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Palliative Treatment of Ulcerated Cutaneous Metastases: Trial Between Electrochemotherapy and Radiotherapy

NCT00918593 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2011-09-27

No results posted yet for this study

Summary

By applying short electric pulses to cells, the cell membranes can become permeabilised (electroporation). This can be used augment the effect of chemotherapy, by providing direct access to the cell cytosol. For the drug bleomycin, the enhancement of effect is several hundred fold, enabling once-only treatment. The investigators wish compare electrochemotherapy with radiotherapy when treating ulcerated cutaneous metastases up to 5 cm in diameter from any kind of histology.

Conditions

  • Ulcerated Cutaneous Metastases

Interventions

DRUG

Electrochemotherapy

Intratumoral or intravenous bleomycin followed by electric pulses. Once only treatment.

RADIATION

Radiotherapy

Radiotherapy according to hospital procedures.

DRUG

Bleomycin

Intratumoral or intravenous bleomycin followed by electric pulses. Once only treatment.

Sponsors & Collaborators

  • Copenhagen University Hospital at Herlev

    lead OTHER

Principal Investigators

  • Julie Gehl, Consultant · Copenhagen University Hospital at Herlev

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2013-08-31
Completion
2014-02-28

Countries

  • Denmark

Study Locations

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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 NCT00918593 on ClinicalTrials.gov