Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-04-23 @ 7:03 AM
Study NCT ID:
NCT02352259
Status:
COMPLETED
Last Update Posted:
2021-03-24
First Post:
2014-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D053672', 'term': 'Electrochemotherapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000092722', 'term': 'Electroporation Therapies'}, {'id': 'D018274', 'term': 'Electroporation'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055664', 'term': 'Electrochemical Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gsersa@onko-i.si', 'phone': '+38615874343', 'title': 'Dr Gregor Serša', 'organization': 'Institute of Oncology Ljubljana'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '7, 30, 60, 90, 120 days', 'description': 'adverse events observed in 3 out of 23 patients, no serious adverse events', 'eventGroups': [{'id': 'EG000', 'title': 'Electrochemotherapy', 'description': 'All patients were administered with intravenous bolus of bleomycin (15,000 IU/m2, Bleomycin medac, Medac, Hamburg, Germany), after intraoperative ultrasound confirmed the correct electrode placement. Eight minutes after bleomycin injection, electric pulses were delivered by Cliniporator®VITAE (IGEA SpA, Carpi, Italy).', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 3, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'SIRS', 'notes': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'arrhythmia', 'notes': 'arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Evaluation of Safety Related to Electrochemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrochemotherapy', 'description': 'All patients were administered with intravenous bolus of bleomycin (15,000 IU/m2, Bleomycin medac, Medac, Hamburg, Germany), after intraoperative ultrasound confirmed the correct electrode placement. Eight minutes after bleomycin injection, electric pulses were delivered by Cliniporator®VITAE (IGEA SpA, Carpi, Italy).'}], 'classes': [{'categories': [{'title': 'No adverse events', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'ECT nonrelated mild adverse avents', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'ECT related mild adverse avents', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Adverse avents', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After operation on day 7', 'description': 'Recording of adverse events according to CTCAE criteria', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Response to Treatment (Determined by Modified RECIST Criteria).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrochemotherapy', 'description': 'All patients were administered with intravenous bolus of bleomycin (15,000 IU/m2, Bleomycin medac, Medac, Hamburg, Germany), after intraoperative ultrasound confirmed the correct electrode placement. Eight minutes after bleomycin injection, electric pulses were delivered by Cliniporator®VITAE (IGEA SpA, Carpi, Italy).'}], 'classes': [{'categories': [{'title': 'complete response (CR)', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'partial response (PR)', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'progressive disease (PD)', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After operation on the days 30, 60, 90 and 120', 'description': 'Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI/CT:\n\nComplete 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', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Electrochemotherapy', 'description': 'All patients were administered with intravenous bolus of bleomycin (15,000 IU/m2, Bleomycin medac, Medac, Hamburg, Germany), after intraoperative ultrasound confirmed the correct electrode placement. Eight minutes after bleomycin injection, electric pulses were delivered by Cliniporator®VITAE (IGEA SpA, Carpi, Italy).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Electrochemotherapy', 'description': 'All patients were administered with intravenous bolus of bleomycin (15,000 IU/m2, Bleomycin medac, Medac, Hamburg, Germany), after intraoperative ultrasound confirmed the correct electrode placement. Eight minutes after bleomycin injection, electric pulses were delivered by Cliniporator®VITAE (IGEA SpA, Carpi, Italy).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Slovenia', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'CRC liver metastases', 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Patients presented with CRC liver metastases', 'unitOfMeasure': 'metastases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-03-30', 'size': 414529, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-03-01T08:30', 'hasProtocol': False}, {'date': '2013-03-30', 'size': 732558, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-01T08:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-01', 'studyFirstSubmitDate': '2014-12-17', 'resultsFirstSubmitDate': '2020-11-12', 'studyFirstSubmitQcDate': '2015-01-27', 'lastUpdatePostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-01', 'studyFirstPostDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Safety Related to Electrochemotherapy', 'timeFrame': 'After operation on day 7', 'description': 'Recording of adverse events according to CTCAE criteria'}], 'secondaryOutcomes': [{'measure': 'Response to Treatment (Determined by Modified RECIST Criteria).', 'timeFrame': 'After operation on the days 30, 60, 90 and 120', 'description': 'Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI/CT:\n\nComplete 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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Liver metastases of colorectal cancer Electrochemotherapy', 'Bleomycin', 'Electrochemotherapy'], 'conditions': ['Liver Metastases']}, 'referencesModule': {'references': [{'pmid': '24782355', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21895032', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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:\n\n1. 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.\n2. 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.\n\n 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:\n3. 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.\n4. 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.\n\nElectrochemotherapy will be offered to the patients also when they refuse standard treatment.\n\nDepending 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.\n\nIndividual 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.\n\nElectrochemotherapy will be performed within 8-28 min after intravenous in bolus administration of bleomycin (15 mg/m2).\n\nTriggering 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.\n\nAll patients will be treated after the procedure has been thoroughly described to them, and have signed informed consent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically and/or cytologically confirmed colorectal cancer.\n2. Age over 18.\n3. Life expectancy more than 3 month.\n4. Performance status Karnofsky ≥ 70 or (World Health Organization) WHO ≤ 2.\n5. Chemotherapy free interval 2-5 weeks, depending on the drugs used.\n6. Patient must be mentally capable of understanding the information given.\n7. Patient must give informed consent.\n8. Patient must be discussed at the multidisciplinary team for tumors of the gastrointestinal tract before entering the trial.\n\nExclusion Criteria:\n\n1. Secondary primary tumor, except surgically treated noninvasive cancer of cervix, or surgically or irradiated basal cell carcinoma\n2. Visceral, bone or diffuse metastases.\n3. Life-threatening infection and/or heart failure and/or liver failure and/or other severe systemic pathologies.\n4. Clinically significant ascites.\n5. Significant reduction in respiratory function.\n6. Age less than 18 years.\n7. Coagulation disturbances.\n8. Cumulative dose of 250 mg/m2 bleomycin received.\n9. Allergic reaction to bleomycin.\n10. Impaired kidney function (creatinin \\> 150 µmol/l).\n11. Patients with epilepsy.\n12. Patients with arrhythmias.\n13. Patients with pacemaker or defibrillator.\n14. Pregnancy.\n15. Patient incapable of understanding the aim of the study or disagree with the entering into the clinical study.'}, 'identificationModule': {'nctId': 'NCT02352259', 'briefTitle': 'Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Oncology Ljubljana'}, 'officialTitle': 'Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II', 'orgStudyIdInfo': {'id': '03-Z/KESOPKR-28'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electrochemotherapy', 'interventionNames': ['Procedure: Electrochemotherapy', 'Device: Cliniporator Vitae®', 'Drug: Bleomycin PHC 15 e. (United States Pharmacopeia - USP)']}], 'interventions': [{'name': 'Electrochemotherapy', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Electrochemotherapy']}, {'name': 'Cliniporator Vitae®', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Electrochemotherapy']}, {'name': 'Bleomycin PHC 15 e. (United States Pharmacopeia - USP)', 'type': 'DRUG', 'description': 'Intravenous in bolus administration of bleomycin (15 mg/m2), 8 minutes before application of electric pulses', 'armGroupLabels': ['Electrochemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Faculty of Electrical Engineering, University of Ljubljana, Slovenia', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}, {'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Institute of Oncology Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}, {'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'University Medical Centre Ljubljana, Ljubljana, Slovenia', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}, {'zip': '2000', 'city': 'Maribor', 'country': 'Slovenia', 'facility': 'University Medical Centre Maribor, Maribor, Slovenia', 'geoPoint': {'lat': 46.55583, 'lon': 15.64593}}], 'overallOfficials': [{'name': 'Gregor Sersa, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institute of Oncology Ljubljana, Ljubljana, Slovenia'}, {'name': 'Ibrahim Edhemovic, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Oncology Ljubljana, Department of Surgical Oncology, Ljubljana, Slovenia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Oncology Ljubljana', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, {'name': 'University Medical Centre Maribor', 'class': 'OTHER'}, {'name': 'University of Ljubljana', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}