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NCT05704621
Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance
Conditions: Ovarian Cancer, Drug Related Neoplasm/Cancer
Sex: Female
Ages: 18 Years – N/A
Phase: PHASE2
Enrollment: 124
Sponsor: Korea University Guro Hospital
Summary
This is a randomized phase II study of secondary cytoreductive surgery (CRS) in patients with relapsed ovarian cancer who have progressed on PARP inhibitor maintenance.
Eligibility Criteria
Inclusion Criteria:Patients with first recurrence of platinum sensitive, invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage.Progression-free interval of at least 6 months after end of last platinum- containing therapy,Progressed during PARP inhibitor maintenanceWomen aged ≥ 18 yearsComplete resection of the tumor by median laparotomy seems possible (estimated by an experienced surgeon).
Intra-abdominal disease has to be excluded by MRI/CT, if other surgical approaches for isolated extra-abdominal recurrences are plannedA positive AGO-score or iMODEL+PET/CTPatients who are likely to be completely resected according to the investigator's judgment will be allowed by consensus between PI(surgeon) and designated radiologist even if AGO or iMODEL+PET/CT negative.Patients who have given their signed and written informed consent and their consent to data transmission and -processing.Exclusion Criteria:Patients with non-epithelial tumors as well as borderline tumors.Patients without recurrence who are scheduled for diagnostic/second-look surgery or debulking surgery after completion of chemotherapyMore than one prior chemotherapyPatients who are ineligible for pegylated liposomal doxorubicin or carboplatinPatients with second, third, or later recurrencePatients with second malignancies who have been treated by laparotomy, as well as other neoplasms, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected.Patients with so-called platinum-refractory tumor, i.e. progression during chemotherapy or recurrence within 6 months after end of former first platinum- containing therapyOnly palliative surgery plannedRadiological signs suggesting metastases not accessible to surgical removal (i.e.
complete resection is deemed impossible)Any concomitant disease not allowing surgery and/or chemotherapyAny medical history indicating excessive peri-operative riskAny current medication inducing considerable surgical risk (e.g.
bleeding: due to oral anticoagulating agents, bevacizumab)No assessable archival tumor tissue
Source: ClinicalTrials.gov (NCT05704621). StuddyBuddy aggregates publicly available trial information.