Phase 2
N=23
Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II
Liver Metastases
Bottom Line
View on ClinicalTrials.gov: NCT02352259 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Evaluation of Safety Related to Electrochemotherapy — 20; 3; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Electrochemotherapy (Procedure); Cliniporator Vitae® (Device); Bleomycin PHC 15 e. (United States Pharmacopeia - USP) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Institute of Oncology Ljubljana
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluation of Safety Related to Electrochemotherapy |
20; 3; 0; 0 | — |
| SECONDARY Response to Treatment (Determined by Modified RECIST Criteria). |
10; 4; 9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Histologically and/or cytologically confirmed colorectal cancer.
- Age over 18.
- Life expectancy more than 3 month.
- Performance status Karnofsky ≥ 70 or (World Health Organization) WHO ≤ 2.
- Chemotherapy free interval 2-5 weeks, depending on the drugs used.
- Patient must be mentally capable of understanding the information given.
- Patient must give informed consent.
- Patient must be discussed at the multidisciplinary team for tumors of the gastrointestinal tract before entering the trial.
Exclusion Criteria
- Secondary primary tumor, except surgically treated noninvasive cancer of cervix, or surgically or irradiated basal cell carcinoma
- Visceral, bone or diffuse metastases.
- Life-threatening infection and/or heart failure and/or liver failure and/or other severe systemic pathologies.
- Clinically significant ascites.
- Significant reduction in respiratory function.
- Age less than 18 years.
- Coagulation disturbances.
- Cumulative dose of 250 mg/m2 bleomycin received.
- Allergic reaction to bleomycin.
- Impaired kidney function (creatinin > 150 µmol/l).
- Patients with epilepsy.
- Patients with arrhythmias.
- Patients with pacemaker or defibrillator.
- Pregnancy.
- Patient incapable of understanding the aim of the study or disagree with the entering into the clinical study.
Data sourced from ClinicalTrials.gov (NCT02352259). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.