Treatment for platinum-resistant recurrent ovarian cancer using HIPEC
Randomized Phase III Trial of Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Platinum-Resistant Recurrent Ovarian Cancer: KOV-02R - Resistant Cancer of Ovary (RECOVER)
This study is testing if a special heated chemotherapy treatment combined with surgery can help people with hard-to-treat ovarian cancer live longer compared to standard chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | National Cancer Center, Korea Government |
| Drugs / interventions | chemotherapy, doxorubicin |
| Locations | 3 sites (Goyang-si, Gyeonggi-do and 2 other locations) |
| Trial ID | NCT05316181 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the survival benefits of hyperthermic intraperitoneal chemotherapy (HIPEC) combined with cytoreductive surgery compared to standard physician-choice chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer. Participants will be randomized to receive either the experimental treatment or the control. The study focuses on patients with resectable intraperitoneal disease and aims to provide evidence for a potentially more effective treatment approach. The trial is designed to assess the efficacy of HIPEC with doxorubicin and mitomycin in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with histologically confirmed platinum-resistant recurrent epithelial ovarian cancer who have resectable disease.
Not a fit: Patients with non-resectable disease or those who are not platinum-resistant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates for patients with platinum-resistant recurrent ovarian cancer.
How similar studies have performed: Previous studies have shown promising results with HIPEC in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
* Inclusion Criteria: * Patients ≥18 years old, * Patients with Eastern Cooperative Oncology Group (ECOG) Performance status 0-2, * Patients diagnosed with histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, * Resistant to platinum-based chemotherapy (Platinum-refractory or resistant disease) * Resectable intraperitoneal disease based on previous clinical history and recent image finding, * A life expectancy \> 3 months as clinically judged, * Women who are medically unable to conceive or who are of childbearing potential, agree to follow contraceptive guidelines during treatment, * Patient 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 and, * Adequate organ function for cytoreductive surgery and HIPEC * Exclusion criteria: * Non-epithelial ovarian carcinoma, * Borderline ovarian tumor, * Patients who are not appropriate for surgical and HIPEC procedures based on previous surgery or clinical findings, including severe intestinal adhesions, obstruction, or abdominal fistula, * Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML, * Patients which extra-abdominal disease is a major disease or is expected to cause of death, * 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, * Patient diagnosed with a psychiatric disorder or substance abuse disorder that would interfere with your ability to cooperate with the trial, * Patients who have not undergone hysterectomy and have a positive urine pregnancy test result within 14 days prior to clinical trial assignment, even if the urine pregnancy test result is negative at screening, * Pregnant or lactating women, * Patients with any contraindications to the use of doxorubicin or mitomycin (i.e., hypersensitivity to doxorubicin or mitomycin), * 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, interfere with the patient's participation, in the opinion of the treating investigator.
Where this trial is running
Goyang-si, Gyeonggi-do and 2 other locations
- Myong Cheol Lim — Goyang-si, Gyeonggi-do, Korea, Republic of (Recruiting)
- Ewha Womans University Mokdong Hospital — Seoul, Korea, Republic of (Recruiting)
- Korea University Anam hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Myong Cheol Lim, MD, Ph.D
- Email: mclim@ncc.re.kr
- 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.