NCT05704621RecruitingPhase 2
Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance
A Randomized Phase II Study of Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance
Source: ClinicalTrials.gov · Last updated 6 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- First submitted
- 19 Jan 2023
- Start date
- 1 Dec 2023
- Primary completion date
- 28 Dec 2026
- Lead sponsor
- Korea University Guro Hospital
- Diseases
- Ovarian cancer
- NCT number
- NCT05704621
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 124
- From 1 Dec 2023 to the primary completion date, 28 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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
Other illness
- 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.
- Any current medication inducing considerable surgical risk (e.g. bleeding: due to oral anticoagulating agents, bevacizumab)
Other
- Patients with non-epithelial tumors as well as borderline tumors.
- Patients with second, third, or later recurrence
- Any medical history indicating excessive peri-operative risk
- No assessable archival tumor tissue
Who the study is looking for
- 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
- A positive AGO-score or iMODEL+PET/CT
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.