Status:
RECRUITING
Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Lead Sponsor:
The Netherlands Cancer Institute
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 H...
Eligibility Criteria
Inclusion
- candidate for primary CRS
- histological or cytological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
538 Patients enrolled
Trial Details
Trial ID
NCT03772028
Start Date
January 1 2020
End Date
April 1 2026
Last Update
September 8 2023
Active Locations (28)
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1
City of Hope
Duarte, California, United States, 91010
2
MSKCC New York
New York, New York, United States, 10065
3
Rigshospitalet Copenhagen
Copenhagen, Denmark
4
CHU de Besancon
Besançon, France