Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-04 @ 5:15 AM
Study NCT ID:
NCT04970368
Status:
TERMINATED
Last Update Posted:
2024-01-05
First Post:
2021-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Nodal Staging in Endometrial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D009369', 'term': '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': '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'whyStopped': 'Slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-03', 'studyFirstSubmitDate': '2021-06-25', 'studyFirstSubmitQcDate': '2021-07-09', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Location patterns of nodal involvement associated with staging procedures', 'timeFrame': '5 years', 'description': 'Location patterns related to nodal involvement with staging procedures will be reported.'}, {'measure': 'Number of metastatic lymph node(s) associated with staging procedures', 'timeFrame': '5 years', 'description': 'The number of metastatic lymph node(s) associated with the staging procedures will be reported.'}, {'measure': 'Patterns of nodal involvement associated with primary tumor grade', 'timeFrame': '5 years', 'description': 'Primary tumor grade related to nodal involvement will be reported'}, {'measure': 'Patterns of nodal involvement associated with primary tumor lesion size', 'timeFrame': '5 years', 'description': 'Primary tumor lesion size related to nodal involvement will be reported.'}, {'measure': 'Patterns of nodal involvement associated with primary tumor depth of invasion', 'timeFrame': '5 years', 'description': 'Primary tumor depth related to nodal involvement will be reported.'}, {'measure': 'Patterns of nodal involvement associated with primary tumor cell type', 'timeFrame': '5 years', 'description': 'Primary tumor cell type related to nodal involvement will be reported.'}, {'measure': 'Location patterns of nodal involvement associated with disease stage', 'timeFrame': '5 years', 'description': 'Location related to nodal involvement with disease stage will be reported.'}, {'measure': 'Number of metastatic lymph node(s) associated with disease stage', 'timeFrame': '5 years', 'description': 'The number of metastatic lymph node(s) associated with the staging procedures will be reported.'}], 'primaryOutcomes': [{'measure': 'Recurrence-free survival rate', 'timeFrame': '5 years', 'description': 'Recurrence-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival rate', 'timeFrame': '5 years', 'description': 'Progress-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging'}, {'measure': 'Disease-specific survival rate', 'timeFrame': '5 years', 'description': 'Disease-specific survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging'}, {'measure': 'Overall patient survival rate', 'timeFrame': '5 years', 'description': 'Overall survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging'}, {'measure': 'Concordance of SELECTIVE and SENTINEL NODE surgical staging with final pathology', 'timeFrame': '5 years', 'description': 'Percentage of participants for whom selective surgical staging and final pathology match. Match incorporates grade, lesion size, depth of invasion, and low-risk (no lymphadenectomy) versus high-risk (lymphadenectomy).'}, {'measure': 'Patient morbidity', 'timeFrame': '5 years'}, {'measure': 'Patient mortality', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sentinel node', 'Cancer', 'Endometrial', 'Intraoperative Consultation'], 'conditions': ['Endometrial Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to estimate the recurrence-free survival rates in women with endometrial cancer treated with selective versus sentinel node surgical staging.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgical candidate for complete hysterectomy and bilateral salpingooophorectomy with pelvic and aortic lymphadenectomy\n* Histologically or cytologically confirmed endometrioid-type endometrial cancer confined to the uterine corpus\n* No clinical evidence of extra-uterine disease on pre-operative evaluation.\n* Prior systemic chemotherapy is allowed so long as it was at least five years prior to study enrollment, and there is no evidence of disease after such therapy.\n* Age ≥18 years.\n* Life expectancy (estimated survival) of at least 6 months.\n* AST(SGOT)/ALT(SGPT) \\< 3.0X upper limit of normal\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* GOG/ECOG Performance Status greater than 2\n* Non-endometrioid cell type\n* Clinical evidence of disease that extends beyond the uterus, including the presence of suspicious aortic or inguinal nodes on imaging or clinical exam\n* Previous vaginal, pelvic or abdominal irradiation\n* Chemotherapy, hormone therapy or immunotherapy directed at the present disease\n* Previous pelvic lymphadenectomy or retroperitoneal surgery\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Known allergy to iodine or indigocyanine green (ICG) tracer, or allergic reactions to compounds of similar chemical or biologic composition\n* Patients with uncontrolled intercurrent illness\n* Patients with psychiatric illness/social situations that would limit compliance with study requirements\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT04970368', 'briefTitle': 'Comparison of Nodal Staging in Endometrial Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Randomized Phase 3 Study of Selective Versus Sentinel Node Surgical Staging for the Treatment of Endometrial Cancer', 'orgStudyIdInfo': {'id': 'MCC-21-GYN-210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sentinel Node Surgical Staging', 'interventionNames': ['Procedure: Sentinel node procedure']}, {'type': 'EXPERIMENTAL', 'label': 'Selective Surgical Staging', 'interventionNames': ['Procedure: Selective staging']}], 'interventions': [{'name': 'Sentinel node procedure', 'type': 'PROCEDURE', 'description': 'Excision of ALL mapped nodes and other suspicious nodes regardless of mapping and label by anatomic location', 'armGroupLabels': ['Sentinel Node Surgical Staging']}, {'name': 'Selective staging', 'type': 'PROCEDURE', 'description': 'Intraoperative consultation (IOC)', 'armGroupLabels': ['Selective Surgical Staging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40506', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Frederick Ueland, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Frederick R. Ueland, M.D.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Frederick R. Ueland, M.D.', 'investigatorAffiliation': 'University of Kentucky'}}}}