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

NCT07295132 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: RS-2025-02273048
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Platinum Sensitive Ovarian Cancer; Ovarian Cancer Recurrent

Keywords

platinum sensitive recurrent ovarian cancer; secondary cytoreductive surgery; neoadjuvant chemotherapy; CA-125 response

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  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 Outcomes (4)

• Overall Survival

  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)

  postoperative (up to 2 months after surgery)

• Surgical Complication Rate

  Postoperative (up to 2 months after surgery)

• KELIM (The modeled CA-125 ELIMination rate constant K)

  Baseline

Study Arms (2)

Surgery

EXPERIMENTAL

Neoadjuvant platinum-based chemotherapy and Secondary cytoreductive surgery followed by the remaining chemotherapy

Procedure: Secondary cytoreductive surgery; Drug: Platinum Based Chemotherapy

No surgery

ACTIVE COMPARATOR

platinum-based chemotherapy

Drug: Platinum Based Chemotherapy

Interventions

Platinum Based Chemotherapy DRUG

Platinum Based Chemotherapy

No surgery; Surgery

Secondary cytoreductive surgery PROCEDURE

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).

Surgery

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead
• Korean Gynecologic Oncology Group: collaborator

MeSH Terms

Interventions

Platinum Compounds

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

• Dae-Yeon Kim

  Asam Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dae-Yeon Kim, MD. PhD.

CONTACT

+82-2-30103748; kdyogt@gmail.com

Hyun-Woong Cho, MD. PhD.

CONTACT

+82-2-30101033; limpcho82@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 19, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): November 15, 2029
• Study Completion (Estimated): November 15, 2029
• Last Updated: December 19, 2025

Record last verified: 2025-12