Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2026-01-01 @ 1:52 PM
Study NCT ID:
NCT03142061
Status:
COMPLETED
Last Update Posted:
2024-07-22
First Post:
2017-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrochemotherapy for the Inoperable Vulva Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-19', 'studyFirstSubmitDate': '2017-05-03', 'studyFirstSubmitQcDate': '2017-05-03', 'lastUpdatePostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'local tumor control', 'timeFrame': 'Baseline', 'description': 'according to RECIST criteria'}, {'measure': 'Symptom control', 'timeFrame': 'Baseline', 'description': 'exulceration, secretion'}], 'secondaryOutcomes': [{'measure': 'Life quality', 'timeFrame': 'Baseline, 3, 6 months', 'description': 'EORTC QLQ'}, {'measure': 'Pain', 'timeFrame': 'Baseline, 3, 6 months', 'description': 'Visual scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Inoperable Vulva Carcinoma']}, 'descriptionModule': {'briefSummary': 'Electrochemotherapy (ECT) with Bleomycin in non-operable advanced vulva carcinoma', 'detailedDescription': 'Prospective evaluation of tumor response towards ECT by photo documentation. In addition prospective documentation of life quality after ECT treatment as well as evaluation of pain. .'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed consent\n* age ≥ 55 years (postmenopausal)\n* histologically proved cutan accessible vulva carcinoma\n* a maximum of 5 lesions ≥1 - ≤ 5 cm diameter; a maximum thickness of 3 cm\n* applied electrochemotherapy with electroporation\n\nExclusion Criteria:\n\n* Non compliant patients\n* Patients with symptomatic or rapidly progredient metastasis outside of the vulva'}, 'identificationModule': {'nctId': 'NCT03142061', 'briefTitle': 'Electrochemotherapy for the Inoperable Vulva Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Prospective Evaluation of Clinical Efficacy and Symptom Control Using Electrochemotherapy for the Inoperable Advanced Vulva Carcinoma', 'orgStudyIdInfo': {'id': '558/2015BO1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ECT', 'interventionNames': ['Procedure: Electrochemotherapy']}], 'interventions': [{'name': 'Electrochemotherapy', 'type': 'PROCEDURE', 'description': 'Bleomycin plus local electroporation of cutan accessible tumor tissue in patients with advanced inoperable vulva carcinoma', 'armGroupLabels': ['ECT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': "Department of Women's Health", 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}