- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02352259
Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II
Study Overview
Status
Conditions
Detailed Description
The study is an extension of previously concluded and published study on electrochemotherapy of colorectal liver metastases (Edhemovic et al. JSO 2014). In this extension 15 patients will be included. Four groups of patients will be included. The patients from groups 1 and 2 are patients with up to 3 unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods due to the close proximity of major blood vessels. Electrochemotherapy will be offered to these patients as the only treatment option. In case of multiple, both resectable and non-resectable liver metastases, the latter will be treated with electrochemotherapy, whereas other metastases will be resected or treated by RFA. These groups of patients are:
- Patients with one to three (1-3) metachronous liver metastases of colorectal cancer, not larger than 5 cm, that are positioned in unresectable liver area, near blood vessels, but in otherwise operable patients.
Recurrent liver metastases of colorectal cancer, not more than 3 and not larger than 5 cm in diameter, each. For those patients any other treatment could represent unacceptable risk due to possibility of insufficient liver residual after resection or less effective radiofrequency ablation due to the proximity of blood vessels.
Groups 3 and 4 include patients with intent to cure within standard of care using two-stage surgical approach. This two-stage surgical approach will allow adding electrochemotherapy during the first operation and tissue collection for histological analysis during the second operation. Adding electrochemotherapy to these patients will not affect their treatment within standard of care recommended in the current guidelines. These groups of patients are:
- Patients with synchronous metastases, but their general condition and extent of the disease will not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor will be removed (colorectal resection) and some of the liver metastases will be treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non-treated metastases will be removed with liver resection.
- Patients with bilateral, multiple, metachronous metastases in whom standard treatment includ two-stage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein will be ligated and metastases on the left side will be excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non-treated metastases on the right side will be removed with right hemihepatectomy.
Electrochemotherapy will be offered to the patients also when they refuse standard treatment.
Depending on the position of metastases, appropriate electrodes will be selected; hexagonal needle electrodes with fixed geometry for metastases not larger than 3 cm in diameter, where their lower edge is located up to 3 cm below the liver capsule. ECT will be performed based on standard operating procedures for treatment of cutaneous and subcutaneous tumors / metastases with ECT.
Individual electrodes, positioned according to the prepared treatment plan will be used for metastases up to 5 cm in diameter, or located near vena cava or large hepatic or portal veins.
Electrochemotherapy will be performed within 8-28 min after intravenous in bolus administration of bleomycin (15 mg/m2).
Triggering of electric pulses will be synchronized with ECG signals, through the ECG triggering device AccuSync to avoid delivery of pulses in vulnerable period of the heart.
All patients will be treated after the procedure has been thoroughly described to them, and have signed informed consent.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Ljubljana, Slovenia, 1000
- Institute of Oncology Ljubljana
-
Ljubljana, Slovenia, 1000
- University Medical Centre Ljubljana, Ljubljana, Slovenia
-
Ljubljana, Slovenia, 1000
- Faculty of Electrical Engineering, University of Ljubljana, Slovenia
-
Maribor, Slovenia, 2000
- University Medical Centre Maribor, Maribor, Slovenia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Electrochemotherapy
|
Treatment procedure: anesthesia, positioning of electrodes, intravenous in bolus administration of bleomycin, within 8-30 min after administration of bleomycin application of electric pulses, removal of electrodes.
Positioning of electrodes, within 8-30 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 4 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization), removal of electrodes.
Intravenous in bolus administration of bleomycin (15 mg/m2), 8 minutes before application of electric pulses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of Safety Related to Electrochemotherapy
Time Frame: After operation on day 7
|
Recording of adverse events according to CTCAE criteria
|
After operation on day 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response to Treatment (Determined by Modified RECIST Criteria).
Time Frame: After operation on the days 30, 60, 90 and 120
|
Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI/CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
After operation on the days 30, 60, 90 and 120
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Gregor Sersa, PhD, Institute of Oncology Ljubljana, Ljubljana, Slovenia
- Principal Investigator: Ibrahim Edhemovic, MD, PhD, Institute of Oncology Ljubljana, Department of Surgical Oncology, Ljubljana, Slovenia
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-Z/KESOPKR-28
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Liver Metastases
-
Society of Interventional OncologyRecruitingColorectal Liver MetastasesUnited States, Netherlands, Greece
-
Memorial Sloan Kettering Cancer CenterCompletedLocalize Liver MetastasesUnited States
-
Heidelberg UniversityUnknownColorectal Liver MetastasesGermany
-
Dr. M.R. MeijerinkAmsterdam UMC, location VUmcCompletedColorectal Liver Metastases | Metastatic Liver DiseaseNetherlands
-
University of ZurichCompletedColorectal Liver MetastasesSwitzerland, France, Spain
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingUnresectable Colorectal Liver MetastasesFrance
-
Peking University Cancer Hospital & InstituteRecruitingColorectal Liver MetastasesChina
-
Amsterdam UMC, location VUmcCompletedColorectal Liver MetastasesNetherlands
-
David BartlettNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedColorectal Liver MetastasesUnited States
-
University of MilanCompleted
Clinical Trials on Electrochemotherapy
-
IGEATerminatedColorectal Adenocarcinoma
-
Uppsala University HospitalWithdrawnBreast Cancer | Skin MetastasesSweden
-
University Women's Hospital TübingenCompleted
-
Universita di VeronaIGEATerminatedPancreatic CancerItaly
-
Copenhagen University Hospital at HerlevWithdrawnUlcerated Cutaneous MetastasesDenmark
-
Institute of Oncology LjubljanaRecruiting
-
Copenhagen University Hospital at HerlevTerminated
-
European Institute of OncologyMerck Sharp & Dohme LLCRecruiting
-
Sophie HorbachIGEAUnknownVascular Malformations | Capillary MalformationsNetherlands
-
Rigshospitalet, DenmarkCopenhagen University Hospital at HerlevUnknown