Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT07295132
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RESCUE Study (REcurrent Ovarian Cancer Secondary Cytoreduction Using Chemotherapy rEsponse)
Sponsor:
Asan Medical Center
Organization:
Study Overview
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)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| RS-2025-02273048 | OTHER_GRANT | Korea Health Industry Development Institute(KHIDI) | View |