Ovarian cancer
Conditions
Interventions
None listed
Sponsors
Japanese Gynecologic Oncology Group (JGOG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Female patients with newly diagnosed, histologically confirmed, advanced (International Federation of Gynecology and Obstetrics FIGO stage III-IV) BRCA mutated ovarian cancer, primary peritoneal cancer and/or fallopian tube cancer who have completed first-line, platinum-based chemotherapy 2.Patients with complete or partial response after initial treatment with platinum-based combination chemotherapy 3.Patients in which olaparib maintenance therapy was started between June 2019 and March 2012 4.Patients aged 18 years or older (without upper age limit) at the time of enrollment 5. Patients must have a tissue biopsy or tumor debulking surgery 6. Platinum-based chemotherapy course must have consisted of a minimum of six treatment cycles and a maximum of nine; however, if platinum-based therapy must be discontinued early as a result of toxicities specifically related to the platinum regimen, patients must have received a minimum of four cycles of the platinum regimen 7. Patients must be started olaparib maintenance therapy within 8 weeks after their last dose of chemotherapy (last dose is the day of the last infusion) 8. Patients must have normal organ and bone marrow function 9. Eastern Cooperative Oncology Group performance status 0-1 10. Patients must have a life expectancy 16 weeks or more
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events in patients who received olaparib maintenance therapy for newly diagnosed advanced ovarian cancer | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression-free survival (PFS) 2. Overall survival (OS) 3. Details and effect of treatments given after olaparib maintenance therapy for first-relapsed ovarian cancer 4. Therapeutic effect (treatment period) and adverse events of PARP inhibitor re-administration for platinum-sensitive first-relapsed ovarian cancer 5. Incidence of secondary cancer | — |
Countries
Japan
Contacts
Public ContactTerumi Tanigawa
The Cancer Institute Hospital of JFCR Gynecologic Oncology
Outcome results
None listed