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

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ClinicalTrials.gov Identifier: NCT03772028
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : October 18, 2022
Information provided by (Responsible Party):
The Netherlands Cancer Institute

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

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: cisplatin 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 538 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized 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 : January 1, 2020
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : April 1, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

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

Primary Outcome Measures :
  1. overall survival [ Time Frame: 1 year after last patient last visit ]

Secondary Outcome Measures :
  1. recurrence-free survival [ Time Frame: 1 year after last patient last visit ]
  2. adverse events [ Time Frame: 30 days after end of treatment ]
    toxicity of extra treatment compared standaard treatment

  3. cost evaluation [ Time Frame: 1 year after lplv ]
    cost evaluation based measured by quality adjusted life year

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   ovarian cancer
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772028

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Contact: Willemien van Driel, MD, PhD 031 20 512 7918 OVHIPEC@nki.nl
Contact: Lot Aronson 031 20 512 7918 OVHIPEC@nki.nl

Show Show 21 study locations
Sponsors and Collaborators
The Netherlands Cancer Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT03772028    
Other Study ID Numbers: M17OVH
ENGOT-ov52/DGOG/OVHIPEC-2 ( Other Identifier: European Network of Gynaecological Oncological trials Groups )
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: October 18, 2022
Last Verified: October 2022

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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
primary debulking
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents