NCT07171528

Secondary Cytoreductive Surgery After Chemotherapy for Recurrent Epithelial Ovarian Cancer

Secondary Cytoreductive Surgery After Chemotherapy for Recurrent Epithelial Ovarian Cancer: A Phase II Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: Female
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To compare outcomes between the CRS group and the control group in patients with recurrent epithelial ovarian cancer who have undergone chemotherapy

Detailed description

\[Primary Objective\] To compare the progression-free survival (PFS) between the CRS group and the control group in patients with recurrent epithelial ovarian cancer who have undergone chemotherapy. \[Secondary Objectives\] 1. To compare the overall survival (OS) and cancer-specific survival (CSS) between the CRS group and the control group in patients with recurrent epithelial ovarian cancer who have undergone chemotherapy. 2. To evaluate the adverse events between the CRS group and the control group in patients with recurrent epithelial ovarian cancer who have undergone chemotherapy. 3. To assess the quality of life (QoL) between the CRS group and the control group in patients with recurrent epithelial ovarian cancer who have undergone chemotherapy. 4. To investigate the prognostic role of the CA-125 KELIM model in patients with recurrent epithelial ovarian cancer who have undergone chemotherapy. 5. To perform a cost-effectiveness analysis of the CRS group in patients with recurrent epithelial ovarian cancer who have undergone chemotherapy.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
PROCEDURE	Secondary Cytoreductive Surgery	Surgery will only be performed in patients assigned to the experimental arm of the study. The goal of secondary cytoreductive surgery is to achieve complete tumor reduction by removing all visible residual tumors (Complete cytoreduction with no macroscopic residual disease), and this effort should be the top priority.

Timeline

• Start date: 2025-09-10
• Primary completion: 2027-12-31
• Completion: 2033-12-31
• First posted: 2025-09-12
• Last updated: 2025-09-12

Locations

1 site across 1 country: South Korea