CRS & HIPEC for Platinum-Resistant Recurrent Ovarian Cancer (KOV-02R, RECOVER) (NCT05316181) | Clinical Trial Compass
Active — Not RecruitingPhase 3
CRS & HIPEC for Platinum-Resistant Recurrent Ovarian Cancer (KOV-02R, RECOVER)
South Korea140 participantsStarted 2022-04-07
Plain-language summary
Platinum-resistant recurrent epithelial ovarian cancer randomizing with or without cytoreductive surgery + hyperthermic intraperitoneal chemotherapy (HIPEC): KOV-02R, RECOVER
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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…
What they're measuring
1
Progression-free survival (PFS)
Timeframe: From randomization to time of first progression or death from any cause, whichever came first, assessed up to 5 years