RecruitingPhase 2

Secondary Cytoreductive Surgery After Chemotherapy for Recurrent Epithelial Ovarian Cancer

South Korea80 participantsStarted 2025-09-10

Plain-language summary

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

Who can participate

Age range19 Years – 80 Years

SexFEMALE

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Inclusion criteria

✓. 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.
✓. Patients aged 19 years or older at the time of providing informed written consent.
✓. Patients with an ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2 within 28 days prior to clinical trial allocation.
✓. Women who are medically unable to conceive or, if of childbearing potential, must agree to follow contraception guidelines during the treatment period.
✓. The participant (or their legally authorized representative) must provide informed written consent regarding the trial.

Exclusion criteria

✕. 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.
✕. Patients deemed unsuitable for secondary cytoreductive surgery due to clinical findings (e.g., severe adhesions, bowel obstruction, fistula, perforation, or other conditions making surgery infeasible).
✕. Patients with inadequate, cardiac, pulmonary, hepatic, renal, or bone marrow function for surgery.
✕. Patients with uncontrolled active infections.
✕. Patients diagnosed with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), or those exhibiting features suggestive of MDS/AML.

What they're measuring

Progression free survival (PFS)

Timeframe: From randomization to the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 5 years

Trial details

NCT IDNCT07171528

SponsorNational Cancer Center, Korea

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2027-12-31

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