Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-01 @ 9:15 AM
Study NCT ID:
NCT03466957
Status:
UNKNOWN
Last Update Posted:
2018-03-15
First Post:
2018-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individual Approach in Gynecological Cancer Brachytherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 13}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-14', 'studyFirstSubmitDate': '2018-03-01', 'studyFirstSubmitQcDate': '2018-03-14', 'lastUpdatePostDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'target volume CTV-HR', 'timeFrame': 'at two hours after the end of brachytherapy procedure', 'description': 'V100 (%), D90 (%), D98 (%), D100 (%)'}], 'secondaryOutcomes': [{'measure': 'organs at risk', 'timeFrame': 'at two hours after the end of brachytherapy procedure', 'description': 'D2cc (Gy), D0.1cc (Gy), Dmax (Gy)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['image guided brachytherapy', '3D print', 'gynecological cancer'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': "MRI guided adaptive brachytherapy (BT) represents the gold standard in the treatment of gynecological cancers. Commercially available standard MRI compatible applicators for BT of gynecological cancers don't always allow for optimal target volume coverage. Three-dimensional (3D) printed technology enables versatile possibilities of improvement of standard applicators and development of novel applicators with better coverage of the target volume. The purpose of this study is to implement and assess 3D printing technology as an instrument for designing and manufacturing applicators for individualized BT of gynecological cancers.", 'detailedDescription': 'Patients with locoregionally gynecological cancers will be included in this single-institution, non-randomized, one-arm study. All patients will receive 45-50 Gy external beam radiotherapy (EBRT) with intensity-modulated radiotherapy/volumetric-modulated arc therapy (IMRT/VMAT) technique, 1.8-2 Gy/fraction +/- concurrent cisplatin based chemotherapy. First BT with commercially available standard applicators (tandem with ring +/- parallel needles or vaginal cylinder) will be carried out. MRI with applicator in situ will be performed, high-risk clinical target volume (CTV-HR) and organs at risk (OAR) will be delineated and treatment planning will be conducted. In the case of large gynecological cancer and suboptimal target coverage at BT (V100 ≤ 90%, D98 ≤ 80%, D90 ≤ 100%, D100 ≤ 60%) a preplan will be performed as the basis for the 3D applicator modelling. The next BT application will be performed with an individually designed 3D printed applicator. Dose-volume characteristics of the following treatment plans will be compared: the preplan, the plan with standard and the plan with individual 3D printed applicator.\n\nThe primary objective of the study is to determine the improvement of dose-volume parameters with the use of 3D printed individual applicators in advanced gynecological cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with locally advanced gynecological cancer (cervical, uterine, vaginal, vulvar cancer) eligible for treatment with brachytherapy\n* squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma, histologically proven\n* patients fit for regional or general anesthesia\n* signed written informed consent\n\nExclusion Criteria:\n\n* regional or general anesthesia contraindications\n* contraindications for MRI'}, 'identificationModule': {'nctId': 'NCT03466957', 'briefTitle': 'Individual Approach in Gynecological Cancer Brachytherapy', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Oncology Ljubljana'}, 'officialTitle': 'Development and Assessment of Individual 3D Printed Applicators in MRI Guided Gynecological Brachytherapy', 'orgStudyIdInfo': {'id': 'ERID-KESOPKR/63'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3D printed applicator', 'description': 'individually designed applicator for BT', 'interventionNames': ['Other: 3D printed applicator']}], 'interventions': [{'name': '3D printed applicator', 'type': 'OTHER', 'otherNames': ['individual applicator'], 'description': 'add-on cap for oblique needles, 3D printed Vienna-like applicator, individual vaginal cylinder for intracavitary/interstitial application', 'armGroupLabels': ['3D printed applicator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Violeta Kaluza', 'role': 'CONTACT', 'email': 'vkaluza@onko-i.si', 'phone': '0038115879122'}, {'name': 'Helena Barbara Zobec Logar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Barbara Šegedin, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Robert Hudej, physicist', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Manja Šešek, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Institute of Oncology Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'centralContacts': [{'name': 'Helena Barbara Zobec Logar, MD', 'role': 'CONTACT', 'email': 'hlogar@onko-i.si', 'phone': '0038615879204'}], 'overallOfficials': [{'name': 'Helena Barbara Zobec Logar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brachytherapy Department, Institute of Oncology Ljubljana, Slovenia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Oncology Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}