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

December 16, 2025 updated by: Dae-Yeon Kim, Asan Medical Center

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)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The RESCUE study is a major clinical trial focused on improving treatment for women battling recurrent ovarian, fallopian tube, or primary peritoneal cancer. These cancers, which often return after initial treatment, are known to be aggressive. The challenge for doctors is deciding when and if a second major surgery, known as secondary cytoreductive surgery (SCS), will truly benefit the patient.

The Study's Focus: When is Surgery Best?

Currently, when the cancer returns, patients receive chemotherapy. The key question is whether adding a challenging surgery (SCS) to the chemotherapy offers better survival chances than chemotherapy alone. Past studies have suggested that SCS is only helpful if the surgeon can remove all visible signs of cancer.

The RESCUE study addresses this by using a modern, personalized approach:

Selection: The study enrolls patients whose cancer is platinum-sensitive (meaning it responded well to the initial platinum-based chemotherapy).

Pre-Surgical Test: Patients first receive several cycles of chemotherapy. During this time, the research team uses a special model to analyze how quickly a tumor marker called CA-125 decreases. This dynamic change in the marker helps doctors predict, with greater accuracy than ever before, which patients are most likely to achieve a complete resection (removal of all visible disease) during surgery.

Randomization: Patients who are identified as strong candidates for complete resection are then randomly assigned (like flipping a coin) into one of two groups:

Group 1 (Experimental): Receive the carefully planned secondary cytoreductive surgery followed by the rest of their chemotherapy.

Group 2 (Control): Continue with chemotherapy alone, without the surgery.

The Goal

The primary goal of the RESCUE study is to determine if adding secondary cytoreductive surgery provides a significant advantage in Progression-Free Survival (PFS)-the length of time a patient lives without their cancer getting worse-for this highly selected group of patients.

By meticulously selecting the patients most likely to benefit from surgery, this trial aims to establish a new standard of care, ensuring that this major surgical procedure is performed only when it is expected to yield the best possible outcome for the patient.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dae-Yeon Kim, MD. PhD.
  • Phone Number: +82-2-30103748
  • Email: kdyogt@gmail.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • The tumor is judged to be completely resectable by surgery (R0) based on the judgment of an experienced surgeon
  • Patients who provide signed and written informed consent and consent to data transfer and processing.

Exclusion Criteria:

  • 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.
  • Patients with platinum-refractory tumors (i.e., progression during chemotherapy or recurrence within 6 months after the end of the previous first platinum-containing regimen).
  • Cases where only palliative surgery is planned.
  • Radiological signs suggestive of metastasis that are considered completely unresectable.
  • Any comorbidity that precludes surgery and/or chemotherapy (e.g., poor general condition, severe infection, conditions that may cause severe bleeding, severe renal disease, etc.).
  • Any medical history that may cause excessive surgical risk pre- or post-operatively.
  • Medications being taken that pose a significant surgical risk (e.g., oral anticoagulants, bleeding risk due to bevacizumab).
  • Absence of evaluable archived tumor tissue.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgery
Neoadjuvant platinum-based chemotherapy and Secondary cytoreductive surgery followed by the remaining chemotherapy
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
Active Comparator: No surgery
platinum-based chemotherapy
Drug: Platinum Based Chemotherapy
Platinum Based Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
The length of time a patient lives with a cancer, without the disease getting worse or death from any cause.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
the date of randomization into the study arm until the date of death from any cause
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Complete Resection Rate (R0)
Time Frame: postoperative (up to 2 months after surgery)
The Complete Resection Rate is the percentage of patients in the surgical arm for whom the surgeon successfully removes all macroscopic (visible) tumor tissue (R0 status).
postoperative (up to 2 months after surgery)
Surgical Complication Rate
Time Frame: Postoperative (up to 2 months after surgery)
The Surgical Complication Rate measures the frequency and severity of adverse events, such as infections, bleeding, or wound healing problems (graded by Clavien-Dindo classification), experienced by patients in the Secondary Cytoreductive Surgery arm.
Postoperative (up to 2 months after surgery)
KELIM (The modeled CA-125 ELIMination rate constant K)
Time Frame: Baseline
The KELIM (The modeled CA-125 ELIMination rate constant K) Score will be evaluated as a secondary endpoint to confirm its prognostic accuracy in predicting the actual surgical outcome (Complete Resection Rate) and the long-term survival (PFS and OS) in the randomized patients.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Korean Gynecologic Oncology Group

Investigators

  • Principal Investigator: Dae-Yeon Kim, Asam Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 15, 2025

Primary Completion (Estimated)

November 15, 2029

Study Completion (Estimated)

November 15, 2029

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Actual)

December 19, 2025

Study Record Updates

Last Update Posted (Actual)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS-2025-02273048 (Other Grant/Funding Number: Korea Health Industry Development Institute(KHIDI))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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