ovarian cancer
Conditions
Interventions
None listed
Sponsors
Japanese Gynecologic Oncology Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese female patients aged 18 years or older at the time of obtaining consent 2. Patients with a confirmed diagnosis of High-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer 3. Patients willing to submit a neutral buffered formalin-fixed paraffin-embedded (FFPE) block of tumor tissue for storage or a newly prepared FFPE thin section with a designated glass slide 4. Enrollment Criterion A only: Patients with platinum-resistant disease: a. Patients who have only had 1 line of platinum based therapy must have received at least 4 cycles of platinum, must have had a response (CR or PR) and then progressed between > 3 months and <= 6 months after the date last dose of platinum b. Patients who have received 2 or 3 lines of platinum therapy must have progressed on or within 6 months after the date of the last dose of platinum. Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression Note: Patients who are platinum-refractory during front-line treatment are excluded (see exclusion criteria). 5. Enrollment Criterion B only: Patients with platinum-sensitive disease: a. Patients undergoing platinum-containing chemotherapy in combination with bevacizumab after platinum-sensitive recurrence 6. Patients who are judged by the principal investigator or sub-investigator to have the ability to understand and comply with the contents of the clinical study 7. Patients who are able to sign and date the Informed consent form prior to enrollment in the study
Exclusion criteria
Exclusion criteria: 1. Patients for whom there are not enough specimens for the study 2. Endometrioid, clear cell, mucinous or sarcoma histology or any of these histological types Patients with mixed oncology or low-atypical or borderline ovarian oncology. 3. Enrollment Criterion A only: Patients who demonstrated platinum refractory during first-line therapy 4. Other patients who are judged to be inappropriate for the study by the principal investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FRalpha positivity rate | — |
Countries
Japan
Contacts
Public ContactAkira Yabuno
Saitama Medical University International Medical Center Department of Gynecologic Oncology
Outcome results
None listed