RESCUE Study (REcurrent Ovarian Cancer Secondary Cytoreduction Using Chemotherapy rEsponse) (NCT07295132) | Clinical Trial Compass
Not Yet RecruitingPhase 2
RESCUE Study (REcurrent Ovarian Cancer Secondary Cytoreduction Using Chemotherapy rEsponse)
160 participantsStarted 2025-12-15
Plain-language 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.
Who can participate
Age range19 Years
SexFEMALE
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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 p…
What they're measuring
1
Progression-Free Survival
Timeframe: 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