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Interval Cytoreductive Surgery With or Without HIPEC for Ovarian Cancer (FOCUS / KOV-HIPEC-04) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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)

NCT05827523•National Cancer Center, Korea

View on ClinicalTrials.gov

Summary

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

Detailed Description

The goal of this phase III randomized controlled trial is to compare the clinical efficacy of HIPEC with cisplatin (trial arm) compared to no HIPEC (control arm) during interval cytoreductive surgery followed by neoadjuvant chemotherapy, in patients with stage III-IV primary epithelial ovarian cancer.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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,
+3 more criteria

Locations (10)

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

Key Dates

Start Date

May 31, 2023

Primary Completion Date

December 31, 2027

Completion Date

December 31, 2030

Last Updated

February 13, 2026

Enrollment

520

ESTIMATED participants

Conditions

Ovarian Cancer

Interventions

Cisplatin

DRUG

Contacts

Myong Cheol Lim, MD, Ph.D

CONTACT

+820319201760 gynlim@gmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

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