Spots Global Cancer Trial Database for Calcium Electroporation for Treatment of Cutaneous Metastases
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Trial Identification
Brief Title: Calcium Electroporation for Treatment of Cutaneous Metastases
Official Title: Calcium Electroporation for Treatment of Cutaneous Metastases
Study ID: NCT01941901
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate the effect of calcium electroporation on cutaneous metastases, and compare calcium electroporation with standard treatment: electrochemotherapy.
Detailed Description: Double-blinded phase II clinical study. We will compare the effect of calcium electroporation for the treatment of cutaneous metastases with standard treatment: electrochemotherapy with intratumoral injection of bleomycin. Separate randomisation will be performed and the lesions will be treated with either intratumoral injection of calcium or bleomycin. It is a once only treatment and the patients will be followed up for 6 months. It is a non-inferiority study and we accept a difference in response on 15%.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Department of Oncology, Copenhagen University Hospital, Herlev, Herlev, , Denmark
Contact Details
Name: Julie Gehl
Affiliation: Department of Oncology, Copenhagen University hospital, Herlev
Role: PRINCIPAL_INVESTIGATOR
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