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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Asan Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Korean Gynecologic Oncology Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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