RecruitingPhase 3NCT03772028

Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Phase III Randomized Clinical Trial for Stage III Epithelial Ovarian Cancer Randomizing Between Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy


Sponsor

The Netherlands Cancer Institute

Enrollment

538 participants

Start Date

Jan 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria2

  • candidate for primary CRS
  • histological or cytological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer

Exclusion Criteria4

  • history of previous malignancies within 5 years prior to inclusion
  • FIGO stage IV disease
  • complete primary cytoreduction is impossible
  • prior treatment for the current malignancy

Interventions

DRUGcisplatin

HIPEC with cisplatin after cytoreductive surgery


Locations(28)

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

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NCT03772028


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