RecruitingPhase 3NCT03772028

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

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

Sponsor

The Netherlands Cancer Institute

Enrollment

538 participants

Start Date

Jan 1, 2020

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer

Summary

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

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two surgical approaches for advanced ovarian, fallopian tube, or related cancers: standard surgery to remove as much of the tumor as possible, versus that same surgery combined with a heated chemotherapy wash inside the abdomen (called HIPEC — hyperthermic intraperitoneal chemotherapy). Researchers want to know if the heated chemo added during surgery improves outcomes. **You may be eligible if...** - You are a candidate for primary debulking surgery (an operation to remove as much cancer as possible) - You have been diagnosed with stage III ovarian, fallopian tube, or extra-ovarian epithelial cancer confirmed by biopsy or lab test **You may NOT be eligible if...** - You have had another cancer within the past 5 years - Your cancer is stage IV (has spread to distant organs) - Your tumor cannot be fully removed surgically - You have already received treatment for your current cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGcisplatin

HIPEC with cisplatin after cytoreductive surgery

Locations(28)

City of Hope

Duarte, California, United States

MSKCC New York

New York, New York, United States

Rigshospitalet Copenhagen

Copenhagen, Denmark

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, France

Mater Misericordiae University Hospital, Dublin

Dublin, Ireland

Policlinico Sant'Orsola, Bologna

Bologna, Italy

Fondazione Policlinico A Gemelli IRCCS

Roma, Italy

Antoni van leeuwenhoek

Amsterdam, North Holland, Netherlands

Amsterdam UMC

Amsterdam, 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, Netherlands

Alice Bjoernlund-Larsen

Uppsala, Sweden

View Full Details on ClinicalTrials.gov

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NCT03772028

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