Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
NCT ID: NCT03772028
Last Updated: 2023-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
538 participants
INTERVENTIONAL
2020-01-01
2026-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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conventional surgery
Primary cytoreductive surgery without HIPEC
No interventions assigned to this group
HIPEC
Primary cytoreductive surgery with HIPEC with cisplatin
cisplatin
HIPEC with cisplatin after cytoreductive surgery
Interventions
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cisplatin
HIPEC with cisplatin after cytoreductive surgery
Eligibility Criteria
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Inclusion Criteria
* histological or cytological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer
Exclusion Criteria
* FIGO stage IV disease
* complete primary cytoreduction is impossible
* prior treatment for the current malignancy
18 Years
FEMALE
No
Sponsors
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The Netherlands Cancer Institute
OTHER
Responsible Party
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Locations
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City of Hope
Duarte, California, United States
MSKCC New York
New York, New York, United States
Rigshospitalet Copenhagen
Copenhagen, , Denmark
CHU de Besancon
Besançon, , France
Institut Bergonié
Bordeaux, , France
o Institut Bergonié, Bordeaux
Bordeaux, , France
CHU Lille
Lille, , France
Centre Leon Berard, Lyon
Lyon, , France
CHU Lyon
Lyon, , France
Institut du Cancer Montpellier
Montpellier, , France
Institut de Cancerologie de l'Ouest, ICO Nantes)
Nantes, , France
Institut Curie Paris
Paris, , France
CHRU Strasbourg
Strasbourg, , France
Oncopole, Institute Universitaire du Cancer de Toulouse (IUCT Toulouse)
Toulouse, , France
Mater Misericordiae University Hospital, Dublin
Dublin, , Ireland
Policlinico Sant'Orsola, Bologna
Bologna, , Italy
Fondazione Policlinico A Gemelli IRCCS
Roma, , Italy
Antoni van leeuwenhoek
Amsterdam, North Holland, Netherlands
Amsterdam UMC
Amsterdam, , Netherlands
Catharina Hospital
Eindhoven, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
UMCG
Groningen, , Netherlands
Leiden University Medical Center (LUMC)
Leiden, , Netherlands
Maastricht UMC+
Maastricht, , Netherlands
Radboud MC
Nijmegen, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
UMCU
Utrecht, , Netherlands
Alice Bjoernlund-Larsen
Uppsala, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Thanh Dellinger, MD
Role: primary
References
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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.
Other Identifiers
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ENGOT-ov52/DGOG/OVHIPEC-2
Identifier Type: OTHER
Identifier Source: secondary_id
M17OVH
Identifier Type: -
Identifier Source: org_study_id
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