NCT00918593

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Copenhagen University Hospital at Herlev · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

About 5 % of all cancer patients experience cutaneous metastases. Ulcerating metastases can be of great psychological distress for the patients and may also be painful. Radiation therapy is standard treatment for ulcerating metastases, but there are no reports of response rate. With this study we wish to compare electrochemotherapy with radiotherapy when treating ulcerated cutaneous metastases up to 5 cm in diameter from any kind of histology. Patient recruitment: 98 patients are to be recruited, the patients will be randomized between electrochemothreapy or radiotherapy. 49 patients will be treated in each arm. Treatment: Patients will be treated in local or general anesthesia (inhaling max. 30 % oxygen) Bleomycin will be given either intratumoral or intravenous. Electric pulses will be administered using a square wave electroporator (IGEA, Carpi, Italy). Needle and plate electrodes are used in order to treat the affected area efficiently. Eight pulses at a frequency of 5000 Hz or 1 Hz will be used for each application of the electrodes. In this way, a large area can be treated within a short time. Post treatment, the area will be covered by dry dressings, as are standardly used. The patients will be seen at 8, 30, 60, 90 and 180 days post treatment. Chest X ray will be taken before and after treatment for the patients receiving electrochemotherapy. Evaluation: Evaluation is performed by measurement of lesion extension and digital photography using the RECIST criteria. The first 10 patients in each treatment arm will also be PET/CT-scanned before and one week after treatment. Safety: Safety will be reported both in terms of evaluation of adverse events and in terms of patient satisfaction determined by questionnaire, including the 'Derriford Appearance Questionaire'.

Conditions

• Ulcerated Cutaneous Metastases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-12-01
• Primary completion: 2013-08-01
• Completion: 2014-02-01
• First posted: 2009-06-11
• Last updated: 2011-09-27

Locations

1 site across 1 country: Denmark