Ovarian Cancer RecurrentPhase 2NCT07295132
RESCUE Study (REcurrent Ovarian Cancer Secondary Cytoreduction Using Chemotherapy rEsponse)
A Phase 2 study testing Secondary cytoreductive surgery and Platinum Based Chemotherapy in people with Ovarian Cancer Recurrent and Platinum Sensitive Ovarian Cancer, run by Asan Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Ovarian Cancer Recurrent, Platinum Sensitive Ovarian Cancer
- What is being tested?
- Secondary cytoreductive surgery and Platinum Based Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 15 Nov 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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)
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.
Read the 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.
- Being tested
- Secondary cytoreductive surgery, Platinum Based Chemotherapy
- Keywords
- platinum sensitive recurrent ovarian cancer, secondary cytoreductive surgery, neoadjuvant chemotherapy, CA-125 response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secondary cytoreductive surgeryProcedure or 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).
Platinum Based ChemotherapyDrug
Platinum Based Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Neoadjuvant platinum-based chemotherapy and Secondary cytoreductive surgery followed by the remaining chemotherapy Receives: Procedure: Secondary cytoreductive surgery; Drug: Platinum Based Chemotherapy |
| No surgery | Active comparator | platinum-based chemotherapy Receives: Drug: Platinum Based Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
The length of time a patient lives with a cancer, without the disease getting worse or death from any cause.
Measured: 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 outcomes (4)
Overall Survival
the date of randomization into the study arm until the date of death from any cause
Measured: 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)
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).
Measured: postoperative (up to 2 months after surgery)
Surgical Complication Rate
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.
Measured: Postoperative (up to 2 months after surgery)
KELIM (The modeled CA-125 ELIMination rate constant K)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion15 Nov 2029 (estimated)
- Study completion15 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cancer RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study, following neoadjuvant chemotherapy, patients are randomized to one of two arms: either receiving Secondary Cytoreductive Surgery followed by the remaining chemotherapy, or continuing with chemotherapy alone, in order to evaluate which strategy leads to superior Progression-Free Survival.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Gynecologic Oncology Group
- Responsible party
- Principal investigator, Dae-Yeon Kim, Asan Medical Center
- Investigators
- Dae-Yeon Kim, Principal investigator, Asam Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295132
- Sponsor's protocol ID
- RS-2025-02273048
- Other IDs
- RS-2025-02273048
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07295132
- Acronym / sponsor ID
- RS-2025-02273048
- Keywords
- platinum sensitive recurrent ovarian cancer, secondary cytoreductive surgery, neoadjuvant chemotherapy, CA-125 response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Korean Gynecologic Oncology Group
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 15 Nov 2029 (estimated)
- Study completion
- 15 Nov 2029 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this study, following neoadjuvant chemotherapy, patients are randomized to one of two arms: either receiving Secondary Cytoreductive Surgery followed by the remaining chemotherapy, or continuing with chemotherapy alone, in order to evaluate which strategy leads to superior Progression-Free Survival.
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Procedure: Secondary cytoreductive surgery, Drug: Platinum Based ChemotherapyNeoadjuvant platinum-based chemotherapy and Secondary cytoreductive surgery followed by the remaining chemotherapy |
| No surgery | Active comparator | Drug: Platinum Based Chemotherapyplatinum-based chemotherapy |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Secondary cytoreductive surgerySecondary 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). | Procedure or surgery | Surgery |
| Platinum Based ChemotherapyPlatinum Based Chemotherapy | Drug | No surgery, Surgery |
Primary outcome
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.
4 secondary outcomes
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
Complete Resection Rate (R0)
Time frame: postoperative (up to 2 months after surgery)
Surgical Complication Rate
Time frame: Postoperative (up to 2 months after surgery)
KELIM (The modeled CA-125 ELIMination rate constant K)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dae-Yeon Kim principal investigator
Asam Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Secondary cytoreductive surgery and Platinum Based Chemotherapy in people with Ovarian Cancer Recurrent and Platinum Sensitive Ovarian Cancer, run by Asan Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dae-Yeon Kim, MD. PhD. (+82-2-30103748, kdyogt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.