CRS & HIPEC for Platinum-Resistant Recurrent Ovarian Cancer (KOV-02R, RECOVER) (KOV-HIPEC-02R)

February 11, 2026 updated by: Myong Cheol Lim, MD, PhD, National Cancer Center, Korea

Randomized Phase III Trial of Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Platinum-Resistant Recurrent Ovarian Cancer: KOV-02R - Resistant Cancer of Ovary (RECOVER)

Platinum-resistant recurrent epithelial ovarian cancer randomizing with or without cytoreductive surgery + hyperthermic intraperitoneal chemotherapy (HIPEC): KOV-02R, RECOVER

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of this trial (KOV-HIPEC-02R) is to prove the survival benefit of HIPEC with doxorubicin and mitomycin (trial arm) compared to physician-choice chemotherapy (control arm) in patients with platinum-resistant recurrent epithelial ovarian cancer.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea
        • Korea University Anam Hospital
      • Seoul, South Korea
        • Ewha Womans University Mokdong Hospital
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, South Korea, 10408
        • Myong Cheol Lim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

  • Inclusion Criteria:

    • Patients ≥18 years old,
    • Patients with Eastern Cooperative Oncology Group (ECOG) Performance status 0-2,
    • Patients diagnosed with histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer,
    • Resistant to platinum-based chemotherapy (Platinum-refractory or resistant disease)
    • Resectable intraperitoneal disease based on previous clinical history and recent image finding,
    • A life expectancy > 3 months as clinically judged,
    • Women who are medically unable to conceive or who are of childbearing potential, agree to follow contraceptive guidelines during treatment,
    • Patient can also consent to the provision of clinical information for secondary use such as future biomedical research. However, in the future, subjects can participate in the main trial even if they do not intend to participate in sharing clinical information and,
    • Adequate organ function for cytoreductive surgery and HIPEC

  • Exclusion criteria:

    • Non-epithelial ovarian carcinoma,
    • Borderline ovarian tumor,
    • Patients who are not appropriate for surgical and HIPEC procedures based on previous surgery or clinical findings, including severe intestinal adhesions, obstruction, or abdominal fistula,
    • Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML,
    • Patients which extra-abdominal disease is a major disease or is expected to cause of death,
    • Patients with active central nervous system metastasis and carcinoma meningitis or patients who have been previously treated for brain metastases must be in a stable state in radiology,
    • Patients with antibacterial, antifungal, or antiviral infections requiring systemic treatment (administration of parenteral antibiotics),
    • Active tuberculosis that is not controlled within 1 month of treatment,
    • Patient diagnosed with a psychiatric disorder or substance abuse disorder that would interfere with your ability to cooperate with the trial,
    • Patients who have not undergone hysterectomy and have a positive urine pregnancy test result within 14 days prior to clinical trial assignment, even if the urine pregnancy test result is negative at screening,
    • Pregnant or lactating women,
    • Patients with any contraindications to the use of doxorubicin or mitomycin (i.e., hypersensitivity to doxorubicin or mitomycin),
    • Patients with a history of allogeneic tissue/solid organ transplantation or bone marrow transplantation or a history of double umbilical cord transplantation or,
    • History or current evidence of any condition, therapy, or laboratory abnormality that may confound the results of the study, interfere with the patient's participation, in the opinion of the treating investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No HIPEC
Physician-choice chemotherapy from enrollment until disease progression.
Experimental: Cytoreductive surgery and HIPEC
Cytoreductive surgery + Hyperthermic Intraperitoneal Chemotherapy (HIPEC) followed by physician-choice chemotherapy until disease progression.
Procedure: HIPEC
HIPEC perfusion, doxorubicin 35mg/m2 & mitomycin 15 mg/m2, 41.5'C, 90 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: From randomization to time of first progression or death from any cause, whichever came first, assessed up to 5 years
From randomization to time of first progression or death from any cause, whichever came first, assessed up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: From randomization to the date of death from any cause, assessed up to 5 years
From randomization to the date of death from any cause, assessed up to 5 years
cancer-specific survival
Time Frame: From randomization to the date of death due to ovarian cancer, assessed up to 5 years
From randomization to the date of death due to ovarian cancer, assessed up to 5 years
Treatment-related adverse events
Time Frame: From randomization up to the end of treatment plus 6 weeks
assessed by CTCAE ver.5.0
From randomization up to the end of treatment plus 6 weeks
Health-related quality of life (QLQ C30)
Time Frame: Over the 5 year surveillance period
assessed by EEuropean Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Score 30 (QLQ-C30)
Over the 5 year surveillance period
Health-related quality of life (QLQ OV28)
Time Frame: Over the 5 year surveillance period
assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Ovarian Cancer Module (QLQ-OV28)
Over the 5 year surveillance period
Health-related quality of life (EQ-5D-5L)
Time Frame: Over the 5 year surveillance period
assessed by the 5-level EQ-5D version (EQ-5D-5L)
Over the 5 year surveillance period
Cost-effectiveness analysis
Time Frame: At time of completion of 5-year surveillance period
assessed by Quality-Adjusted Live Years (QALYs)
At time of completion of 5-year surveillance period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

March 3, 2022

First Submitted That Met QC Criteria

March 30, 2022

First Posted (Actual)

April 7, 2022

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC2021-0334

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epithelial Ovarian Cancer

Clinical Trials on HIPEC

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe