NCT03772028

Brief Summary

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

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
538

participants targeted

Target at P50-P75 for phase_3 ovarian-cancer

Timeline
31mo left

Started Jan 2020

Longer than P75 for phase_3 ovarian-cancer

Geographic Reach
7 countries

28 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Jan 2020Dec 2028

First Submitted

Initial submission to the registry

September 21, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

8.3 years

First QC Date

September 21, 2018

Last Update Submit

April 2, 2026

Conditions

Ovarian Cancer

Keywords

ovarian cancerHIPECOVHIPECprimary debulking

Outcome Measures

Primary Outcomes (1)

  • overall survival

    1 year after last patient last visit

Secondary Outcomes (3)

  • recurrence-free survival

    1 year after last patient last visit

  • adverse events

    30 days after end of treatment

  • cost evaluation

    1 year after lplv

Study Arms (2)

conventional surgery

NO INTERVENTION

Primary cytoreductive surgery without HIPEC

HIPEC

EXPERIMENTAL

Primary cytoreductive surgery with HIPEC with cisplatin

Drug: cisplatin

Interventions

cisplatinDRUG

HIPEC with cisplatin after cytoreductive surgery

HIPEC

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsovarian cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • FIGO stage IV disease
  • complete primary cytoreduction is impossible
  • prior treatment for the current malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

City of Hope

Duarte, California, 91010, United States

Location

MSKCC New York

New York, New York, 10065, United States

Location

Rigshospitalet Copenhagen

Copenhagen, Denmark

Location

CHU de Besancon

Besançon, France

Location

Institut Bergonié

Bordeaux, France

Location

o Institut Bergonié, Bordeaux

Bordeaux, France

Location

CHU Lille

Lille, France

Location

Centre Leon Berard, Lyon

Lyon, France

Location

CHU Lyon

Lyon, France

Location

Institut du Cancer Montpellier

Montpellier, France

Location

Institut de Cancerologie de l'Ouest, ICO Nantes)

Nantes, France

Location

Institut Curie Paris

Paris, France

Location

CHRU Strasbourg

Strasbourg, France

Location

Oncopole, Institute Universitaire du Cancer de Toulouse (IUCT Toulouse)

Toulouse, France

Location

Mater Misericordiae University Hospital, Dublin

Dublin, Ireland

Location

Policlinico Sant'Orsola, Bologna

Bologna, Italy

Location

Fondazione Policlinico A Gemelli IRCCS

Roma, Italy

Location

Antoni van leeuwenhoek

Amsterdam, North Holland, 1066CX, Netherlands

Location

Amsterdam UMC

Amsterdam, Netherlands

Location

Catharina Hospital

Eindhoven, Netherlands

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

UMCG

Groningen, Netherlands

Location

Leiden University Medical Center (LUMC)

Leiden, Netherlands

Location

Maastricht UMC+

Maastricht, Netherlands

Location

Radboud MC

Nijmegen, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

UMCU

Utrecht, Netherlands

Location

Alice Bjoernlund-Larsen

Uppsala, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 32205449DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled, open-label, multicenter phase III trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2018

First Posted

December 11, 2018

Study Start

January 1, 2020

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations

US(2)DK(1)SE(1)IT(2)FR(11)NL(10)IE(1)