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Phase III Randomized Clinical Trial for Stage III Epithelial Ovarian Cancer Randomizing Between Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy
stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
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
Start Date
January 1, 2020
Primary Completion Date
April 1, 2025
Completion Date
April 1, 2026
Last Updated
September 8, 2023
538
ESTIMATED participants
cisplatin
DRUG
Lead Sponsor
The Netherlands Cancer Institute
NCT04550494
NCT05039801
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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