None listed
Conditions
Interventions
Procedure/Surgery : secondary cytoreduction
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Female patients aged 19 years or older with first recurrence of platinum-sensitive, invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer, regardless of initial stage A progression-free interval (PFI) of at least 6 months after completion of the last platinum-based chemotherapy Demonstrated response to preoperative chemotherapy after recurrence, defined as: Complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1, or A GCIG CA-125 response, defined as a =50% reduction in pre-treatment CA-125 levels maintained for at least 28 days Patients for whom complete cytoreduction is deemed feasible based on expert surgical assessment, including: Positive AGO score and/or positive iMODEL + PET/CT, or Investigator-assessed operable disease with localized peritoneal recurrence (regional recurrence involving =3 regions or limited carcinomatosis) Patients who have provided written informed consent, including consent for data collection and processing
Exclusion criteria
Exclusion criteria: Patients without disease recurrence Patients with non-epithelial tumors or borderline tumors Patients who received more than one line of chemotherapy prior to study enrollment Patients with second or later recurrence (i.e., second, third, or subsequent relapse) Patients with a history of laparotomy or secondary malignancies whose treatment may interfere with the management of recurrent ovarian cancer or significantly impact prognosis Patients with platinum-refractory disease, defined as disease progression during chemotherapy or recurrence within 6 months after completion of the first platinum-based regimen Patients who are only candidates for palliative surgery Patients with radiologic evidence of unresectable disease, indicating that complete cytoreduction is not feasible Patients with any comorbid condition that would preclude surgery and/or chemotherapy (e.g., poor general condition, infection, conditions associated with severe bleeding, significant renal impairment) Patients with a medical history that would pose excessive perioperative risk (e.g., poor general condition, infection, conditions associated with severe bleeding, significant renal impairment) Patients taking medications that may significantly increase surgical risk, such as oral anticoagulants or those at risk of bleeding due to bevacizumab Patients without accessible or stored tumor tissue suitable for molecular evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | — |
Countries
Korea, Republic of
Contacts
Public ContactDae Yeon Kim
Asan Medical Center
Outcome results
None listed