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Electrochemotherapy on Head and Neck Cancer

NCT02549742 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-01-18

No results posted yet for this study

Summary

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.

Conditions

  • Head Neck Cancer

Interventions

PROCEDURE

Electrochemotherapy

Electroporation by a device, Cliniporator, combined with chemotherapy, Bleomycin.

DEVICE

Cliniporator

Electric pulses , duration 100 microseconds, about 400 V given at 5000 Hz.

DRUG

Bleomycin

Administered intravenously or injected into the tumour before electroporation.

Sponsors & Collaborators

  • Copenhagen University Hospital at Herlev

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Julie Gehl, MD · Denmark: Herlev and Gentofte Hospital, University of Copenhagen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02549742 on ClinicalTrials.gov