UMIN-CTR Clinical Trial

Basic information
Public title	A historical cohort study to examine the safety and efficacy of olaparib maintenance therapy after initial treatment for advanced ovarian cancer
Acronym	JGOG3027
Scientific Title	A historical cohort study to examine the safety and efficacy of olaparib maintenance therapy after initial treatment for advanced ovarian cancer
Scientific Title:Acronym	JGOG3027
Region	Japan

Condition
Condition	Ovarian cancer
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of adverse events in patients who received olaparib maintenance therapy for newly diagnosed advanced ovarian cancer
Key secondary outcomes	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

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key 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
Key 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
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Terumi Middle name Last name Tanigawa
Organization	The Cancer Institute Hospital of JFCR
Division name	Gynecologic Oncology
Zip code	135-8550
Address	3-8-31, Ariake, Koto, Tokyo 135-8550, Japan
TEL	03-3520-0111
Email	terumi.tanigawa@jfcr.or.jp

Public contact
Name of contact person	1st name Terumi Middle name Last name Tanigawa
Organization	The Cancer Institute Hospital of JFCR
Division name	Gynecologic Oncology
Zip code	135-8550
Address	3-8-31, Ariake, Koto, Tokyo 135-8550, Japan
TEL	03-3520-0111
Homepage URL
Email	terumi.tanigawa@jfcr.or.jp

Sponsor
Institute	Japanese Gynecologic Oncology Group (JGOG)
Institute
Department

Funding Source
Organization	Japanese Gynecologic Oncology Group (JGOG)
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Japanese Gynecologic Oncology Group
Address	4F, Komatsu Building, 6-22, Kagurazaka, Shinjuku-ku, Tokyo, 162-0825, Japan
Tel	03-5206-1982
Email	info@jgog.gr.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2021 Year 02 Month 19 Day
Date of IRB	2021 Year 08 Month 04 Day
Anticipated trial start date	2021 Year 04 Month 01 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Adverse events and prognosis in patients with newly diagnosed advanced ovarian cancer (including fallopian tube cancer and primary peritoneal cancer) who received olaparib monotherapy

Management information
Registered date	2021 Year 03 Month 01 Day
Last modified on	2022 Year 09 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049618