Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
NCT05827523

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

Led by National Cancer Center, Korea · Updated on 2026-02-13

520

Participants Needed

10

Research Sites

395 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and written informed consent
  • Age 18 to under 80 years
  • Histologically confirmed FIGO stage III-IV primary epithelial ovarian, fallopian tube, or primary peritoneal cancer
  • Treated with three cycles of neoadjuvant chemotherapy
  • Underwent interval complete cytoreduction or cytoreduction with residual disease no deeper than 2.5 mm
  • Life expectancy greater than 3 months as judged clinically
  • Adequate organ function for surgery and HIPEC
  • Women medically unable to conceive or of childbearing potential agree to contraceptive guidelines during treatment
  • Consent to provide clinical information for secondary use if desired
Not Eligible

You will not qualify if you...

  • Diagnosis of non-epithelial ovarian carcinoma or borderline ovarian tumor
  • No neoadjuvant chemotherapy received
  • Interval cytoreduction with residual disease deeper than 2.5 mm
  • Life expectancy 3 months or less as judged clinically
  • History of previous malignancy within 5 years affecting treatment results, except certain skin cancers and early endometrial carcinoma
  • Presence of myelodysplastic syndrome or acute myeloid leukemia
  • Active central nervous system metastasis or unstable brain metastases
  • Active infections requiring systemic antibiotic treatment
  • Uncontrolled active tuberculosis
  • Psychiatric or substance abuse disorders interfering with trial participation
  • Hypersensitivity or contraindications to cisplatin
  • History of allogeneic tissue or organ transplantation or double umbilical cord transplantation
  • Any condition or therapy that may interfere with study results or participation as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

Chungnam National University Hospital

Sejong, Chungcheongnam-do, South Korea

Not Yet Recruiting

2

Chungnam National University Sejong Hospital

Sejong, Chungcheongnam-do, South Korea

Not Yet Recruiting

3

Ilsan CHA University Hospital

Goyang-si, Gyeonggi-do, South Korea

Actively Recruiting

4

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Actively Recruiting

5

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Actively Recruiting

6

Pusan National University Hospital

Pusan, South Korea

Not Yet Recruiting

7

Pusan National University Yangsan Hospital

Pusan, South Korea

Not Yet Recruiting

8

Asan Medical Center

Seoul, South Korea

Not Yet Recruiting

9

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Not Yet Recruiting

10

Severance Hospital

Seoul, South Korea

Actively Recruiting

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Research Team

M

Myong Cheol Lim, MD, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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