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NCT05827523RecruitingPhase 3

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)

Source: ClinicalTrials.gov · Last updated 13 Feb 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
520 (estimated)
First submitted
12 Apr 2023
Start date
31 May 2023
Primary completion date
31 Dec 2027
Lead sponsor
National Cancer Center, Korea
NCT number
NCT05827523

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 520
  • From 31 May 2023 to the primary completion date, 31 Dec 2027
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have not undergone neoadjuvant chemotherapy,
  • 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,

Other illness

  • Interval cytoreduction with more than 2.5 mm depth of residual disease,
  • 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,
  • Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML,
  • 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,
  • Patients diagnosed with a psychiatric disorder or substance abuse disorder that would interfere with your ability to cooperate with the trial,
  • Patients with any contraindications to the use of cisplatin (i.e., hypersensitivity to cisplatin),
  • Patients with a history of allogeneic tissue/solid organ transplantation or bone marrow transplantation or a history of double umbilical cord transplantation or,

Lab values

  • 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.

Other

  • Diagnosed with non-epithelial ovarian carcinoma or borderline ovarian tumor
  • A life expectancy ≤3 months as clinically judged,

Who the study is looking for

  • Signed and written informed consent,
  • Patients ≥18, <80 years old,
  • 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,
  • Treated with interval complete cytoreduction, or cytoreduction with no more than 2.5 mm depth of residual disease,
  • A life expectancy > 3 months as clinically judged,
  • Adequate organ function for cytoreductive surgery and HIPEC,
  • Women who are medically unable to conceive or who are of childbearing potential, agree to follow contraceptive guidelines during treatment and,
  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Ilsan CHA University Hospital
Coordinator of this site? Confirm its status
Goyang-siSouth KoreaRecruiting
National Cancer Center
Coordinator of this site? Confirm its status
Goyang-siSouth KoreaRecruiting
Pusan National University Hospital
Coordinator of this site? Confirm its status
PusanSouth KoreaNot yet recruiting
Pusan National University Yangsan Hospital
Coordinator of this site? Confirm its status
PusanSouth KoreaNot yet recruiting
Chungnam National University Hospital
Coordinator of this site? Confirm its status
SejongSouth KoreaNot yet recruiting
Chungnam National University Sejong Hospital
Coordinator of this site? Confirm its status
SejongSouth KoreaNot yet recruiting
Ewha Womans University Mokdong Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaNot yet recruiting
Severance hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Asan Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaNot yet recruiting
Ajou University Hospital
Coordinator of this site? Confirm its status
SuwonSouth KoreaRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.