UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040853 |
|---|---|
| Receipt number | R000046480 |
| Scientific Title | A retrospective observational study of monotherapy outcomes on the efficacy of third-line or later treatment for patients with HER2 positive unresectable recurrent or metastatic gastric cancer previously treated with trastuzumab |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2021/10/11 18:22:47 |
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Basic information
Public title
A retrospective observational study of monotherapy outcomes on the efficacy of third-line or later treatment for patients with HER2 positive unresectable recurrent or metastatic gastric cancer previously treated with trastuzumab
Acronym
A retrospective observational study of monotherapy outcomes on the efficacy of third-line or later treatment for patients with HER2 positive unresectable recurrent or metastatic gastric cancer previously treated with trastuzumab
Scientific Title
A retrospective observational study of monotherapy outcomes on the efficacy of third-line or later treatment for patients with HER2 positive unresectable recurrent or metastatic gastric cancer previously treated with trastuzumab
Scientific Title:Acronym
A retrospective observational study of monotherapy outcomes on the efficacy of third-line or later treatment for patients with HER2 positive unresectable recurrent or metastatic gastric cancer previously treated with trastuzumab
Region
| Japan |
Condition
Condition
HER2 positive unresectable recurrent or metastatic gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the treatment efficacy of single-agent treatment (nivolumab [Nivo], irinotecan [CPT-11], and trifluridine tipiracil [FTD/TPI]) as third line or later for patients with HER2 positive gastric cancer previously treated with trastuzumab (T-mab).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival, Real world, Progression-free survival, Duration of response, Time to treatment failure, Objective response rate, Disease control rate
Key secondary outcomes
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
Male and Female
Key inclusion criteria
1) Age 20 years or older, at the start of administration
2) Patients diagnosed as HER2 positive gastric cancer by pathological examination in their charts
3) Patients diagnosed with unresectable advanced or recurrent gastric cancer
4) Patients previously treated with T-mab
5) Patients who have started treatment with either Nivo, CPT-11 or FTD/TPI as a single agent in the third-line or later treatment between September 22, 2017 (date to be approved the expanded indication of Nivo for gastric cancer in Japan) and March 31, 2020.
Key exclusion criteria
1) Patients who declined this study before database lock
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Doki |
Organization
Graduate school of Medicine OSAKA University
Division name
Department of Gastroenterological Surgery
Zip code
565-0871
Address
2-15 Yamadaoka, Suita, Osaka 565-0871
TEL
06-6210-8318
dsakai@cfs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Sakai |
Organization
Graduate school of Medicine OSAKA University
Division name
Department of Frontier Science for Cancer and Chemotherapy
Zip code
565-0871
Address
2-15 Yamadaoka, Suita, Osaka 565-0871
TEL
06-6210-8318
Homepage URL
dsakai@cfs.med.osaka-u.ac.jp
Sponsor or person
Institute
Graduate school of Medicine OSAKA UniversityDepartment of Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO CO.,LTD.
Oncology medical science departmen
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
Osaka University Clinical Research Review Committee
Address
2-15 Yamadaoka, Suita, Osaka 565-0871
Tel
06-6879-5111
dsakai@cfs.med.osaka-u.ac.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 | 07 | 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
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-
Management information
Registered date
| 2020 | Year | 06 | Month | 22 | Day |
Last modified on
| 2021 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046480
