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Epithelial Ovarian CancerPhase 3KOV-HIPEC-02RNCT05316181

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

A Phase 3 study testing HIPEC in people with Epithelial Ovarian Cancer and Platinum Resistant, run by National Cancer Center, Korea at 3 sites in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older, women only
What is being tested?
HIPEC
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
3 sitesSouth Korea
Study dates
7 Apr 2022to 31 Dec 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
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  • 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

Who cannot join

  • 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,
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  • 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.

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

  • Myong Cheol Lim

    Goyang-si, Gyeonggi-do, 10408

  • Ewha Womans University Mokdong Hospital

    Seoul

  • Korea University Anam hospital

    Seoul

Other trials in South Korea

About this study

Official title: 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

Read the 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.

Being tested
HIPEC
Keywords
Ovarian cancer, Hyperthermic intraperitoneal chemotherapy, HIPEC, Recurrent ovarian cancer, Cytoreductive surgery, Platinum-Resistant, Doxorubicin, Mitymycin
Medical subject headings
Carcinoma, Ovarian Epithelial, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIPECProcedure or surgery

    HIPEC perfusion, doxorubicin 35mg/m2 \& mitomycin 15 mg/m2, 41.5'C, 90 min.

Study groups in NCT05316181
Study groupRoleWhat they receive
Cytoreductive surgery and HIPECExperimentalCytoreductive surgery + Hyperthermic Intraperitoneal Chemotherapy (HIPEC) followed by physician-choice chemotherapy until disease progression.
Receives: Procedure: HIPEC
No HIPECNo interventionPhysician-choice chemotherapy from enrollment until disease progression.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    Measured: From randomization to time of first progression or death from any cause, whichever came first, assessed up to 5 years

Secondary outcomes (7)

  1. Overall survival (OS)

    Measured: From randomization to the date of death from any cause, assessed up to 5 years

  2. cancer-specific survival

    Measured: From randomization to the date of death due to ovarian cancer, assessed up to 5 years

  3. Treatment-related adverse events

    assessed by CTCAE ver.5.0

    Measured: From randomization up to the end of treatment plus 6 weeks

  4. Health-related quality of life (QLQ C30)

    assessed by EEuropean Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Score 30 (QLQ-C30)

    Measured: Over the 5 year surveillance period

  5. Health-related quality of life (QLQ OV28)

    assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Ovarian Cancer Module (QLQ-OV28)

    Measured: Over the 5 year surveillance period

  6. Health-related quality of life (EQ-5D-5L)

    assessed by the 5-level EQ-5D version (EQ-5D-5L)

    Measured: Over the 5 year surveillance period

  7. Cost-effectiveness analysis

    assessed by Quality-Adjusted Live Years (QALYs)

    Measured: At time of completion of 5-year surveillance period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2022
  2. Study start7 Apr 2022
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled, open-label, multicenter phase III trial
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05316181
Sponsor's protocol ID
NCC2021-0334
Acronym
KOV-HIPEC-02R
Status last verified
Dec 2025
First submitted
3 Mar 2022
Last updated
12 Feb 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Kim JH, Park E, Park SY, Lim MC. A randomized, multicenter, open-label phase III trial of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in platinum-resistant recurrent ovarian cancer: a rationale and study design of the KOV-HIPEC-02 trial. Int J Gynecol Cancer. 2025 Apr;35(4):101630. doi: 10.1016/j.ijgc.2025.101630. Epub 2025 Jan 9.

    PubMed 39955184

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HIPEC in people with Epithelial Ovarian Cancer and Platinum Resistant, run by National Cancer Center, Korea at 3 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05316181, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.

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