UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056537 |
|---|---|
| Receipt number | R000064592 |
| Scientific Title | Database study on the current treatment status of elderly HER2-positive AGC patients |
| Date of disclosure of the study information | 2024/12/23 |
| Last modified on | 2026/03/05 11:55:25 |
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Basic information
Public title
Database study on the current treatment status of elderly HER2-positive AGC patients
Acronym
Database study on the current treatment status of elderly HER2-positive AGC patients
Scientific Title
Database study on the current treatment status of elderly HER2-positive AGC patients
Scientific Title:Acronym
Database study on the current treatment status of elderly HER2-positive AGC patients
Region
| Japan |
Condition
Condition
HER2 positive gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the treatment regimen selection proportion and subsequent treatment transition proportion in each treatment line of elderly patients with HER2-positive advanced gastric cancer (aGC) stratified by age and by how treatment intensive of 1L.
Additionally, by defining "less intensive treatment" as lesser treatment than standard of care (SOC) on the guidelines, to confirm the 2L or later treatment in patients receiving "less intensive treatment" in 1L.
Basic objectives2
Others
Basic objectives -Others
Database study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment regimen proportion for patients with HER2-positive aGC from 1L to 5L.
The transition proportion to next line treatment for patients with HER2-positive aGC from 1L to 4L.
Time to treatment failure (TTF), Duration of therapy, 1L regimen selection factors, Treatment transition factors, Treatment duration factors.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
Male and Female
Key inclusion criteria
Patients who meet all the following conditions:
Patients with disease codes (ICD-10 codes) for malignant neoplasms of stomach or esophagus
Patients with a history of trastuzumab administration
Patients who are 18 years of age or older at the start of 1L therapy.
Key exclusion criteria
Patients with disease codes for the following conditions are excluded:
Patients who underwent gastric resection before and after 1L chemotherapy
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Kazuto |
| Middle name | |
| Last name | Sato |
Organization
Daiichi Sankyo Co., Ltd.
Division name
Oncology Medical Science Department I
Zip code
103-8426
Address
3-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
TEL
03-6225-1111
kazuto.sato@daiichisankyo.com
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Tsuchida |
Organization
Daiichi Sankyo Co., Ltd.
Division name
Oncology Medical Science Department I
Zip code
103-8426
Address
3-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
TEL
03-6225-1111
Homepage URL
kenji.tsuchida@daiichisankyo.com
Sponsor or person
Institute
Daiichi Sankyo Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Daiichi Sankyo Co., Ltd.
Address
3-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
Tel
03-6225-1111
kenji.tsuchida@daiichisankyo.com
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
| 2024 | Year | 12 | Month | 23 | 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
Completed
Date of protocol fixation
| 2024 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort study using the database
Management information
Registered date
| 2024 | Year | 12 | Month | 23 | Day |
Last modified on
| 2026 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064592
