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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044136
Receipt No. 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 2021/11/19

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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
Email 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
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

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
Email 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 Open public recruiting
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
2021 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050402

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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