UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041422 |
|---|---|
| Receipt number | R000047291 |
| Scientific Title | A histological cohort study to assess the safety and effectiveness of olaparib monotherapy in patients with platinum-sensitive relapsed ovarian cancer |
| Date of disclosure of the study information | 2020/10/27 |
| Last modified on | 2026/08/18 10:42:52 |
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Basic information
Public title
A historical cohort study to assess the safety and effectiveness of olaparib monotherapy in patients with platinum-sensitive relapsed ovarian cancer
Acronym
JGOG3026 RESPONSE study
Scientific Title
A histological cohort study to assess the safety and effectiveness of olaparib monotherapy in patients with platinum-sensitive relapsed ovarian cancer
Scientific Title:Acronym
JGOG3026 RESPONSE study
Region
| Japan |
Condition
Condition
Ovarian cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and effectiveness of olaparib monotherapy in patients with platinum-sensitive relapsed ovarian cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of adverse events during olaparib monotherapy in patients with platinum-sensitive relapsed ovarian cancer
Key secondary outcomes
Progression-free survival (PFS), PFS2, TFST, and OS in patients with platinum-sensitive relapsed ovarian cancer who received olaparib monotherapy.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
All patients with platinum-sensitive relapsed ovarian cancer who received olaparib monotherapy from January 2018 to July 2020.
Key exclusion criteria
1. platinum-resistant relapsed ovarian cancer
2. stable or progressive disease after platinum-based chemotherapy for patients with platinum-sensitive relapsed ovarian cancer
3. patients who had already received a PARP inhibitor before recurrence
4. patients who received both olaparib and bevacizumab combination maintenance therapy.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tayuki |
| Middle name | |
| Last name | Enomoto |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Obstetrics and Gynecology
Zip code
951-8510
Address
1-757, Asahimachi-dori, Chuo-ku, Niigata, Niigata, 951-8510, Japan
TEL
025-227-2320
enomoto@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Yoshihara |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Obstetrics and Gynecology
Zip code
951-8510
Address
1-757, Asahimachi-dori, Chuo-ku, Niigata, Niigata, 951-8510, Japan
TEL
025-227-2320
Homepage URL
yoshikou@med.niigata-u.ac.jp
Sponsor or person
Institute
Japanese Gynecologic Oncology Group (JGOG)
Institute
Department
Personal name
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
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
| 2020 | Year | 10 | Month | 27 | Day |
Related information
URL releasing protocol
https://ejgo.org/DOIx.php?id=10.3802/jgo.2027.38.e5
Publication of results
Published
Result
URL related to results and publications
https://ejgo.org/DOIx.php?id=10.3802/jgo.2027.38.e5
Number of participants that the trial has enrolled
471
Results
In the mITT1 (n = 413), any Grade 3 or more adverse events occurred in 41.6%. Anemia was the most common (28.8%). MDS occurred in 1.0% and no AML was observed during a mean follow-up of 34.1 months.
Results date posted
| 2026 | Year | 08 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We included patients who initiated olaparib maintenance therapy after platinum-based combination chemotherapy for platinum-sensitive first-relapsed ovarian, fallopian tube, or primary peritoneal cancer between January 2018 and July 2020.
Participant flow
We entered clinical data for the targeted patients in JGOG affiliated facilities into the TRI EDC system for analysis
Adverse events
An adverse event was defined as any unfavorable medical event that occurred during or after the clinical study. According to AstraZeneca's drug risk management plan of olaparib, myelosuppression (including anemia [32.4%], neutropenia [16.8%], leukopenia [13.8%], thrombocytopenia [9.5%], and lymphopenia [4.0%]) and interstitial lung disease (0.8%) were considered significant identified risks during clinical trials, and secondary malignant tumors, embryotoxicity, and patients with renal impairment were cited as critical potential risks. Therefore, safety information about CTCAE (version 5.0) Grade 3 or more adverse events and secondary malignant tumors (myelodysplastic syndrome [MDS], acute myeloid leukemia [AML], and others) with unknown incidence, which were classified as critical potential risks, was collected mainly during the study.
Outcome measures
The primary endpoint was the incidence of adverse events in patients who received olaparib maintenance therapy for platinum-sensitive first-relapsed ovarian cancer. The secondary endpoints were progression-free survival (PFS), time to first subsequent therapy (TFST), progression-free survival to the second progression (PFS2), and overall survival (OS) in patients who received olaparib maintenance therapy for platinum-sensitive first-relapsed ovarian cancer [4]. In addition, the details and effects of treatments for recurrence after olaparib maintenance therapy for platinum-sensitive first-relapsed ovarian cancer were assessed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Adverse events and prognosis in patients with platinum-sensitive relapsed ovarian cancer who received olaparib monotherapy
Management information
Registered date
| 2020 | Year | 08 | Month | 14 | Day |
Last modified on
| 2026 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047291
