Surgery with or without heated chemotherapy for advanced ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Severance Hospital
  Seoul, South Korea Recruiting
• 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

Study contacts

• Study coordinator: Myong Cheol Lim, MD, Ph.D
• Email: gynlim@gmail.com
• Phone: +820319201760

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.