CETUXIMAB for Unknown primary tumour of the head and neck

Inclusion criteria

• {"criterion_text":"- Cytology and/or histology-confirmed diagnosis of squamous cell carcinoma most likely originating from the head & neck area and scheduled to undergo endoscopy of the upper aerodigestive tract as decided by the multidisciplinary head and neck tumor board of the UMCG\n- The primary tumor was not identified during standard diagnostic work-up in the outpatient clinic including physical head and neck examination, fiberoptic laryngoscopy, chest X-ray, CT and PET/CT\n- Age ≥ 18 years\n- Written informed consent"}

Exclusion criteria

• {"criterion_text":"- Medical or psychiatric conditions that compromise the patient’s ability to give informed consent\n- Life expectancy < 12 weeks\n- Karnofsky performance status < 70%\n- Concurrent uncontrolled medical conditions\n- Received an investigational drug within 30 days prior to the dose of cetuximab-800CW\n- 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\n- Inadequately controlled hypertension with or without current antihypertensive medications\n- History of allergy or infusion reactions cetuximab or other monoclonal antibody therapies\n- 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\n- Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)\n- Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents"}

Primary endpoints

• {"endpoint_text":"- Macroscopic fluorescent signal levels and tracer distribution observed with TFE","definition_or_measurement_approach":"Observed with TFE (targeted fluorescence endoscopy) as stated in the endpoint."}
• {"endpoint_text":"- Detection rates of TFE and WLE","definition_or_measurement_approach":"Detection rates measured for targeted fluorescence endoscopy (TFE) and white light endoscopy (WLE) as stated in the endpoint."}

Secondary endpoints

• {"endpoint_text":"- Patient characteristics (age, sex, BMI, history and morbidity, localization of primary tumor and lymph node metastasis, vital parameters and presence of symptoms before and after tracer administration)","definition_or_measurement_approach":"As described: collection of patient characteristics including age, sex, BMI, history, tumor localization, vital parameters and symptoms before/after tracer administration."}
• {"endpoint_text":"- Macroscopic fluorescent signal levels and tracer distribution observed with flexible fluorescence laryngoscopy","definition_or_measurement_approach":"Observed with flexible fluorescence laryngoscopy as stated."}
• {"endpoint_text":"- Quantification of intrinsic fluorescence signals observed using the MDSFR/SFF probe","definition_or_measurement_approach":"Quantification using the MDSFR/SFF probe as stated."}
• {"endpoint_text":"- Macroscopic fluorescent signal levels and tracer distribution observed with ex vivo imaging of FSA and mucosectomy specimens","definition_or_measurement_approach":"Observed with ex vivo imaging of FSA and mucosectomy specimens as stated."}
• {"endpoint_text":"- Histopathologic characteristics of biopsied specimens including HPV-status","definition_or_measurement_approach":"Assessment of histopathologic characteristics of biopsies, including HPV status, as stated."}
• {"endpoint_text":"- Results of the quality of life questionnaires QLQ-C30, QLQH&N35 and SWAL-QOL","definition_or_measurement_approach":"Results obtained from the specified QoL questionnaires (QLQ-C30, QLQH&N35 and SWAL-QOL) as stated."}

Netherlands

Earliest CTIS Part Ii Submission Date

29-10-2024

Latest Decision Or Authorization Date

08-11-2024

Processing Time Days

10

Number Of Sites

1

Number Of Participants

35

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands