UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051378 |
|---|---|
| Receipt number | R000058618 |
| Scientific Title | A retrospective observational study of trifluridine tipiracil plus minus bevacizumab in pretreated mCRC patients with MSI-H MMR-D metastatic colorectal cancer |
| Date of disclosure of the study information | 2023/06/19 |
| Last modified on | 2023/06/21 15:55:21 |
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Basic information
Public title
A retrospective observational study of trifluridine tipiracil plus minus bevacizumab in pretreated mCRC patients with MSI-H MMR-D metastatic colorectal cancer
Acronym
A retrospective observational study of trifluridine tipiracil plus minus bevacizumab in pretreated mCRC patients with MSI-H MMR-D metastatic colorectal cancer
Scientific Title
A retrospective observational study of trifluridine tipiracil plus minus bevacizumab in pretreated mCRC patients with MSI-H MMR-D metastatic colorectal cancer
Scientific Title:Acronym
A retrospective observational study of trifluridine tipiracil plus minus bevacizumab in pretreated mCRC patients with MSI-H MMR-D metastatic colorectal cancer
Region
| Japan |
Condition
Condition
Metastatic colorectal cancer with microsatellite instability high (MSI-H) mismatch repair deficient (MMR-D)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify the efficacy and safety of Trifluridine/tipiracil (FTD/TPI) plus minus bevacizumab (BV) for mCRC with MSI-H/MMR-D
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
progression free survival
time to treatment failure
objective response rate
disease control rate
overall survival
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Metastatic colorectal cancer with histologically proven colorectal adenocarcinoma
2.Received trifluridine tipiracil plus minus BV between June 2012 and January 2023
3.Microsatellite instability or mismatch repair deficiency was determined by some diagnostic methods
4.ECOG Performance Status of 0-2
Key exclusion criteria
1.Presence of multiple life threatening cancers
2.Inappropriate cases by physicians judgement
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Toshiki |
| Middle name | |
| Last name | Masuishi |
Organization
Toshiki Masuishi
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku Nagoya 464-8681
TEL
052-762-6111
tmasuishi@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Hasegawa |
Organization
National Hospital Organization Osaka National Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
540-0006
Address
2-1-14 Hoenzaka, Chuo-ku, Osaka, OSAKA
TEL
06-6942-1331
Homepage URL
hasegawa.hiroko.yr@mail.hosp.go.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
National Hospital Organization Osaka National Hospital
Address
2-1-14 Hoenzaka, Chuo-ku, Osaka, OSAKA
Tel
06-6942-1331
408-chiken@mail.hosp.go.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
| 2023 | Year | 06 | Month | 19 | 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
| 2023 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To clarify the efficacy and safety of Trifluridine/tipiracil FTD/TPI plus minus bevacizumab (BV) for mCRC with MSI-H/MMR-D
Management information
Registered date
| 2023 | Year | 06 | Month | 19 | Day |
Last modified on
| 2023 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058618
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
