Heated chemo during surgery may extend life for Drug-Resistant ovarian cancer
NCT ID NCT05316181
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a combination of surgery to remove visible tumors plus heated chemotherapy delivered directly into the abdomen can help people with ovarian cancer that has stopped responding to standard platinum-based chemo. About 140 adults with this type of recurrent ovarian cancer will be randomly assigned to receive either surgery plus heated chemo or standard care alone. The main goal is to see if the combination delays cancer growth and improves survival.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2022
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ewha Womans University Mokdong Hospital
Seoul, South Korea
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Korea University Anam hospital
Seoul, South Korea
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Myong Cheol Lim
Goyang-si, Gyeonggi-do, 10408, South Korea
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Other studies related to the condition(s) this trial covers.
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