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Recruiting Phase 3

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

NCT05827523 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 3
Started
2023-05-31
Last updated
2026-02-13

Condition(s) studied

Ovarian Cancer

Investigational drug(s) / intervention(s)

Cisplatin →

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Overall survival (OS) — From randomization to the date of death from any cause, assessed up to 5 years

Trial sites (10)

FacilityCityRegionStatus
Chungnam National University Hospital Sejong Chungcheongnam-do Not Yet Recruiting
Chungnam National University Sejong Hospital Sejong Chungcheongnam-do Not Yet Recruiting
Ilsan CHA University Hospital Goyang-si Gyeonggi-do Recruiting
National Cancer Center Goyang-si Gyeonggi-do Recruiting
Ajou University Hospital Suwon Gyeonggi-do Recruiting
Pusan National University Hospital Pusan South Korea Not Yet Recruiting
Pusan National University Yangsan Hospital Pusan South Korea Not Yet Recruiting
Asan Medical Center Seoul South Korea Not Yet Recruiting
Ewha Womans University Mokdong Hospital Seoul South Korea Not Yet Recruiting
Severance Hospital Seoul South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05827523 on ClinicalTrials.gov ↗ ← All trials in South Korea