cetuximab + 15mg cetuximab-800CW for fluorescence visualization
Arm group label:
75mg cetuximab + 15mg cetuximab-800CW
Summary:
To investigate if the combination of fresh frozen sectioning based on cetuximab-800CW can
enhance tumor-positive margin detection intra-operatively.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Cytology and/or histology-confirmed diagnosis of oral squamous cell carcinoma and
scheduled to undergo surgical removal as decided by the multidisciplinary head and
neck tumor board of the UMCG;
- Age ≥ 18 years;
- Written informed consent.
Exclusion Criteria:
- Medical or psychiatric conditions that compromise the patient's ability to give
informed consent;
- Concurrent uncontrolled medical conditions;
- Received an investigational drug within 30 days prior to the dose of
cetuximab-800CW;
- History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac
heart failure, significant liver disease (ALT >3X upper limits of normal or
increased total bilirubin) or unstable angina within 6 months prior to enrollment;
- Inadequately controlled hypertension with or without current antihypertensive
medications;
- History of allergy or infusion reactions cetuximab or other monoclonal antibody
therapies;
- Pregnant or lactating women. Documentation of a negative pregnancy test must be
available for women of childbearing potential. Moreover, the need to be willing to
ensure that she or her partner uses effective contraception during the trial and for
6 months thereafter. Woman of childbearing potential are premenopausal women with
intact reproductive organs and women less than two years after menopause;
- Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or
greater than 450 ms in females)
- Patients receiving Class 1a (quinidine, procainamide) or Class III (dofetilide,
amiodarone, sotalol) antiarrhythmic agents.
- Life expectancy < 12 weeks;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Medical Center Groningen
Address:
City:
Groningen
Zip:
9713 GZ
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Max JH Witjes, MD, PhD
Phone:
+31-50-3616161
Email:
m.j.h.witjes@umcg.nl
Contact backup:
Last name:
Floris J Voskuil, MD, PhD
Phone:
+31-50-3616161
Email:
f.j.voskuil@umcg.nl
Start date:
March 1, 2023
Completion date:
January 10, 2025
Lead sponsor:
Agency:
University Medical Center Groningen
Agency class:
Other
Source:
University Medical Center Groningen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05499065
