NCT05827523

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P50-P75 for phase_3 ovarian-cancer

Timeline
56mo left

Started May 2023

Typical duration for phase_3 ovarian-cancer

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
May 2023Dec 2030

First Submitted

Initial submission to the registry

April 12, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 31, 2023

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

February 13, 2026

Status Verified

June 1, 2025

Enrollment Period

4.6 years

First QC Date

April 12, 2023

Last Update Submit

February 11, 2026

Conditions

Ovarian Cancer

Keywords

Ovarian cancerHyperthermic intraperitoneal chemotherapyHIPECInterval cytoreductive surgeryNeoadjuvant chemotherapyCarcinoma, Ovarian EpithelialEpithelial ovarian cancerFOCUSkov-hipec-04kov-04

Outcome Measures

Primary Outcomes (1)

  • Overall survival (OS)

    From randomization to the date of death from any cause, assessed up to 5 years

Secondary Outcomes (8)

  • 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)

    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

    From randomization up to the end of treatment plus 4 weeks

  • Health-related quality of life (EORTC-QLQ-C30)

    Over the 5 year surveillance period

  • +3 more secondary outcomes

Study Arms (2)

HIPEC

EXPERIMENTAL

Interval cytoreductive surgery with HIPEC

Drug: Cisplatin

No HIPEC

NO INTERVENTION

Interval cytoreductive surgery without HIPEC

Interventions

CisplatinDRUG

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

HIPEC

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML,
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Chungnam National University Hospital

Sejong, Chungcheongnam-do, South Korea

NOT YET RECRUITING

Chungnam National University Sejong Hospital

Sejong, Chungcheongnam-do, South Korea

NOT YET RECRUITING

Ilsan CHA University Hospital

Goyang-si, Gyeonggi-do, South Korea

RECRUITING

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

RECRUITING

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

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

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Central Study Contacts

Myong Cheol Lim, MD, Ph.D

CONTACT

+820319201760gynlim@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Enrolled patients are unaware of which group they have been assigned to.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled, single-blinded, multicenter phase III trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Researcher

Study Record Dates

First Submitted

April 12, 2023

First Posted

April 25, 2023

Study Start

May 31, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2030

Last Updated

February 13, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(10)