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

Phase 3

Recruiting

• Conditions: Ovarian Cancer
• Interventions: Drug: cisplatin

• Registration Number: NCT03772028
• Lead Sponsor: The Netherlands Cancer Institute

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-09-21
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-11
• Study Start: 2020-01-01
• Status Verified: 2022-10
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-08
• Primary Completion: 2025-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 538

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIPEC	cisplatin	Primary cytoreductive surgery with HIPEC with cisplatin

Primary Outcome Measures

Name	Time	Method
overall survival	1 year after last patient last visit

Secondary Outcome Measures

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

Trial Locations

Locations (28)

Amsterdam UMC; 🇳🇱 Amsterdam, Netherlands

Maastricht UMC+; 🇳🇱 Maastricht, Netherlands

Mater Misericordiae University Hospital, Dublin; 🇮🇪 Dublin, Ireland

Rigshospitalet Copenhagen; 🇩🇰 Copenhagen, Denmark

Institut Bergonié; 🇫🇷 Bordeaux, France

CHU de Besancon; 🇫🇷 Besançon, France

CHU Lille; 🇫🇷 Lille, France

o Institut Bergonié, Bordeaux; 🇫🇷 Bordeaux, France

Fondazione Policlinico A Gemelli IRCCS; 🇮🇹 Roma, Italy

Centre Leon Berard, Lyon; 🇫🇷 Lyon, France

CHU Lyon; 🇫🇷 Lyon, France

Oncopole, Institute Universitaire du Cancer de Toulouse (IUCT Toulouse); 🇫🇷 Toulouse, France

Institut du Cancer Montpellier; 🇫🇷 Montpellier, France

CHRU Strasbourg; 🇫🇷 Strasbourg, France

Leiden University Medical Center (LUMC); 🇳🇱 Leiden, Netherlands

Erasmus MC; 🇳🇱 Rotterdam, Netherlands

Radboud MC; 🇳🇱 Nijmegen, Netherlands

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands

UMCU; 🇳🇱 Utrecht, Netherlands

City of Hope; 🇺🇸 Duarte, California, United States

MSKCC New York; 🇺🇸 New York, New York, United States

Institut Curie Paris; 🇫🇷 Paris, France

Institut de Cancerologie de l'Ouest, ICO Nantes); 🇫🇷 Nantes, France

Policlinico Sant'Orsola, Bologna; 🇮🇹 Bologna, Italy

Antoni van leeuwenhoek; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Catharina Hospital; 🇳🇱 Eindhoven, Netherlands

UMCG; 🇳🇱 Groningen, Netherlands

Alice Bjoernlund-Larsen; 🇸🇪 Uppsala, Sweden