Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT06677112
Status:
RECRUITING
Last Update Posted:
2025-11-13
First Post:
2024-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MCC-24-GYN-11: Comparison of Nodal Sampling in Endometrial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012018', 'term': 'Reflex'}], 'ancestors': [{'id': 'D009460', 'term': 'Neurologic Examination'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 625}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-11', 'studyFirstSubmitDate': '2024-11-04', 'studyFirstSubmitQcDate': '2024-11-04', 'lastUpdatePostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Location patterns of nodal involvement associated with staging procedures', 'timeFrame': '5 years'}, {'measure': 'Location patterns of nodal involvement associated with disease stage', 'timeFrame': '5 years'}, {'measure': 'Patterns of nodal involvement associated with histological characteristics', 'timeFrame': '5 years'}], 'primaryOutcomes': [{'measure': 'Recurrence free survival', 'timeFrame': 'up to 5 years', 'description': 'Participants with no measurable disease from study entry until disease recurrence, death, or date of the last contact'}], 'secondaryOutcomes': [{'measure': 'Concordance between selective surgical staging and final pathology Incidence', 'timeFrame': '5 years', 'description': 'Percentage of participants for whom selective surgical staging and final pathology match'}, {'measure': 'Progression-free survival', 'timeFrame': 'up to 5 years', 'description': 'period from study entry until disease progression, death, or date of the last contact'}, {'measure': 'Disease-specific Survival', 'timeFrame': 'up to 5 years', 'description': 'period from study entry until death from the disease (endometrial cancer)'}, {'measure': 'Overall patient survival rate', 'timeFrame': '5 years', 'description': 'period from study entry until death from any cause'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['selective surgical staging', 'lymphadenectomy'], '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. This study will gather information to help determine the best way to evaluate lymph nodes during surgery for endometrial cancer.'}, '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 carcinoma of the endometrium confined to the uterine corpus\n* No clinical evidence of extra-uterine disease on pre-operative evaluation. Preoperative evaluation to rule-out extra-uterine disease may include a CT scan, MRI or ultrasound. Note: preoperative imaging is not mandatory for study enrollment.\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\nNeoadjuvant chemotherapy for this endometrial cancer is not allowed.\n\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 Performance Status greater than 2 (Appendix II)\n* Uterine sarcoma\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 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 should be excluded\n* Known allergy to iodine or indocyanine 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. Women of child-bearing potential will be excluded if they have a positive serum/urine pregnancy test'}, 'identificationModule': {'nctId': 'NCT06677112', 'briefTitle': 'MCC-24-GYN-11: Comparison of Nodal Sampling in Endometrial Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Randomized Phase 3 Study of SELECTIVE SURGICAL STAGING Versus REFLEX Lymphadenectomy in Non-mappers Undergoing Sentinel Lymph Node Sampling for the Treatment of Endometrial Cancer', 'orgStudyIdInfo': {'id': '98450'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Selective Surgical Staging with side-specific lymphadenectomy (LAD)', 'description': 'Pathologist and surgeon jointly perform the Intraoperative Consultation (IOC).', 'interventionNames': ['Procedure: Selective surgical staging']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'REFLEX side-specific LAD', 'description': 'Sentinel node procedure', 'interventionNames': ['Procedure: REFLEX']}], 'interventions': [{'name': 'Selective surgical staging', 'type': 'PROCEDURE', 'description': 'Intraoperative Consultation, performed by pathologist and surgeon jointly. The uterus is inspected for extra-corpus spread (cervix, parametria, adnexa, distant). The surgical pathologist will evaluate the uterus according to the IOC Worksheet and promptly notify the surgeon of the results. The IOC will include evaluation for extra-corpus disease, lesion measurement, frozen section (to confirm measured lesion is malignant, cell type, and re-grading of tumor). Non-sentinel nodes will be handled according to institutional standard-of-care practice.', 'armGroupLabels': ['Selective Surgical Staging with side-specific lymphadenectomy (LAD)']}, {'name': 'REFLEX', 'type': 'PROCEDURE', 'description': 'The surgeon will perform a side-specific lymphadenectomy when there is no mapping on a hemipelvis (no tracer uptake in nodes). If neither side has successful Sentinel Node mapping, the surgeon performs a complete pelvic lymphadenectomy. Surgeons will remove the para-aortic lymph nodes at their discretion.', 'armGroupLabels': ['REFLEX side-specific LAD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40506', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rachel Miller, M.D.', 'role': 'CONTACT', 'email': 'raware00@uky.edu', 'phone': '859-323-2169'}], 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'centralContacts': [{'name': 'Rachel Miller', 'role': 'CONTACT', 'email': 'raware00@uky.edu', 'phone': '859-323-2169'}], 'overallOfficials': [{'name': 'Rachel Miller, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rachel Miller', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Rachel Miller', 'investigatorAffiliation': 'University of Kentucky'}}}}