Surgery for patients with relapsed ovarian cancer after PARP inhibitor treatment
A Randomized Phase II Study of Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance
PHASE2 · Korea University Guro Hospital · NCT05704621
This study is testing if a second surgery can help women with relapsed ovarian cancer who didn't respond to PARP inhibitors feel better and live longer.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Korea University Guro Hospital (other) |
| Drugs / interventions | bevacizumab, chemotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05704621 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial investigates the effectiveness of secondary cytoreductive surgery (CRS) in patients with relapsed ovarian cancer who have shown progression during PARP inhibitor maintenance therapy. The study aims to determine if CRS can provide clinical benefits for these patients, particularly those who are considered to have a complete resection of their tumors. Participants will undergo surgery and may also receive chemotherapy as part of their treatment plan. The trial is randomized, allowing for a comparison of outcomes between different treatment approaches.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with first recurrence of platinum-sensitive invasive epithelial ovarian cancer who have progressed during PARP inhibitor maintenance.
Not a fit: Patients with non-epithelial tumors or those who are not candidates for complete tumor resection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new surgical option that improves outcomes for patients with relapsed ovarian cancer who have become resistant to PARP inhibitors.
How similar studies have performed: Other studies have explored surgical interventions in similar contexts, but this specific approach in the setting of PARP inhibitor resistance is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Severance Hospital — Seoul, South Korea (RECRUITING)
Study contacts
- Principal investigator: Hyun-Woong Cho, MD. PhD. — Korea University Guro Hospital
- Study coordinator: Hyun-Woong Cho, MD. PhD.
- Email: limpcho82@gmail.com
- Phone: 82-2-2626-3228
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ovarian Cancer, Drug Related Neoplasm/Cancer, recurrent ovarian cancer, PARP inhibitor resistance, secondary cytoreductive surgery, progression during PARP inhibitor maintenance