Unique ID issued by UMIN | UMIN000043474 |
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Receipt number | R000049618 |
Scientific Title | A historical cohort study to examine the safety and efficacy of olaparib maintenance therapy after initial treatment for advanced ovarian cancer |
Date of disclosure of the study information | 2021/04/01 |
Last modified on | 2022/09/02 12:39:37 |
A historical cohort study to examine the safety and efficacy of olaparib maintenance therapy after initial treatment for advanced ovarian cancer
JGOG3027
A historical cohort study to examine the safety and efficacy of olaparib maintenance therapy after initial treatment for advanced ovarian cancer
JGOG3027
Japan |
Ovarian cancer
Obstetrics and Gynecology |
Malignancy
NO
The primary objective of the study is to evaluate the details, safety, and efficacy of olaparib maintenance therapy in patients with newly diagnosed advanced ovarian cancer (including fallopian tube cancer and primary peritoneal cancer) in Japan, and this study's secondary objective is to conduct a fact-finding survey on treatment given after the olaparib maintenance therapy.
Safety,Efficacy
Incidence of adverse events in patients who received olaparib maintenance therapy for newly diagnosed advanced ovarian cancer
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
Observational
18 | years-old | <= |
Not applicable |
Female
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
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
300
1st name | Terumi |
Middle name | |
Last name | Tanigawa |
The Cancer Institute Hospital of JFCR
Gynecologic Oncology
135-8550
3-8-31, Ariake, Koto, Tokyo 135-8550, Japan
03-3520-0111
terumi.tanigawa@jfcr.or.jp
1st name | Terumi |
Middle name | |
Last name | Tanigawa |
The Cancer Institute Hospital of JFCR
Gynecologic Oncology
135-8550
3-8-31, Ariake, Koto, Tokyo 135-8550, Japan
03-3520-0111
terumi.tanigawa@jfcr.or.jp
Japanese Gynecologic Oncology Group (JGOG)
Japanese Gynecologic Oncology Group (JGOG)
Non profit foundation
Japanese Gynecologic Oncology Group
4F, Komatsu Building, 6-22, Kagurazaka, Shinjuku-ku, Tokyo, 162-0825, Japan
03-5206-1982
info@jgog.gr.jp
NO
2021 | Year | 04 | Month | 01 | Day |
Unpublished
No longer recruiting
2021 | Year | 02 | Month | 19 | Day |
2021 | Year | 08 | Month | 04 | Day |
2021 | Year | 04 | Month | 01 | Day |
2026 | Year | 03 | Month | 31 | Day |
Adverse events and prognosis in patients with newly diagnosed advanced ovarian cancer (including fallopian tube cancer and primary peritoneal cancer) who received olaparib monotherapy
2021 | Year | 03 | Month | 01 | Day |
2022 | Year | 09 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049618
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