UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044136 |
|---|---|
| Receipt number | R000050402 |
| Scientific Title | Retrospective study of trifluridine/tipiracil hydrochloride plus bevacizumab for vulnerable patients with previously treated metastatic colorectal cancer(WJOG14520G) |
| Date of disclosure of the study information | 2021/05/10 |
| Last modified on | 2023/01/10 09:54:27 |
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Basic information
Public title
Retrospective study of trifluridine/tipiracil hydrochloride plus bevacizumab for vulnerable patients with previously treated metastatic colorectal cancer(WJOG14520G)
Acronym
Retrospective study of trifluridine/tipiracil hydrochloride plus bevacizumab for vulnerable patients with previously treated metastatic colorectal cancer(WJOG14520G)
Scientific Title
Retrospective study of trifluridine/tipiracil hydrochloride plus bevacizumab for vulnerable patients with previously treated metastatic colorectal cancer(WJOG14520G)
Scientific Title:Acronym
Retrospective study of trifluridine/tipiracil hydrochloride plus bevacizumab for vulnerable patients with previously treated metastatic colorectal cancer(WJOG14520G)
Region
| Japan |
Condition
Condition
Previously treated metastatic colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of trifluridine/tipiracil hydrochloride plus bevacizumab for vulnerable patients with previously treated metastatic colorectal cancer retrospectively
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Progression-free survival
Time to treatment failure
Objective response rate
Disease control rate
Adverse event
Proportion of subsequent therapy
Efficacies according to previous therapy and treatment line
Reason for being vulnerable
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) Histologically or cytologically diagnosed adenocarcinoma of the colon or rectum (excluding the appendix and anal canal)
2) Tumor is clinically determined to be unresectable for a radical cure
3) Age of 20 or older
4) ECOG PS of 0-2
5) Measurable or non-measurable lesion according to RECIST, version 1.1.
6) FTD/TPI plus BEV was started before 31st October 2020 without history of chemotherapy including fluoropyrimidine, oxaliplatin, or irinotecan.
7) History of chemotherapy prior to FTD/TPI plus BEV
8) Not identified as fit by investigator
9) Retained organ function
Key exclusion criteria
1) History of chemotherapy including regorafenib, FTD/TPI, or investigational drug prior to FTD/TPI plus BEV
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Hisato |
| Middle name | |
| Last name | Kawakami |
Organization
Kindai University Hospital
Division name
Department of Medical Oncology
Zip code
589-8511
Address
377-2 Ohno-Higashi, Osaka-Sayama, Osaka
TEL
072-366-0221
kawakami_h@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka, JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
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
Kindai university institutional Review Board
Address
377-2 Ohno-Higashi, Osaka-Sayama, Osaka
Tel
072-366-0221
zizen@med.kindai.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
| 2021 | Year | 05 | Month | 10 | 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
| 2021 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will review medical records and collect data.
Management information
Registered date
| 2021 | Year | 05 | Month | 07 | Day |
Last modified on
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050402
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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