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

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.

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.