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NOT YET RECRUITING
NCT07295132
PHASE2

RESCUE Study (REcurrent Ovarian Cancer Secondary Cytoreduction Using Chemotherapy rEsponse)

Sponsor: Asan Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized Clinical Trial Evaluating the Role of Secondary Cytoreductive Surgery Following Neoadjuvant Chemotherapy in Platinum-Sensitive Recurrent Ovarian Cancer: Patient Selection Informed by CA-125 Response Dynamics During Chemotherapy (RESCUE Study)

Key Details

Gender

FEMALE

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2025-12-15

Completion Date

2029-11-15

Last Updated

2025-12-19

Healthy Volunteers

No

Interventions

PROCEDURE

Secondary cytoreductive surgery

Secondary Cytoreductive Surgery (SCS) is a surgical procedure performed on patients with relapsed or recurrent epithelial ovarian cancer, after they have completed their initial course of treatment (such as primary surgery and chemotherapy).

DRUG

Platinum Based Chemotherapy

Platinum Based Chemotherapy