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

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

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

Study Overview

• Status: Recruiting
• Conditions: Ovarian Cancer
• Intervention / Treatment: Drug: Cisplatin

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.

• Study Type: Interventional
• Enrollment (Estimated): 520
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Myong Cheol Lim, MD, Ph.D; Phone Number: +820319201760; Email: gynlim@gmail.com

Study Locations

• South Korea
  • Pusan, South Korea
    • Not yet recruiting
    • Pusan National University Hospital
  • Pusan, South Korea
    • Not yet recruiting
    • Pusan National University Yangsan Hospital
  • Seoul, South Korea
    • Recruiting
    • Severance Hospital
  • Seoul, South Korea
    • Not yet recruiting
    • Asan Medical Center
  • Seoul, South Korea
    • Not yet recruiting
    • Ewha Womans University Mokdong Hospital
  • Chungcheongnam-do
    • Sejong, Chungcheongnam-do, South Korea
      • Not yet recruiting
      • Chungnam National University Hospital
    • Sejong, Chungcheongnam-do, South Korea
      • Not yet recruiting
      • Chungnam National University Sejong Hospital
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, South Korea
      • Recruiting
      • Ilsan CHA University Hospital
    • Goyang-si, Gyeonggi-do, South Korea
      • Recruiting
      • National Cancer Center
      • Contact: Myong Cheol Lim, MD, PhD; Phone Number: +820319201760; Email: gynlim@gmail.com
      • Contact: Ji Hyun Kim, MD; Email: gynlittle@gmail.com
      • Principal Investigator: Myong Cheol Lim
    • Suwon, Gyeonggi-do, South Korea
      • Recruiting
      • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIPEC; Interval cytoreductive surgery with HIPEC	Drug: Cisplatin; Hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin 75mg/m2 after interval cytoreductive surgery
No Intervention: No HIPEC; Interval cytoreductive surgery without HIPEC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival (OS)	From randomization to the date of death from any cause, assessed up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)		From randomization to time of first progression or death from any cause, whichever came first, assessed up to 5 years
Cancer-specific survival		From randomization to the date of death due to ovarian cancer, assessed up to 5 years
Time to first subsequent therapy (TFST)	the interval from the last day of the last cycle of a prior regimen of chemotherapy to the first day of the first cycle of the subsequent regimen for each course of chemotherapy	from the last day of the last cycle of a prior regimen of chemotherapy to the first day of the first cycle of the subsequent chemotherapy, assessed up to 5 years
Treatment-related adverse events	assessed by CTCAE ver.5.0	From randomization up to the end of treatment plus 4 weeks
Cost-effectiveness analysis	assessed by Quality-Adjusted Live Years (QALYs), incremental cost-effectiveness ratio (ICER)	At time of completion of 5-year surveillance period
Health-related quality of life (EORTC-QLQ-C30)	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.	Over the 5 year surveillance period
Health-related quality of life (EORTC-QLQ-OV28)	The EORTC QLQ-OV28 is a specified questionnaire for patients with ovarian cancer. Participant responses to the question are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized so that scores range from 0 to 100. A lower score indicates a better outcome.	Over the 5 year surveillance period
Health-related quality of life (EQ-5D-5L)	Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5).	Over the 5 year surveillance period

Collaborators and Investigators

• Sponsor: National Cancer Center, Korea

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: April 12, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Ovarian cancer; Hyperthermic intraperitoneal chemotherapy; HIPEC; Neoadjuvant chemotherapy; FOCUS; Epithelial ovarian cancer; Carcinoma, Ovarian Epithelial; Interval cytoreductive surgery; kov-hipec-04; kov-04
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Genital Diseases, Female; Endocrine Gland Neoplasms; Neoplasms, Glandular and Epithelial; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Carcinoma; Carcinoma, Ovarian Epithelial; Ovarian Neoplasms; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Platinum Compounds; Cisplatin
• Other Study ID Numbers: NCC2023-0100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes