CRS & HIPEC for Platinum-Resistant Recurrent Ovarian Cancer (KOV-02R, RECOVER)
NCT ID: NCT05316181
Last Updated: 2025-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
140 participants
INTERVENTIONAL
2022-04-07
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cytoreductive surgery and HIPEC
Cytoreductive surgery + Hyperthermic Intraperitoneal Chemotherapy (HIPEC) followed by physician-choice chemotherapy until disease progression.
HIPEC
HIPEC perfusion, doxorubicin 35mg/m2 \& mitomycin 15 mg/m2, 41.5'C, 90 min.
No HIPEC
Physician-choice chemotherapy from enrollment until disease progression.
No interventions assigned to this group
Interventions
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HIPEC
HIPEC perfusion, doxorubicin 35mg/m2 \& mitomycin 15 mg/m2, 41.5'C, 90 min.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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National Cancer Center, Korea
OTHER_GOV
Responsible Party
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Myong Cheol Lim
Principal investigator
Locations
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Myong Cheol Lim
Goyang-si, Gyeonggi-do, South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Korea University Anam hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Kim JH, Park E, Park SY, Lim MC. A randomized, multicenter, open-label phase III trial of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in platinum-resistant recurrent ovarian cancer: a rationale and study design of the KOV-HIPEC-02 trial. Int J Gynecol Cancer. 2025 Apr;35(4):101630. doi: 10.1016/j.ijgc.2025.101630. Epub 2025 Jan 9.
Other Identifiers
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NCC2021-0334
Identifier Type: -
Identifier Source: org_study_id
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