To compare outcomes between the CRS group and the control group in patients with recurrent epithelial ovarian cancer who have undergone chemotherapy
\[Primary Objective\] 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
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.
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, South Korea
RECRUITINGProgression free survival (PFS)
From randomization to time of first progression or death
Time frame: From randomization to the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 5 years
Overall survival
From randomization to death.
Time frame: From randomization to the date of death from any cause, assessed up to 5 years
Cancer specific survival
Cancer specific survival: From randomization to death from ovarian cancer
Time frame: From date of randomization until the date of death due to ovarian cancer, assessed up to 5 years
Adverse Event
Time frame: 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-C30)
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.
Time frame: Over the 5 year surveillance period
Health-related quality of life (EORTC-QLQ-OV28)
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.
Time frame: Over the 5 year surveillance period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Health-related quality of life (EQ-5D-5L)
Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5).
Time frame: Over the 5 year surveillance period
CA-125 KELIM Model
Time frame: Over the 5 year surveillance period
Economic and cost evaluation
Time frame: At the time of completion of 5-year surveilance period