A historical cohort study to examine the safety and efficacy of olaparib maintenance therapy after initial treatment for advanced ovarian cancer - JGOG3027

Japanese Gynecologic Oncology Group (JGOG)0 sites300 target enrollmentApril 1, 2021

Overview

No summary available.

Registry

who.int

Start Date

April 1, 2021

End Date

March 31, 2026

Last Updated

2 years ago

Study Type

Observational

Sex

Female

Sponsor

Japanese Gynecologic Oncology Group (JGOG)

•1\. Patients who have not confirmed a complete response (CR) or partial response (PR) by diagnostic imaging after initial treatment with platinum\-based combination chemotherapy 2\. Patients with early stage disease (FIGO Stage I, IIA, IIB, or IIC) 3\. Patients who have had drainage of their ascites before olaparib maintenance therapy 4\. Patients participating in other clinical studies 5\. Patients with active double cancer 6\. Persistent toxicities (Common Terminology Criteria for Adverse Events grade 2 or more) caused by previous cancer therapy, excluding alopecia 7\. Patients with myelodysplastic syndrome/acute myeloid leukemia 8\. Previous allogeneic bone marrow transplant 9\. Patients with symptomatic uncontrolled brain metastases 10\. Patients who were previously treated with poly (ADP\-ribose) polymerase (PARP) inhibitors before olaparib maintenance therapy 11\. Patients in which a molecular\-targeted drug or immune checkpoint inhibitor is administered at the start of olaparib maintenance therapy (patients in which administration has been completed before the start of olaparib maintenance therapy can be registered) 12\. BRCA1 and/or BRCA2 mutations that are considered to be non\-detrimental and variant of uncertain significance (VUS) 13\. Patients disqualified from participation in the study by the investigator