Secondary Cytoreductive Surgery After Chemotherapy for Recurrent Epithelial Ovarian Cancer

Not Applicable

Recruiting

• Conditions: Ovarian Cancer

• Registration Number: NCT07171528
• Lead Sponsor: National Cancer Center, Korea

Brief 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.

Study Timeline

• Study First Submitted: 2025-08-19
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-08
• Last Update Submitted: 2025-09-08
• Study Start: 2025-09-10
• Study First Posted: 2025-09-12
• Last Update Posted: 2025-09-12
• Primary Completion: 2027-12-31
• Study Completion: 2033-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	From randomization to the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 5 years	From randomization to time of first progression or death

Secondary Outcome Measures

Name	Time	Method
Overall survival	From randomization to the date of death from any cause, assessed up to 5 years	From randomization to death.
Cancer specific survival	From date of randomization until the date of death due to ovarian cancer, assessed up to 5 years	Cancer specific survival: From randomization to death from ovarian cancer
Adverse Event	1 day after surgery, recovery period (3-5 weeks after surgery), up to 6 weeks after completion of chemotherapy
Health-related quality of life (EORTC-QLQ-OV28)	Over the 5 year surveillance period	The EORTC QLQ-OV28 is a specified questionnaire for patients with ovarian cancer. Participant responses to the question are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized so that scores range from 0 to 100. A lower score indicates a better outcome.
Health-related quality of life (EQ-5D-5L)	Over the 5 year surveillance period	Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5).
CA-125 KELIM Model	Over the 5 year surveillance period
Economic and cost evaluation	At the time of completion of 5-year surveilance period
Health-related quality of life (EORTC-QLQ-C30)	Over the 5 year surveillance period	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.

Trial Locations

Locations (1)

National Cancer Center, Korea; 🇰🇷 Goyang-si, Gyeonggi-do, South Korea