Calcium Electroporation for Treatment of Cutaneous Metastases
|Cutaneous Metastases||Drug: Calcium electroporation Drug: Electrochemotherapy with bleomycin||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Calcium Electroporation for Treatment of Cutaneous Metastases|
- Tumor response [ Time Frame: After 6 months ]Response evaluated by "Response Evaluation Criteria in Solid Tumors" (RECIST) guidelines version 1.1.
- Adverse events to calcium electroporation [ Time Frame: After 6 months ]Describe adverse events using Common Terminology for Adverse Events, version 4.0
- Compare tumor response of calcium electroporation with tumor response of electroporation. Response is evaluated by RECIST criteria. [ Time Frame: After 6 months ]It is a non-inferiority study, and we accept a difference in response on 15%.
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||April 2018|
|Estimated Primary Completion Date:||April 2018 (Final data collection date for primary outcome measure)|
Experimental: Calcium electroporation
The metastases will be treated with intratumoral injection of calcium chlorid followed by electrotransfer.
It is a once-only treatment. Calcium chlorid concentration: 9mg/ml. Total dose: 0,5ml/cm3 tumor volume.
Drug: Calcium electroporation
Intratumoral injection, once only treatment.
Active Comparator: Electrochemotherapy with bleomycin
The metastases will be treated with intratumoral injection of bleomycin followed by electrotransfer.
It is a once only treatment. bleomycin concentration: 1000 IU/ml. Total dose: o,5 ml/cm3 tumor volume.
Drug: Electrochemotherapy with bleomycin
Intratumoral injection, once only treatment
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%.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01941901
|Contact: Julie Gehlfirstname.lastname@example.org|
|Department of Oncology, Copenhagen University Hospital, Herlev||Recruiting|
|Herlev, Denmark, 2730|
|Contact: Julie Gehl 004538683868 email@example.com|
|Principal Investigator: Julie Gehl|
|Principal Investigator:||Julie Gehl||Department of Oncology, Copenhagen University hospital, Herlev|