Ovarian CancerPhase 3FOCUS / KOV-04NCT05827523
Interval Cytoreductive Surgery With or Without HIPEC for Ovarian Cancer (FOCUS / KOV-HIPEC-04)
A Phase 3 study testing Cisplatin in people with Ovarian Cancer, run by National Cancer Center, Korea at 10 sites in South Korea.
Trial summary
Primary stage III-IV epithelial ovarian cancer randomizing between interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 31 May 2023to 31 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diagnosed with non-epithelial ovarian carcinoma or borderline ovarian tumor
- Patients who have not undergone neoadjuvant chemotherapy,
- Interval cytoreduction with more than 2.5 mm depth of residual disease,
- A life expectancy ≤3 months as clinically judged,
- 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,
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- 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,
- 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,
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
South Korea10 sites, 10 recruiting
- Recruiting
Ilsan CHA University Hospital
Goyang-si, Gyeonggi-do
- Recruiting
National Cancer Center
Goyang-si, Gyeonggi-do
Myong Cheol Lim, MD, PhD, +820319201760, gynlim@gmail.com
Ji Hyun Kim, MD, gynlittle@gmail.com
- Not yet recruiting
Pusan National University Hospital
Pusan
- Not yet recruiting
Pusan National University Yangsan Hospital
Pusan
- Not yet recruiting
Chungnam National University Hospital
Sejong, Chungcheongnam-do
- Not yet recruiting
Chungnam National University Sejong Hospital
Sejong, Chungcheongnam-do
- Not yet recruiting
Asan Medical Center
Seoul
- Not yet recruiting
Ewha Womans University Mokdong Hospital
Seoul
- Recruiting
Severance Hospital
Seoul
- Recruiting
Ajou University Hospital
Suwon, Gyeonggi-do
About this study
Official title: 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)
Read the 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.
- Conditions
- Ovarian Cancer
- Being tested
- Cisplatin
- Keywords
- Ovarian cancer, Hyperthermic intraperitoneal chemotherapy, HIPEC, Interval cytoreductive surgery, Neoadjuvant chemotherapy, Carcinoma, Ovarian Epithelial, Epithelial ovarian cancer, FOCUS, kov-hipec-04, kov-04
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin 75mg/m2 after interval cytoreductive surgery
| Study group | Role | What they receive |
|---|---|---|
| HIPEC | Experimental | Interval cytoreductive surgery with HIPEC Receives: Drug: Cisplatin |
| No HIPEC | No intervention | Interval cytoreductive surgery without HIPEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Measured: From randomization to the date of death from any cause, assessed up to 5 years
Secondary outcomes (8)
Progression-free survival (PFS)
Measured: From randomization to time of first progression or death from any cause, whichever came first, assessed up to 5 years
Cancer-specific survival
Measured: 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
Measured: 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
Measured: From randomization up to the end of treatment plus 4 weeks
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.
Measured: 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.
Measured: 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).
Measured: Over the 5 year surveillance period
Cost-effectiveness analysis
assessed by Quality-Adjusted Live Years (QALYs), incremental cost-effectiveness ratio (ICER)
Measured: At time of completion of 5-year surveillance period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start31 May 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled, single-blinded, multicenter phase III trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Myong Cheol Lim, MD, PhD, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827523
- Sponsor's protocol ID
- NCC2023-0100
- Acronym
- FOCUS / KOV-04
- Status last verified
- Jun 2025
- First submitted
- 12 Apr 2023
- Last updated
- 13 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Trial of HIPEC in Primary Stage Three & Four Primary Ovarian Cancer After Interval Cytoreductive Surgery (FOCUS, KOV-04)
- ClinicalTrials.gov ID
- NCT05827523
- Acronym / sponsor ID
- FOCUS / KOV-04 / NCC2023-0100
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian cancer, Hyperthermic intraperitoneal chemotherapy, HIPEC, Interval cytoreductive surgery, Neoadjuvant chemotherapy, Carcinoma, Ovarian Epithelial, Epithelial ovarian cancer, FOCUS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 31 May 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled, single-blinded, multicenter phase III trial
| Arm | Type | Receives |
|---|---|---|
| HIPEC | Experimental | Drug: CisplatinInterval cytoreductive surgery with HIPEC |
| No HIPEC | No intervention | –Interval cytoreductive surgery without HIPEC |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (13 listed)
- Diagnosed with non-epithelial ovarian carcinoma or borderline ovarian tumor
- Patients who have not undergone neoadjuvant chemotherapy,
- Interval cytoreduction with more than 2.5 mm depth of residual disease,
- A life expectancy ≤3 months as clinically judged,
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CisplatinHyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin 75mg/m2 after interval cytoreductive surgery | Drug | HIPEC |
Primary outcome
Overall survival (OS)
Time frame: From randomization to the date of death from any cause, assessed up to 5 years
8 secondary outcomes
Progression-free survival (PFS)
Time frame: From randomization to time of first progression or death from any cause, whichever came first, assessed up to 5 years
Cancer-specific survival
Time frame: From randomization to the date of death due to ovarian cancer, assessed up to 5 years
Time to first subsequent therapy (TFST)
Time frame: 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
Time frame: From randomization up to the end of treatment plus 4 weeks
Health-related quality of life (EORTC-QLQ-C30)
Time frame: Over the 5 year surveillance period
Health-related quality of life (EORTC-QLQ-OV28)
Time frame: Over the 5 year surveillance period
Health-related quality of life (EQ-5D-5L)
Time frame: Over the 5 year surveillance period
Cost-effectiveness analysis
Time frame: At time of completion of 5-year surveillance period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cisplatin in people with Ovarian Cancer, run by National Cancer Center, Korea at 10 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Myong Cheol Lim, MD, Ph.D (+820319201760, gynlim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: From randomization to the date of death from any cause, assessed up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.