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Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (OVHIPEC-2)

Primary Purpose

Ovarian Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
cisplatin
Sponsored by
The Netherlands Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian cancer, HIPEC, OVHIPEC, primary debulking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • City of HopeRecruiting
  • MSKCC New YorkRecruiting
  • Rigshospitalet CopenhagenRecruiting
  • CHU de BesanconRecruiting
  • Institut BergoniéRecruiting
  • o Institut Bergonié, BordeauxRecruiting
  • CHU LilleRecruiting
  • Centre Leon Berard, LyonRecruiting
  • CHU LyonRecruiting
  • Institut du Cancer MontpellierRecruiting
  • Institut de Cancerologie de l'Ouest, ICO Nantes)Recruiting
  • Institut Curie ParisRecruiting
  • CHRU StrasbourgRecruiting
  • Oncopole, Institute Universitaire du Cancer de Toulouse (IUCT Toulouse)Recruiting
  • Mater Misericordiae University Hospital, DublinRecruiting
  • Policlinico Sant'Orsola, BolognaRecruiting
  • Fondazione Policlinico A Gemelli IRCCSRecruiting
  • Antoni van leeuwenhoekRecruiting
  • Amsterdam UMCRecruiting
  • Catharina HospitalRecruiting
  • Medisch Spectrum TwenteRecruiting
  • UMCGRecruiting
  • Leiden University Medical Center (LUMC)Recruiting
  • Maastricht UMC+Recruiting
  • Radboud MCRecruiting
  • Erasmus MCRecruiting
  • UMCURecruiting
  • Alice Bjoernlund-LarsenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

conventional surgery

HIPEC

Arm Description

Primary cytoreductive surgery without HIPEC

Primary cytoreductive surgery with HIPEC with cisplatin

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

recurrence-free survival
adverse events
toxicity of extra treatment compared standaard treatment
cost evaluation
cost evaluation based measured by quality adjusted life year

Full Information

First Posted
September 21, 2018
Last Updated
September 7, 2023
Sponsor
The Netherlands Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03772028
Brief Title
Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Acronym
OVHIPEC-2
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
April 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Netherlands Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
ovarian cancer, HIPEC, OVHIPEC, primary debulking

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled, open-label, multicenter phase III trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
538 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional surgery
Arm Type
No Intervention
Arm Description
Primary cytoreductive surgery without HIPEC
Arm Title
HIPEC
Arm Type
Experimental
Arm Description
Primary cytoreductive surgery with HIPEC with cisplatin
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
HIPEC with cisplatin after cytoreductive surgery
Primary Outcome Measure Information:
Title
overall survival
Time Frame
1 year after last patient last visit
Secondary Outcome Measure Information:
Title
recurrence-free survival
Time Frame
1 year after last patient last visit
Title
adverse events
Description
toxicity of extra treatment compared standaard treatment
Time Frame
30 days after end of treatment
Title
cost evaluation
Description
cost evaluation based measured by quality adjusted life year
Time Frame
1 year after lplv

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
ovarian cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Willemien van Driel, MD, PhD
Phone
031 20 512 7918
Email
OVHIPEC@nki.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Lot Aronson
Phone
031 20 512 7918
Email
OVHIPEC@nki.nl
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thanh Dellinger, MD
Phone
626-256-4673
Ext
95200
Facility Name
MSKCC New York
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bhavani Ramesh
Email
rameshb@mskcc.org
First Name & Middle Initial & Last Name & Degree
Oliver Zivanovic
Facility Name
Rigshospitalet Copenhagen
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Bjoernlund-Larsen
Email
alice.bjoernlund-larsen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Berit Jul Mosgaard
Facility Name
CHU de Besancon
City
Besançon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nabila Bouazza
Email
Nabila.Bouazza@icm.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Laura Mansi
Facility Name
Institut Bergonié
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nabila Bouazza
Email
Nabila.Bouazza@icm.unicancer.fr
First Name & Middle Initial & Last Name & Degree
F. Guyon
Facility Name
o Institut Bergonié, Bordeaux
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nabila Bouazza
Email
Nabila.Bouazza@icm.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Frederic Guyon, Dr
Facility Name
CHU Lille
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nabila Bouazza
Email
Nabila.Bouazza@icm.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Clarisse Eveno
Facility Name
Centre Leon Berard, Lyon
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nabila B Bouazza
Email
Nabila.Bouazza@icm.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Pierre Meeus, Dr
Facility Name
CHU Lyon
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nabila B Bouazza
Email
Nabila.Bouazza@icm.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Naoual Bakrin
Facility Name
Institut du Cancer Montpellier
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nabila Bouazza
Email
Nabila.Bouazza@icm.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Pierre-Emmanuel Colombo, MD
Facility Name
Institut de Cancerologie de l'Ouest, ICO Nantes)
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nabila Bouazza
Email
Nabila.Bouazza@icm.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Charlotte Bourgin
Facility Name
Institut Curie Paris
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nabila Bouazza
Email
Nabila.Bouazza@icm.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Jean Guillaume FERON
Facility Name
CHRU Strasbourg
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nabila Bouazza
Email
Nabila.Bouazza@icm.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Cherif Akladios
Facility Name
Oncopole, Institute Universitaire du Cancer de Toulouse (IUCT Toulouse)
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nabila Bouazza
Email
Nabila.Bouazza@icm.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Ferron Gwenael
Facility Name
Mater Misericordiae University Hospital, Dublin
City
Dublin
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terri Martin
Email
tmartin@mater.ie
First Name & Middle Initial & Last Name & Degree
Donal Brennan
Facility Name
Policlinico Sant'Orsola, Bologna
City
Bologna
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierandrea De Iaco
Facility Name
Fondazione Policlinico A Gemelli IRCCS
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Deamicis
Email
andrea.deamicis@policlinicogemelli.it
First Name & Middle Initial & Last Name & Degree
Anna Fagotti
Facility Name
Antoni van leeuwenhoek
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1066CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lot Aronson, PhD student
Email
l.aronson@nki.nl
First Name & Middle Initial & Last Name & Degree
Ruby van Stein, PhD student
Email
r.v.stein@nki.nl
First Name & Middle Initial & Last Name & Degree
Willemien van Driel, dr
Facility Name
Amsterdam UMC
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Catharina Hospital
City
Eindhoven
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
UMCG
City
Groningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Leiden University Medical Center (LUMC)
City
Leiden
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Maastricht UMC+
City
Maastricht
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Radboud MC
City
Nijmegen
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Erasmus MC
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
UMCU
City
Utrecht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
H.W.R. Schreuder, MD
Email
H.W.R.Schreuder@umcutrecht.nl
Facility Name
Alice Bjoernlund-Larsen
City
Uppsala
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Bjoernlund-Larsen
Email
alice.bjoernlund-larsen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Marta Lomnytska

12. IPD Sharing Statement

Citations:
PubMed Identifier
32205449
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.
Results Reference
derived

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

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