Head Neck Cancer Clinical Trial
Official title:
Electrochemotherapy on Head and Neck Cancer
A phase II clinical trial testing electrochemotherapy on mucosal recurrent head and neck cancer. Twenty-five patients will be treated. Primary outcome is tumour response on imaging. Secondary outcomes are response from tissue samples, VAS score, Quality of life evaluation and side effects to treatment.
Electric pulses may be used to transiently permeabilise cell membranes, enabling passage of
otherwise non-permeating molecules. This dramatically enhances the cytotoxic effect of
certain chemotherapeutic agents, and is termed electrochemotherapy. Electrochemotherapy is
now standardly used in the treatment of cutaneous metastases of various cancers in over 100
cancer centers around Europe.
The intention of this trial is to investigate the possible use of electrochemotherapy in
recurrent head and neck cancer as a palliative treatment. Surgery and radiotherapy, with the
possible addition of chemotherapy, cures a large part of patients with head and neck cancer.
However, in the event of recurrence curative options may be exhausted and the patient is
referred for palliative chemotherapy.
It is for this patient group, the investigators propose electrochemotherapy in a clinical
trial.
The electrochemotherapy is administered as a once-only treatment, with possible retreatment
after eight weeks. Under general anesthesia, chemotherapy is administered intravenously,
followed by application of electric pulses to the tumour area. Before treatment, the
location and spread of the tumour is determined by imaging.
The trial includes evaluation of response by MRI (magnetic resonance imaging) and PET/CT
(Positron Emission Tomography - Computed Tomography) scans (base-line, 4 weeks, 8 weeks),
tissue samples, as well as adverse events registration and questionnaires on quality of
life. The planned study is a phase II clinical study, prospective, observational with up to
25 patients.
Treatments will be performed in collaboration between the Department of Oncology, Copenhagen
University Hospital Herlev, which has extensive experience in electrochemotherapy, and the
Department of Ear Nose and Throat Surgery at Copenhagen University Hospital Rigshospitalet,
that has the surgical expertise and set-up needed.
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