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

NCT ID: NCT03772028

Last Updated: 2023-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

538 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2026-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ovarian Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled, open-label, multicenter phase III trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

conventional surgery

Primary cytoreductive surgery without HIPEC

Group Type NO_INTERVENTION

No interventions assigned to this group

HIPEC

Primary cytoreductive surgery with HIPEC with cisplatin

Group Type EXPERIMENTAL

cisplatin

Intervention Type DRUG

HIPEC with cisplatin after cytoreductive surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cisplatin

HIPEC with cisplatin after cytoreductive surgery

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Netherlands Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

City of Hope

Duarte, California, United States

Site Status RECRUITING

MSKCC New York

New York, New York, United States

Site Status RECRUITING

Rigshospitalet Copenhagen

Copenhagen, , Denmark

Site Status RECRUITING

CHU de Besancon

Besançon, , France

Site Status RECRUITING

Institut Bergonié

Bordeaux, , France

Site Status RECRUITING

o Institut Bergonié, Bordeaux

Bordeaux, , France

Site Status RECRUITING

CHU Lille

Lille, , France

Site Status RECRUITING

Centre Leon Berard, Lyon

Lyon, , France

Site Status RECRUITING

CHU Lyon

Lyon, , France

Site Status RECRUITING

Institut du Cancer Montpellier

Montpellier, , France

Site Status RECRUITING

Institut de Cancerologie de l'Ouest, ICO Nantes)

Nantes, , France

Site Status RECRUITING

Institut Curie Paris

Paris, , France

Site Status RECRUITING

CHRU Strasbourg

Strasbourg, , France

Site Status RECRUITING

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

Toulouse, , France

Site Status RECRUITING

Mater Misericordiae University Hospital, Dublin

Dublin, , Ireland

Site Status RECRUITING

Policlinico Sant'Orsola, Bologna

Bologna, , Italy

Site Status RECRUITING

Fondazione Policlinico A Gemelli IRCCS

Roma, , Italy

Site Status RECRUITING

Antoni van leeuwenhoek

Amsterdam, North Holland, Netherlands

Site Status RECRUITING

Amsterdam UMC

Amsterdam, , Netherlands

Site Status RECRUITING

Catharina Hospital

Eindhoven, , Netherlands

Site Status RECRUITING

Medisch Spectrum Twente

Enschede, , Netherlands

Site Status RECRUITING

UMCG

Groningen, , Netherlands

Site Status RECRUITING

Leiden University Medical Center (LUMC)

Leiden, , Netherlands

Site Status RECRUITING

Maastricht UMC+

Maastricht, , Netherlands

Site Status RECRUITING

Radboud MC

Nijmegen, , Netherlands

Site Status RECRUITING

Erasmus MC

Rotterdam, , Netherlands

Site Status RECRUITING

UMCU

Utrecht, , Netherlands

Site Status RECRUITING

Alice Bjoernlund-Larsen

Uppsala, , Sweden

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Denmark France Ireland Italy Netherlands Sweden

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Willemien van Driel, MD, PhD

Role: CONTACT

031 20 512 7918

Lot Aronson

Role: CONTACT

031 20 512 7918

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Thanh Dellinger, MD

Role: primary

626-256-4673 ext. 95200

Bhavani Ramesh

Role: primary

Alice Bjoernlund-Larsen

Role: primary

Nabila Bouazza

Role: primary

Nabila Bouazza

Role: primary

Nabila Bouazza

Role: primary

Nabila Bouazza

Role: primary

Nabila B Bouazza

Role: primary

Nabila B Bouazza

Role: primary

Nabila Bouazza

Role: primary

Nabila Bouazza

Role: primary

Nabila Bouazza

Role: primary

Nabila Bouazza

Role: primary

Nabila Bouazza

Role: primary

Terri Martin

Role: primary

Andrea Deamicis

Role: primary

Lot Aronson, PhD student

Role: primary

Ruby van Stein, PhD student

Role: backup

H.W.R. Schreuder, MD

Role: primary

Alice Bjoernlund-Larsen

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32205449 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ENGOT-ov52/DGOG/OVHIPEC-2

Identifier Type: OTHER

Identifier Source: secondary_id

M17OVH

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

HOT: HIPEC in Ovarian Cancer as Initial Treatment
NCT02124421 ACTIVE_NOT_RECRUITING PHASE2