About this trial
This is a multicenter, prospective, randomized, open-label Phase III clinical trial (RESCUE study) evaluating the efficacy of secondary cytoreductive surgery (SCS) in patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have shown a favorable response to 3-4 cycles of platinum-based neoadjuvant chemotherapy and are assessed as highly likely to achieve complete tumor resection based on selection models. Eligible patients will be randomly assigned to either the experimental arm, receiving SCS followed by chemotherapy (with or without maintenance), or the active comparator arm, receiving chemotherapy only (with or without maintenance), with the primary objective being to compare the Progression-Free Survival (PFS) between the two groups to determine the additional clinical benefit of SCS in this carefully selected patient population.
Eligibility criteria
Qualifiers
First recurrence of platinum-sensitive, invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer, regardless of initial stage.
A progression-free interval of at least 6 months after the end of the last platinum-containing regimen.
Demonstrated response during neoadjuvant chemotherapy after recurrence (Complete Response/Partial Response/Stable Disease according to RECIST 1.1 or GCIG CA-125 response, which is a ≥50% reduction in pre-treatment CA-125 level sustained for ≥28 days).
Women aged 19 years or older.
Disqualifiers
Patients without recurrence
Patients with non-epithelial tumors or borderline tumors.
Patients with second, third, or subsequent recurrence.
Patients with a secondary malignancy treated with laparotomy and other neoplasms, where the treatment is expected to interfere with the treatment of recurrent ovarian cancer or significantly affect prognosis.
Trial design
Treatments tested in this trial
- Secondary cytoreductive surgery
- Platinum Based Chemotherapy
Treatment groups
Locations
Sponsors and collaborators
Asan Medical Center
Lead sponsor
Korean Gynecologic Oncology Group
Collaborator