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

Sponsor
The Netherlands Cancer Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT03772028
Collaborator
(none)
538
Enrollment
21
Locations
2
Arms
75
Anticipated Duration (Months)
25.6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
538 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized controlled, open-label, multicenter phase III trialrandomized controlled, open-label, multicenter phase III trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase III Randomized Clinical Trial for Stage III Epithelial Ovarian Cancer Randomizing Between Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy
Actual Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Apr 1, 2026

Arms and Interventions

Arm Intervention/Treatment
No Intervention: conventional surgery

Primary cytoreductive surgery without HIPEC
Experimental: HIPEC

Primary cytoreductive surgery with HIPEC with cisplatin

Drug: cisplatin
HIPEC with cisplatin after cytoreductive surgery

Outcome Measures

Primary Outcome Measures

  1. overall survival [1 year after last patient last visit]

Secondary Outcome Measures

  1. recurrence-free survival [1 year after last patient last visit]

  2. adverse events [30 days after end of treatment]

    toxicity of extra treatment compared standaard treatment

  3. cost evaluation [1 year after lplv]

    cost evaluation based measured by quality adjusted life year

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 MSKCC New York New York New York United States 10065
2 Rigshospitalet Copenhagen Copenhagen Denmark
3 o Institut Bergonié, Bordeaux Bordeaux France
4 Centre Leon Berard, Lyon Lyon France
5 CHU Lyon Lyon France
6 Institut du Cancer Montpellier Montpellier France
7 Institut de Cancerologie de l'Ouest, ICO Nantes) Nantes France
8 Oncopole, Institute Universitaire du Cancer de Toulouse (IUCT Toulouse) Toulouse France
9 Mater Misericordiae University Hospital, Dublin Dublin Ireland
10 Policlinico Sant'Orsola, Bologna Bologna Italy
11 Fondazione Policlinico A Gemelli IRCCS Roma Italy
12 Antoni van leeuwenhoek Amsterdam Noord-Holland Netherlands 1066CX
13 Amsterdam UMC Amsterdam Netherlands
14 Catharina Hospital Eindhoven Netherlands
15 Medisch Spectrum Twente Enschede Netherlands
16 UMCG Groningen Netherlands
17 Leiden University Medical Center (LUMC) Leiden Netherlands
18 Maastricht UMC+ Maastricht Netherlands
19 Radboud MC Nijmegen Netherlands
20 Erasmus MC Rotterdam Netherlands
21 Alice Bjoernlund-Larsen Uppsala Sweden

Sponsors and Collaborators

  • The Netherlands Cancer Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Netherlands Cancer Institute
ClinicalTrials.gov Identifier:
NCT03772028
Other Study ID Numbers:
  • M17OVH
  • ENGOT-ov52/DGOG/OVHIPEC-2
First Posted:
Dec 11, 2018
Last Update Posted:
May 26, 2022
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The Netherlands Cancer Institute
ovarian cancer
HIPEC
OVHIPEC
primary debulking
Additional relevant MeSH terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Cisplatin

Study Results

No Results Posted as of May 26, 2022