Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
Study NCT ID:
NCT02091050
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2014-03-13
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
2D vs 3D Planning for High-Dose Rate (HDR) Gynecological Brachytherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-29', 'studyFirstSubmitDate': '2014-03-13', 'studyFirstSubmitQcDate': '2014-03-17', 'lastUpdatePostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dosimetry of Organs of genitourinary and gastrointestinal tracts', 'timeFrame': 'one week after the tomograph', 'description': 'Dose in bladder; rectum; small intestine; sigmoid colon; urethra; dose trigone; vaginal cuff.'}], 'secondaryOutcomes': [{'measure': 'Cost analysis with local care.', 'timeFrame': '6 weeks'}, {'measure': 'Acute Genitourinary Toxicity', 'timeFrame': '6 weeks', 'description': 'toxicity associated with the genitourinary tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)'}, {'measure': 'Acute Gastrointestinal toxicity', 'timeFrame': '6 weeks', 'description': 'toxicity associated with the gastrointestinal tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)'}, {'measure': 'Late Genitourinary Toxicity', 'timeFrame': '3 Years', 'description': 'toxicity associated with the genitourinary tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)'}, {'measure': 'Late Gastrointestinal toxicity', 'timeFrame': '3 Years', 'description': 'toxicity associated with the gastrointestinal tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['3D Brachytherapy', 'cervical cancer', 'endometrial cancer', 'vaginal vault brachytherapy'], 'conditions': ['Cervix Cancer', 'Endometrial Cancer']}, 'referencesModule': {'references': [{'pmid': '27296459', 'type': 'RESULT', 'citation': 'Sapienza LG, Flosi A, Aiza A, de Assis Pellizzon AC, Chojniak R, Baiocchi G. Volumetric (3D) bladder dose parameters are more reproducible than point (2D) dose parameters in vaginal vault high-dose-rate brachytherapy. Sci Rep. 2016 Jun 14;6:28074. doi: 10.1038/srep28074.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/27296459', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Demonstrate the limitations of conventional dosimetry (2D) for the adjuvant brachytherapy treatment and assess whether tridimensional dosimetry relates more faithfully with the occurrence of adverse effects.', 'detailedDescription': 'Radiotherapy is part of a multidisciplinary strategy to fight cancer in all stages, using ionizing radiation to cause damage in tumor cells. After radical surgical treatment of gynecological tumors, pathological findings, such as extension of the myometrium invasion, histologic grade, and vascular- lymphatic invasion predict the risk of locoregional recurrence of disease and, consequently, the need for adjuvant treatment. There are two main methods of adjuvant therapy after hysterectomy for malignant neoplasm of the cervix or endometrium: external beam radiotherapy with or without booster dose of vaginal vault brachytherapy or brachytherapy alone. There are few data in the literature and clinical experience with brachytherapy dimensional (3D) for adjuvant treatment of vaginal vault .\n\nObjective: To demonstrate the limitations of conventional dosimetry (2D) for the adjuvant brachytherapy treatment and assess whether tridimensional dosimetry relates more faithfully with the occurrence of adverse effect.\n\nMethods: A prospective study in the Department of Radiation Oncology, Antonio Candido Camargo Cancer Center will be developed with an expected duration of 14 months and will include 60 patients. Dosimetric parameters of brachytherapy treatment of vaginal vault, able to influence the incidence of adverse effects will be evaluated. Computed tomography for planning of external beam radiotherapy and brachytherapy planning will be used, after placement of intra- vaginal applicator and urinary catheter. For planning brachytherapy two fast acquisition sequences, one with a urinary catheter not pulled and pulled another with the probe will be obtained. The prescription dose obey the standard indication of document of the International Commission on Radiation Units \\& Measurements (ICRU 38).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Malignant neoplasm of the cervix or endometrium;\n* Tomography scan available in the planning system.\n\nExclusion Criteria:\n\n* Patients did not undergo surgery as initial treatment;\n* Patients without available tomography for planning;'}, 'identificationModule': {'nctId': 'NCT02091050', 'briefTitle': '2D vs 3D Planning for High-Dose Rate (HDR) Gynecological Brachytherapy', 'organization': {'class': 'OTHER', 'fullName': 'AC Camargo Cancer Center'}, 'officialTitle': 'Clinical and Dosimetric Comparison of 2D Versus 3D HDR Brachytherapy', 'orgStudyIdInfo': {'id': 'AC-G 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'HDR Brachytherapy 24Gy (4 x 6Gy)', 'description': 'Vaginal vault brachytherapy, associated or not with external beam radiotherapy.', 'interventionNames': ['Other: 2D HDR planning', 'Other: 3D HDR planning']}], 'interventions': [{'name': '2D HDR planning', 'type': 'OTHER', 'description': 'HDR planning using simple radiograph (2D)', 'armGroupLabels': ['HDR Brachytherapy 24Gy (4 x 6Gy)']}, {'name': '3D HDR planning', 'type': 'OTHER', 'description': 'HDR planning using computed tomography (3D)', 'armGroupLabels': ['HDR Brachytherapy 24Gy (4 x 6Gy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01509 - 010', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'AC Camargo Cancer Center', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AC Camargo Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Lucas Gomes Sapienza', 'investigatorAffiliation': 'AC Camargo Cancer Center'}}}}