Surgery with or without heated chemotherapy for advanced ovarian cancer
Phase III Randomized Trial of HIPEC in Primary Stage Three & Four Primary Ovarian Cancer After Interval Cytoreductive Surgery (FOCUS, KOV-04)
This study is testing if adding heated chemotherapy during surgery can help people with advanced ovarian cancer do better than just having surgery alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 520 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | National Cancer Center, Korea Government |
| Drugs / interventions | chemotherapy |
| Locations | 10 sites (Sejong, Chungcheongnam-do and 9 other locations) |
| Trial ID | NCT05827523 on ClinicalTrials.gov |
What this trial studies
This phase III randomized controlled trial aims to evaluate the effectiveness of hyperthermic intraperitoneal chemotherapy (HIPEC) using cisplatin during interval cytoreductive surgery in patients with stage III-IV primary epithelial ovarian cancer. Participants will be randomly assigned to receive either HIPEC or no HIPEC following neoadjuvant chemotherapy. The study seeks to determine if the addition of HIPEC improves clinical outcomes compared to standard surgical treatment alone. The trial will include patients who have undergone three cycles of neoadjuvant chemotherapy and meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 79 with stage III-IV primary epithelial ovarian cancer who have received neoadjuvant chemotherapy.
Not a fit: Patients with non-epithelial ovarian cancers or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment outcomes for patients with advanced ovarian cancer.
How similar studies have performed: Previous studies have shown promising results with HIPEC in various cancers, suggesting potential benefits in this context, although this specific approach is being tested in a novel setting.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Sejong, Chungcheongnam-do and 9 other locations
- 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)
Study contacts
- Study coordinator: Myong Cheol Lim, MD, Ph.D
- Email: gynlim@gmail.com
- Phone: +820319201760
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.