NCT05704621 Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance
| NCT ID | NCT05704621 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Korea University Guro Hospital |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 124 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2026-12-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 124 participants in total. It began in 2023-12-01 with a primary completion date of 2026-12-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 maintenance * Women aged ≥ 18 years * Complete resection of the tumor 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 planned 1. A positive AGO-score or iMODEL+PET/CT 2. Patients 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 chemotherapy * More than one prior chemotherapy * Patients with second, third, or later recurrence * Patients 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 therapy * Only palliative surgery planned * Radiological signs suggesting metastases not accessible to surgical removal (i.e. complete resection is deemed impossible) * Any concomitant disease not allowing surgery and/or chemotherapy * Any medical history indicating excessive peri-operative risk * Any current medication inducing considerable surgical risk (e.g. bleeding: due to oral anticoagulating agents, bevacizumab) * No assessable archival tumor tissue
Contact & Investigator
Hyun-Woong Cho, MD. PhD.
PRINCIPAL INVESTIGATOR
Korea University Guro Hospital
Frequently Asked Questions
Who can join the NCT05704621 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05704621 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05704621 currently recruiting?
Yes, NCT05704621 is actively recruiting participants. Contact the research team at limpcho82@gmail.com for enrollment information.
Where is the NCT05704621 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05704621 clinical trial?
NCT05704621 is sponsored by Korea University Guro Hospital. The principal investigator is Hyun-Woong Cho, MD. PhD. at Korea University Guro Hospital. The trial plans to enroll 124 participants.
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