Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT00712218
Status:
COMPLETED
Last Update Posted:
2020-03-04
First Post:
2008-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lymphadenectomy In Ovarian Neoplasms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal 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': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008197', 'term': 'Lymph Node Excision'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 640}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-03', 'studyFirstSubmitDate': '2008-07-03', 'studyFirstSubmitQcDate': '2008-07-08', 'lastUpdatePostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'time from randomization until death'}], 'secondaryOutcomes': [{'measure': '- Progression-free survival (PFS) - Quality of life (QoL) as measured by EORTC QLQ-C30, OV28 - number of resected lymph nodes', 'timeFrame': 'Progression-free survival time is calculated from the date of surgery until the date of first progressive disease or death, whichever occurs first or date of last contact (censored observation).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ovarian cancer, FIGO stage IIB-IV'], 'conditions': ['Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '30811909', 'type': 'DERIVED', 'citation': 'Harter P, Sehouli J, Lorusso D, Reuss A, Vergote I, Marth C, Kim JW, Raspagliesi F, Lampe B, Aletti G, Meier W, Cibula D, Mustea A, Mahner S, Runnebaum IB, Schmalfeldt B, Burges A, Kimmig R, Scambia G, Greggi S, Hilpert F, Hasenburg A, Hillemanns P, Giorda G, von Leffern I, Schade-Brittinger C, Wagner U, du Bois A. A Randomized Trial of Lymphadenectomy in Patients with Advanced Ovarian Neoplasms. N Engl J Med. 2019 Feb 28;380(9):822-832. doi: 10.1056/NEJMoa1808424.'}]}, 'descriptionModule': {'briefSummary': 'To assess the efficacy of systematic pelvic and para-aortic lymphadenectomy in patients with advanced ovarian cancer and intra-abdominal complete debulking.\n\nSecondary: progression-free survival, complications and quality of life; Exploratory: Role of number of resected lymph nodes for primary and secondary objectives'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary diagnosis of invasive epithelial ovarian cancer FIGO stage IIB-IV (IV only if resectable metastasis in pleura, liver, spleen, and/or abdominal wall)\n* Macroscopic complete resection\n* Age: 18 - 75 years\n* Patients who have given their signed and written informed consent\n* Good performance status (ECOG 0/1)\n\nExclusion Criteria:\n\n* Non epithelial ovarian malignancies and borderline tumors\n* Intraoperative clinically suspicious lymph nodes (bulky nodes)\n* Secondary invasive neoplasms in the last 5 years (except synchronal endometrial carcinoma FIGO IA G1/2, non melanoma skin cancer, breast cancer T1 N0 M0 G1/2) or with any signs of relapse or activity.\n* Recurrent ovarian cancer\n* Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy\n* Diseases of the lymph system (including lymph edema of unknown origin)\n* Clinical relevant dysfunctions of blood clotting (including medicamentous conditioned reasons, e.g. ASS, if not stopped at least 7 days prior to surgery)\n* Any significant medical reasons, age or performance status that will not allow to perform the study procedures (estimation of investigator)\n* Prior retroperitoneal lymph node dissection (systematic or sampling)\n* Pregnancy\n* Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent\n* Any reasons interfering with regular follow-up'}, 'identificationModule': {'nctId': 'NCT00712218', 'acronym': 'LION', 'briefTitle': 'Lymphadenectomy In Ovarian Neoplasms', 'organization': {'class': 'OTHER', 'fullName': 'Philipps University Marburg'}, 'officialTitle': 'Randomized, Multicentre Trial for Lymphadenectomy In Ovarian Neoplasms', 'orgStudyIdInfo': {'id': 'AGO-OVAR OP.3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'interventionNames': ['Procedure: No Lymphadenectomy (LNE)']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Procedure: Lymphadenectomy (LNE)']}], 'interventions': [{'name': 'No Lymphadenectomy (LNE)', 'type': 'PROCEDURE', 'description': 'No lymphadenectomy is performed in patients of the control group', 'armGroupLabels': ['A']}, {'name': 'Lymphadenectomy (LNE)', 'type': 'PROCEDURE', 'description': "Patients allocated to the lymphadenectomy group undergo systematic lymphadenectomy in addition to surgery for complete resection. Complete mobilization of the colon by resection of the paracolic gutters is necessary for the preparation of the lymphadenectomy. Afterwards the peritoneum has to be opened until the Treitzsche's Band for visualization of the renal vein. Systematic pelvic and para-aortic lymphadenectomy is based on anatomical studies and defined according to a recently published single centre series as systematic resection of lymph nodes in the following regions \\[24, \\].", 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Universitaetsklinik Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Universitaetskliniken LKH Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'AKH Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '4600', 'city': 'Wels', 'country': 'Austria', 'facility': 'Klinikum Wels-Grieskirchen', 'geoPoint': {'lat': 48.16667, 'lon': 14.03333}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '12808', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Odd G1, gyn. por. klinika VFN', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '73430', 'city': 'Aalen', 'country': 'Germany', 'facility': 'Ostalb Klinikum Aalen', 'geoPoint': {'lat': 48.83777, 'lon': 10.0933}}, {'zip': '91522', 'city': 'Ansbach', 'country': 'Germany', 'facility': 'Klinikum Ansbach', 'geoPoint': {'lat': 49.30481, 'lon': 10.5931}}, {'zip': '61348', 'city': 'Bad Homburg', 'country': 'Germany', 'facility': 'Hochtaunus-Kliniken gGmbH', 'geoPoint': {'lat': 50.22683, 'lon': 8.61816}}, {'zip': '10365', 'city': 'Berlin', 'country': 'Germany', 'facility': 'SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite Campus Virchow-Klinikum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '53105', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitaetsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '53123', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Malteser Krankenhaus Bonn-Rhein/Sieg', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '28177', 'city': 'Bremen', 'country': 'Germany', 'facility': 'Klinikum Bremen', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'zip': '50931', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Universitaetsklinik Koeln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '94469', 'city': 'Deggendorf', 'country': 'Germany', 'facility': 'Klinikum des Landkreises Deggendorf', 'geoPoint': {'lat': 48.84085, 'lon': 12.96068}}, {'zip': '86609', 'city': 'Donauwörth', 'country': 'Germany', 'facility': 'Donau-Ries Klinik Donauwoerth', 'geoPoint': {'lat': 48.71804, 'lon': 10.7793}}, {'zip': '01304', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitaetsklinikum Carl Gustac Carus', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '40217', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Evangelisches Krankenhaus', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '40489', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Kaiserswerther Diakonie, Florence-Nightingale Krankenhaus', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Universitaetsklinikum Erlangen-Nuernberg', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '45122', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universitaetsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '45136', 'city': 'Essen', 'country': 'Germany', 'facility': 'Kliniken Essen Mitte - Evang. 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