Clinical trial NCT03772028: Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Official title: Phase III Randomized Clinical Trial for Stage III Epithelial Ovarian Cancer Randomizing Between Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Ovarian Cancer
Keywords: ovarian cancer
HIPEC
OVHIPEC
primary debulking
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 538
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled, open-label, multicenter phase III trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: overall survival
timeFrame: 1 year after last patient last visit
Secondary outcomes:
measure: recurrence-free survival
timeFrame: 1 year after last patient last visit
measure: adverse events
timeFrame: 30 days after end of treatment
measure: cost evaluation
timeFrame: 1 year after lplv
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: New York
country: United States
facility: MSKCC New York
state: New York
city: Copenhagen
country: Denmark
facility: Rigshospitalet Copenhagen
city: Besançon
country: France
facility: CHU de Besancon
city: Bordeaux
country: France
facility: Institut Bergonié
city: Bordeaux
country: France
facility: o Institut Bergonié, Bordeaux
city: Lille
country: France
facility: CHU Lille
city: Lyon
country: France
facility: Centre Leon Berard, Lyon
city: Lyon
country: France
facility: CHU Lyon
city: Montpellier
country: France
facility: Institut du Cancer Montpellier
city: Nantes
country: France
facility: Institut de Cancerologie de l'Ouest, ICO Nantes)
city: Paris
country: France
facility: Institut Curie Paris
city: Strasbourg
country: France
facility: CHRU Strasbourg
city: Toulouse
country: France
facility: Oncopole, Institute Universitaire du Cancer de Toulouse (IUCT Toulouse)
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital, Dublin
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola, Bologna
city: Roma
country: Italy
facility: Fondazione Policlinico A Gemelli IRCCS
city: Amsterdam
country: Netherlands
facility: Antoni van leeuwenhoek
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Groningen
country: Netherlands
facility: UMCG
city: Leiden
country: Netherlands
facility: Leiden University Medical Center (LUMC)
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
city: Nijmegen
country: Netherlands
facility: Radboud MC
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Utrecht
country: Netherlands
facility: UMCU
city: Uppsala
country: Sweden
facility: Alice Bjoernlund-Larsen
Study officials:
References:
citation: 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.