Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT07295132
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
19 Years
Study:
NCT07295132
Study Brief:
Protocol Section:
NCT07295132