drugset / Trial / NCT02352259
Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II
Phase 2
Completed
23 enrolled
Institute of Oncology Ljubljana
University Medical Centre Ljubljana · collabUniversity Medical Centre Maribor · collabUniversity of Ljubljana · collab
NaSingle-groupOpen-labelTreatment
Summary
The study is prospective, phase II study, The primary objective of the study is evaluation of the feasibility and safety of intraoperative electrochemotherapy of colorectal liver metastases. The secondary objective is to determine the efficacy of electrochemotherapy treatment, based on histological and radiological evaluation of treated metastases. The endpoints are: toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) ver. 4.0 and response rate measured by percentage of vital tumor cells and mRECIST criteria.
Timeline
- Start
- 2013-09
- Primary completion
- 2018-10
- Completion
- 2018-10
Publications
- Background Edhemovic I, Brecelj E, Gasljevic G, Marolt Music M, Gorjup V, Mali B, Jarm T, Kos B, Pavliha D, Grcar Kuzmanov B, Cemazar M, Snoj M, Miklavcic D, Gadzijev EM, Sersa G. Intraoperative electrochemotherapy of colorectal liver metastases. J Surg Oncol. 2014 Sep;110(3):320-7. doi: 10.1002/jso.23625. Epub 2014 Apr 30.
- Background Edhemovic I, Gadzijev EM, Brecelj E, Miklavcic D, Kos B, Zupanic A, Mali B, Jarm T, Pavliha D, Marcan M, Gasljevic G, Gorjup V, Music M, Vavpotic TP, Cemazar M, Snoj M, Sersa G. Electrochemotherapy: a new technological approach in treatment of metastases in the liver. Technol Cancer Res Treat. 2011 Oct;10(5):475-85. doi: 10.7785/tcrt.2012.500224.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bleomycin | Unknown | 15 mg/m2 | Intravenous |