Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2026-03-05 @ 5:42 AM
Study NCT ID:
NCT03772028
Status:
RECRUITING
Last Update Posted:
2023-09-08
First Post:
2018-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
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': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled, open-label, multicenter phase III trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 538}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-07', 'studyFirstSubmitDate': '2018-09-21', 'studyFirstSubmitQcDate': '2018-12-10', 'lastUpdatePostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '1 year after last patient last visit'}], 'secondaryOutcomes': [{'measure': 'recurrence-free survival', 'timeFrame': '1 year after last patient last visit'}, {'measure': 'adverse events', 'timeFrame': '30 days after end of treatment', 'description': 'toxicity of extra treatment compared standaard treatment'}, {'measure': 'cost evaluation', 'timeFrame': '1 year after lplv', 'description': 'cost evaluation based measured by quality adjusted life year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ovarian cancer', 'HIPEC', 'OVHIPEC', 'primary debulking'], 'conditions': ['Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '32205449', 'type': 'DERIVED', 'citation': 'Koole S, van Stein R, Sikorska K, Barton D, Perrin L, Brennan D, Zivanovic O, Mosgaard BJ, Fagotti A, Colombo PE, Sonke G, Driel WJV; OVHIPEC-2 Steering Committee and the Dutch OVHIPEC group. Primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) for FIGO stage III epithelial ovarian cancer: OVHIPEC-2, a phase III randomized clinical trial. Int J Gynecol Cancer. 2020 Jun;30(6):888-892. doi: 10.1136/ijgc-2020-001231. Epub 2020 Mar 23.'}]}, 'descriptionModule': {'briefSummary': 'stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy', 'detailedDescription': 'The objective of this study is to prove that treatment with primary cytoreductive surgery in combination with HIPEC (treatment arm) improves outcome compared to primary cytoreductive surgery without HIPEC (standard arm) with acceptable morbidity, in patients with FIGO stage III epithelial ovarian cancer who are eligible for primary cytoreductive surgery with no residual disease, or residual disease up to 2.5 mm.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'ovarian cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* candidate for primary CRS\n* histological or cytological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer\n\nExclusion Criteria:\n\n* history of previous malignancies within 5 years prior to inclusion\n* FIGO stage IV disease\n* complete primary cytoreduction is impossible\n* prior treatment for the current malignancy'}, 'identificationModule': {'nctId': 'NCT03772028', 'acronym': 'OVHIPEC-2', 'briefTitle': 'Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)', 'organization': {'class': 'OTHER', 'fullName': 'The Netherlands Cancer Institute'}, 'officialTitle': 'Phase III Randomized Clinical Trial for Stage III Epithelial Ovarian Cancer Randomizing Between Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy', 'orgStudyIdInfo': {'id': 'M17OVH'}, 'secondaryIdInfos': [{'id': 'ENGOT-ov52/DGOG/OVHIPEC-2', 'type': 'OTHER', 'domain': 'European Network of Gynaecological Oncological trials Groups'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'conventional surgery', 'description': 'Primary cytoreductive surgery without HIPEC'}, {'type': 'EXPERIMENTAL', 'label': 'HIPEC', 'description': 'Primary cytoreductive surgery with HIPEC with cisplatin', 'interventionNames': ['Drug: cisplatin']}], 'interventions': [{'name': 'cisplatin', 'type': 'DRUG', 'description': 'HIPEC with cisplatin after cytoreductive surgery', 'armGroupLabels': ['HIPEC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Thanh Dellinger, MD', 'role': 'CONTACT', 'phone': '626-256-4673', 'phoneExt': '95200'}], 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bhavani Ramesh', 'role': 'CONTACT', 'email': 'rameshb@mskcc.org'}, {'name': 'Oliver Zivanovic', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MSKCC New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Alice Bjoernlund-Larsen', 'role': 'CONTACT', 'email': 'alice.bjoernlund-larsen@regionh.dk'}, {'name': 'Berit Jul Mosgaard', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rigshospitalet Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nabila Bouazza', 'role': 'CONTACT', 'email': 'Nabila.Bouazza@icm.unicancer.fr'}, {'name': 'Laura Mansi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Besancon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nabila Bouazza', 'role': 'CONTACT', 'email': 'Nabila.Bouazza@icm.unicancer.fr'}, {'name': 'F. Guyon', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nabila Bouazza', 'role': 'CONTACT', 'email': 'Nabila.Bouazza@icm.unicancer.fr'}, {'name': 'Frederic Guyon, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'o Institut Bergonié, Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nabila Bouazza', 'role': 'CONTACT', 'email': 'Nabila.Bouazza@icm.unicancer.fr'}, {'name': 'Clarisse Eveno', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nabila B Bouazza', 'role': 'CONTACT', 'email': 'Nabila.Bouazza@icm.unicancer.fr'}, {'name': 'Pierre Meeus, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Leon Berard, Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nabila B Bouazza', 'role': 'CONTACT', 'email': 'Nabila.Bouazza@icm.unicancer.fr'}, {'name': 'Naoual Bakrin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nabila Bouazza', 'role': 'CONTACT', 'email': 'Nabila.Bouazza@icm.unicancer.fr'}, {'name': 'Pierre-Emmanuel Colombo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut du Cancer Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nabila Bouazza', 'role': 'CONTACT', 'email': 'Nabila.Bouazza@icm.unicancer.fr'}, {'name': 'Charlotte Bourgin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Institut de Cancerologie de l'Ouest, ICO Nantes)", 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nabila Bouazza', 'role': 'CONTACT', 'email': 'Nabila.Bouazza@icm.unicancer.fr'}, {'name': 'Jean Guillaume FERON', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Curie Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nabila Bouazza', 'role': 'CONTACT', 'email': 'Nabila.Bouazza@icm.unicancer.fr'}, {'name': 'Cherif Akladios', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHRU Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nabila Bouazza', 'role': 'CONTACT', 'email': 'Nabila.Bouazza@icm.unicancer.fr'}, {'name': 'Ferron Gwenael', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oncopole, Institute Universitaire du Cancer de Toulouse (IUCT Toulouse)', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Dublin', 'status': 'RECRUITING', 'country': 'Ireland', 'contacts': [{'name': 'Terri Martin', 'role': 'CONTACT', 'email': 'tmartin@mater.ie'}, {'name': 'Donal Brennan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mater Misericordiae University Hospital, Dublin', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pierandrea De Iaco', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Policlinico Sant'Orsola, Bologna", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Deamicis', 'role': 'CONTACT', 'email': 'andrea.deamicis@policlinicogemelli.it'}, {'name': 'Anna Fagotti', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione Policlinico A Gemelli IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '1066CX', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Lot Aronson, PhD student', 'role': 'CONTACT', 'email': 'l.aronson@nki.nl'}, {'name': 'Ruby van Stein, PhD student', 'role': 'CONTACT', 'email': 'r.v.stein@nki.nl'}, {'name': 'Willemien van Driel, dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Antoni van leeuwenhoek', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Eindhoven', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Catharina Hospital', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Enschede', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Medisch Spectrum Twente', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'city': 'Groningen', 'status': 'RECRUITING', 'country': 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Schreuder, MD', 'role': 'CONTACT', 'email': 'H.W.R.Schreuder@umcutrecht.nl'}], 'facility': 'UMCU', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Uppsala', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Alice Bjoernlund-Larsen', 'role': 'CONTACT', 'email': 'alice.bjoernlund-larsen@regionh.dk'}, {'name': 'Marta Lomnytska', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Alice Bjoernlund-Larsen', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'centralContacts': [{'name': 'Willemien van Driel, MD, PhD', 'role': 'CONTACT', 'email': 'OVHIPEC@nki.nl', 'phone': '031 20 512 7918'}, {'name': 'Lot Aronson', 'role': 'CONTACT', 'email': 'OVHIPEC@nki.nl', 'phone': '031 20 512 7918'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Netherlands Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}