Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (OVHIPEC-2)

April 2, 2026 updated by: The Netherlands Cancer Institute

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

538

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet Copenhagen
  • France
      • Besançon, France
        • CHU de Besançon
      • Bordeaux, France
        • Institut Bergonie
      • Bordeaux, France
        • o Institut Bergonié, Bordeaux
      • Lille, France
        • CHU Lille
      • Lyon, France
        • CHU Lyon
      • Lyon, France
        • Centre Leon Berard, Lyon
      • Montpellier, France
        • Institut Du Cancer Montpellier
      • Nantes, France
        • Institut de Cancerologie de l'Ouest, ICO Nantes)
      • Paris, France
        • Institut Curie Paris
      • Strasbourg, France
        • CHRU Strasbourg
      • Toulouse, France
        • Oncopole, Institute Universitaire du Cancer de Toulouse (IUCT Toulouse)
  • Ireland
      • Dublin, Ireland
        • Mater Misericordiae University Hospital, Dublin
  • Italy
      • Bologna, Italy
        • Policlinico Sant'Orsola, Bologna
      • Roma, Italy
        • Fondazione Policlinico A Gemelli IRCCS
  • Netherlands
      • Amsterdam, Netherlands
        • Amsterdam UMC
      • Eindhoven, Netherlands
        • Catharina Hospital
      • Enschede, Netherlands
        • Medisch Spectrum Twente
      • Groningen, Netherlands
        • UMCG
      • Leiden, Netherlands
        • Leiden University Medical Center (LUMC)
      • Maastricht, Netherlands
        • Maastricht UMC+
      • Nijmegen, Netherlands
        • Radboud MC
      • Rotterdam, Netherlands
        • Erasmus MC
      • Utrecht, Netherlands
        • UMCU
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1066CX
        • Antoni van Leeuwenhoek
  • Sweden
      • Uppsala, Sweden
        • Alice Bjoernlund-Larsen
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope
    • New York
      • New York, New York, United States, 10065
        • MSKCC New York

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: conventional surgery
Primary cytoreductive surgery without HIPEC
Experimental: HIPEC
Primary cytoreductive surgery with HIPEC with cisplatin
Drug: cisplatin
HIPEC with cisplatin after cytoreductive surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 1 year after last patient last visit
1 year after last patient last visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence-free survival
Time Frame: 1 year after last patient last visit
1 year after last patient last visit
adverse events
Time Frame: 30 days after end of treatment
toxicity of extra treatment compared standaard treatment
30 days after end of treatment
cost evaluation
Time Frame: 1 year after lplv
cost evaluation based measured by quality adjusted life year
1 year after lplv

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Netherlands Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

September 21, 2018

First Submitted That Met QC Criteria

December 10, 2018

First Posted (Actual)

December 11, 2018

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M17OVH
  • ENGOT-ov52/DGOG/OVHIPEC-2 (Other Identifier: European Network of Gynaecological Oncological trials Groups)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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