Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

Interval Cytoreductive Surgery With or Without HIPEC for Ovarian Cancer (FOCUS / KOV-HIPEC-04)

Phase III Randomized Trial of HIPEC in Primary Stage Three & Four Primary Ovarian Cancer After Interval Cytoreductive Surgery (FOCUS, KOV-04)

Interval Cytoreductive Surgery With or Without HIPEC for Ovarian Cancer (FOCUS / KOV-HIPEC-04) (NCT05827523) is a Phase 3 interventional studying Ovarian Cancer, sponsored by National Cancer Center, Korea. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

Primary stage III-IV epithelial ovarian cancer randomizing between interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC)

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Ovarian Cancer, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 520 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Signed and written willing to sign a consent form, 2. Patients ≥18, \<80 years old, 3. Diagnosed with diagnosed by tissue sample (biopsy-confirmed) FIGO stage III-IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer treated with three cycles of neoadjuvant chemotherapy, 4. Treated with interval complete cytoreduction, or cytoreduction with no more than 2.5 mm depth of residual disease, 5. A life expectancy \> 3 months as clinically judged, 6. your organs (liver, kidneys, etc.) are working well enough based on blood tests for cytoreductive surgery and HIPEC, 7. Women who are medically unable to conceive or who are of childbearing potential, agree to follow contraceptive guidelines during treatment and, 8. Patients 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. Who Should NOT Join This Trial: 1. Diagnosed with non-epithelial ovarian carcinoma or borderline ovarian tumor 2. Patients who have not undergone neoadjuvant chemotherapy, 3. Interval cytoreduction with more than 2.5 mm depth of residual disease, 4. A life expectancy ≤3 months as clinically judged, 5. History of previous malignancy within five years prior to inclusion, that affects ovarian cancer treatment results, with the exception of carcinoma in situ, radically excised basal cell or squamous cell cancer of the skin, or synchronal endometrial carcinoma FIGO IA G1/2, 6. Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML, 7. 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, ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Signed and written informed consent, 2. Patients ≥18, \<80 years old, 3. Diagnosed with histologically confirmed FIGO stage III-IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer treated with three cycles of neoadjuvant chemotherapy, 4. Treated with interval complete cytoreduction, or cytoreduction with no more than 2.5 mm depth of residual disease, 5. A life expectancy \> 3 months as clinically judged, 6. Adequate organ function for cytoreductive surgery and HIPEC, 7. Women who are medically unable to conceive or who are of childbearing potential, agree to follow contraceptive guidelines during treatment and, 8. Patients 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. Exclusion Criteria: 1. Diagnosed with non-epithelial ovarian carcinoma or borderline ovarian tumor 2. Patients who have not undergone neoadjuvant chemotherapy, 3. Interval cytoreduction with more than 2.5 mm depth of residual disease, 4. A life expectancy ≤3 months as clinically judged, 5. History of previous malignancy within five years prior to inclusion, that affects ovarian cancer treatment results, with the exception of carcinoma in situ, radically excised basal cell or squamous cell cancer of the skin, or synchronal endometrial carcinoma FIGO IA G1/2, 6. Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML, 7. 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, 8. Patients with antibacterial, antifungal, or antiviral infections requiring systemic treatment (administration of parenteral antibiotics), 9. Active tuberculosis that is not controlled within 1 month of treatment, 10. Patients diagnosed with a psychiatric disorder or substance abuse disorder that would interfere with your ability to cooperate with the trial, 11. Patients with any contraindications to the use of cisplatin (i.e., hypersensitivity to cisplatin), 12. Patients with a history of allogeneic tissue/solid organ transplantation or bone marrow transplantation or a history of double umbilical cord transplantation or, 13. History or current evidence of any condition, therapy, or laboratory abnormality that may confound the results of the study, or interfere with the patient's participation, in the opinion of the treating investigator.

Treatments Being Tested

DRUG

Cisplatin

Hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin 75mg/m2 after interval cytoreductive surgery

Locations (10)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Chungnam National University Hospital

Sejong, Chungcheongnam-do, South Korea

Chungnam National University Sejong Hospital

Sejong, Chungcheongnam-do, South Korea

Ilsan CHA University Hospital

Goyang-si, Gyeonggi-do, South Korea

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Pusan National University Hospital

Pusan, South Korea

Pusan National University Yangsan Hospital

Pusan, South Korea

Asan Medical Center

Seoul, South Korea

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05827523), the sponsor (National Cancer Center, Korea), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05827523 clinical trial studying?

Primary stage III-IV epithelial ovarian cancer randomizing between interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05827523?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05827523?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05827523. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05827523. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.