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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03772028
Other study ID # M17OVH
Secondary ID ENGOT-ov52/DGOG/
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 1, 2020
Est. completion date April 1, 2026

Study information

Verified date October 2022
Source The Netherlands Cancer Institute
Contact Willemien van Driel, MD, PhD
Phone 031 20 512 7918
Email OVHIPEC@nki.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 538
Est. completion date April 1, 2026
Est. primary completion date April 1, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
cisplatin
HIPEC with cisplatin after cytoreductive surgery

Locations

Country Name City State
Denmark Rigshospitalet Copenhagen Copenhagen
France 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
Ireland Mater Misericordiae University Hospital, Dublin Dublin
Italy Policlinico Sant'Orsola, Bologna Bologna
Italy Fondazione Policlinico A Gemelli IRCCS Roma
Netherlands Amsterdam UMC Amsterdam
Netherlands Antoni van leeuwenhoek Amsterdam Noord-Holland
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
Sweden Alice Bjoernlund-Larsen Uppsala
United States City of Hope Duarte California
United States MSKCC New York New York New York

Sponsors (1)

Lead Sponsor Collaborator
The Netherlands Cancer Institute

Countries where clinical trial is conducted

United States,  Denmark,  France,  Ireland,  Italy,  Netherlands,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary overall survival 1 year after last patient last visit
Secondary recurrence-free survival 1 year after last patient last visit
Secondary adverse events toxicity of extra treatment compared standaard treatment 30 days after end of treatment
Secondary cost evaluation cost evaluation based measured by quality adjusted life year 1 year after lplv
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