Actively Recruiting
Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance
Led by Korea University Guro Hospital · Updated on 2025-03-06
124
Participants Needed
1
Research Sites
264 weeks
Total Duration
On this page
Sponsors
K
Korea University Guro Hospital
Lead Sponsor
B
Boryung Pharmaceutical Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 maintenance
- Women aged 5 18 years
- Complete resection of the tumor seems possible (estimated by an experienced surgeon)
- Intra-abdominal disease excluded by MRI/CT if isolated extra-abdominal recurrences are planned
- Positive AGO-score or iMODEL+PET/CT OR likely complete resection by surgeon and radiologist consensus
- Signed informed consent and consent to data transmission and processing
You will not qualify if you...
- Patients with non-epithelial tumors or borderline tumors
- Patients without recurrence scheduled for diagnostic/second-look or debulking surgery after chemotherapy
- More than one prior chemotherapy
- Patients with second, third, or later recurrence
- Patients with second malignancies treated by laparotomy or other neoplasms interfering with treatment or prognosis
- Platinum-refractory tumor (progression during chemotherapy or recurrence within 6 months of prior platinum therapy)
- Only palliative surgery planned
- Radiological signs of metastases inaccessible to surgery
- Concomitant disease preventing surgery or chemotherapy
- Medical history with excessive peri-operative risk
- Current medication causing significant surgical risk (e.g., oral anticoagulants, bevacizumab)
- No assessable archival tumor tissue
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Severance Hospital
Seoul, South Korea
Actively Recruiting
Research Team
H
Hyun-Woong Cho, MD. PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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