Electrochemotherapy in head and neck cancer patients

Completed

• Conditions: head and neck cancer; 10038666; 10019190

• Registration Number: NL-OMON36446
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

Biopsy confirmed malignancy of mucosa or skin
Accessibility of the entire tumor (with 0.5 cm margins) for the applicator with electrode array all directions
Creatinine level < 150 µmol/l

Exclusion Criteria

Tumors that involve a 50% or greater encasement of a blood vessel as measured by MRI or CT scan
Tumors having bone invasion
Hypersensitivity to Bleomycin
Subjects who have received or will exceed a total lifetime dose of Bleomycin greater than 400.000 IUg/m2
Subjects deemed unsuitable for general anesthesia and local anesthesia is not possible.
Subjects with pulmonary fibrosis.
Subjects with indwelling cardiac pacemakers who cannot tolerate a period with pacemaker turned off
Subjects with a history of uncontrolled cardiac arrhythmia
Women who are pregnant, or are nursing

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Treatment response</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Adverse effects and serious adverse events and quality of life</p><br>