UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041621 |
|---|---|
| Receipt number | R000047508 |
| Scientific Title | Pooled safety and efficacy analysis of trifluridine/tipiracil plus bevacizumab in five clinical trials using individual data from patients with metastatic colorectal cancer |
| Date of disclosure of the study information | 2020/09/15 |
| Last modified on | 2023/06/23 14:40:21 |
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Basic information
Public title
Pooled safety and efficacy analysis of trifluridine/tipiracil plus bevacizumab in five clinical trials using individual data from patients with metastatic colorectal cancer
Acronym
Pooled safety and efficacy analysis of trifluridine/tipiracil plus bevacizumab in five clinical trials using individual data from patients with metastatic colorectal cancer
Scientific Title
Pooled safety and efficacy analysis of trifluridine/tipiracil plus bevacizumab in five clinical trials using individual data from patients with metastatic colorectal cancer
Scientific Title:Acronym
Pooled safety and efficacy analysis of trifluridine/tipiracil plus bevacizumab in five clinical trials using individual data from patients with metastatic colorectal cancer
Region
| Japan |
Condition
Condition
metastatic colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of trifluridine/tipiracil plus bevacizumab for metastatic colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of adverse events
Response to treatment
Disease control rate
Objective response rate
Overall survival
Progression free survival
Time to treatment failure
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. All patients enrolled in clinical trials of trifluridine/tipiracil hydrochloride (FTD/TPI) plus bevacizumab conducted in Japan for which individual case data were available were included.
Key exclusion criteria
Nothing in particular
Target sample size
239
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Yamazaki |
Organization
Shizuoka Cancer Center
Division name
Division of Gastrointestinal Oncology
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777
TEL
055-989-5222
k.yamazaki@scchr.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kawakami |
Organization
Shizuoka Cancer Center
Division name
Division of Gastrointestinal Oncology
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777
TEL
055-989-5222
Homepage URL
t.kawakami@scchr.jp
Sponsor or person
Institute
The 22nd Century Cutting-Edge Medical Informaion Technology Organization
Institute
Department
Personal name
Funding Source
Organization
TAIHO PHARMACEUTICAL 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
IRB of Shizuoka Cancer Center
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777
Tel
055-989-5222
n/a
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 | 09 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Incidence of adverse events
Response to treatment
Disease control rate
Objective response rate
Overall survival
Progression free survival
Time to treatment failure
Management information
Registered date
| 2020 | Year | 08 | Month | 31 | Day |
Last modified on
| 2023 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047508
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
