Secondary Cytoreductive Surgery After Chemotherapy for Recurrent Epithelial Ovarian Cancer
ConditionOvarian Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age19-80
SponsorNational Cancer Center, Korea
About this trial
To compare outcomes between the CRS group and the control group in patients with recurrent epithelial ovarian cancer who have undergone chemotherapy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
Patients with recurrent ovarian cancer who have received platinum-based chemotherapy (3 or 4 cycles) and were deemed unsuitable for secondary cytoreductive surgery due to a negative AGO score according to the DESKTOP-III trial.
Patients with recurrent ovarian cancer who have responded to chemotherapy (Complete Response, Partial Response, or Stable Disease).
The patient's disease must have recurred after platinum-based therapy, and be defined as platinum-sensitive, meaning progression occurred more than 6 months (180 days) after the last administration of platinum-based therapy.
Disqualifiers
Patients with non-epithelial ovarian cancer or borderline ovarian tumors.
Patients with recurrent ovarian cancer who are not suitable for platinum-based chemotherapy.
Patients over 80 years of age.
Patients with a clinically assessed life expectancy of less than 3 months.
Trial design
Design model
Parallel
Treatments tested in this trial
Secondary Cytoreductive Surgery
Procedure/SurgerySurgery 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: No-Secondary Cytoreductive SurgeryNo intervention 0 interventions
Group B: Secondary Cytoreductive SurgeryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression 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 yearsSecondary outcomes
1
Overall survival
From randomization to death.
Time frame
From randomization to the date of death from any cause, assessed up to 5 years2
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 years3
Adverse Event
Time frame
1 day after surgery, recovery period (3-5 weeks after surgery), up to 6 weeks after completion of chemotherapy4
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 periodSponsors and contacts
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Source ClinicalTrials.gov