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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020551
Receipt No. R000023727
Scientific Title Multicenter Retrospective Cohort Study Evaluating the Safety and Efficacy of TAS-102 in Patients with Metastatic Colorectal Cancer; the HGCSG1503 Study
Date of disclosure of the study information 2016/02/02
Last modified on 2018/07/16

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Basic information
Public title Multicenter Retrospective Cohort Study Evaluating the Safety and Efficacy of TAS-102 in Patients with Metastatic Colorectal Cancer; the HGCSG1503 Study
Acronym Multicenter Retrospective Cohort Study of TAS-102; the HGCSG1503 Study
Scientific Title Multicenter Retrospective Cohort Study Evaluating the Safety and Efficacy of TAS-102 in Patients with Metastatic Colorectal Cancer; the HGCSG1503 Study
Scientific Title:Acronym Multicenter Retrospective Cohort Study of TAS-102; the HGCSG1503 Study
Region
Japan

Condition
Condition Colorectal Cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of daily practice use of TAS-102 for patients with metastatic or unresectable colorectal cancer.
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, Response rate, Disease control rate, Time to treatment failure, Adverse events, Relative dose intensity, Detail of subsequent treatment

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) Patients who were treated with TAS-102.
2) Histologically confirmed colorectal adenocarcinoma
3) Unresectable metastatic or local advanced colorectal cancer
4) Age <=20 years old
Key exclusion criteria 1) Active double cancers
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshito Komatsu
Organization Hokkaido University Hospital
Division name Cancer Center
Zip code
Address Kita-14, Nishi-5, Kita-ku, Sapporo, Hokkaido
TEL 011-716-1161
Email ykomatsu@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Yuki
Organization Hokkaido University Hospital
Division name Gastroenterology and Hepatology
Zip code
Address Kita-14, Nishi-5, Kita-ku, Sapporo, Hokkaido
TEL 011-716-1161
Homepage URL
Email satoshi-yuuki175@joy.ocn.ne.jp

Sponsor
Institute Hokkaido Gastrointestinal Cancer Study Group
Institute
Department

Funding Source
Organization Hokkaido Gastrointestinal Cancer Study Group
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 北海道大学病院(北海道)、斗南病院(北海道)、市立函館病院(北海道)、釧路労災病院(北海道)、王子総合病院(北海道)、恵佑会札幌病院(北海道)、厚生連高岡病院(富山件)、北海道消化器科病院(北海道)、長崎大学病院(長崎県)、北見赤十字病院(北海道)、札幌東徳洲会病院(北海道)、NTT東日本札幌病院(北海道)、北海道がんセンター(北海道)、市立稚内病院(北海道)、市立札幌病院(北海道)、伊達赤十字病院(北海道)、手稲渓仁会病院(北海道)、帯広厚生病院(北海道)、富山赤十字病院(富山県)、苫小牧日翔病院(北海道)、秋田赤十字病院(秋田県)、札幌医科大学(北海道)、北海道医療センター(北海道)、札幌医科大学(北海道)、中通総合病院(秋田県)、札幌北楡病院(北海道)、市立旭川病院(北海道)、岩見沢市立総合病院(北海道)、市立秋田総合病院(秋田県)、苫小牧市立病院(北海道)、富山大学(富山県)

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

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
2015 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 01 Day
Last follow-up date
2017 Year 04 Month 30 Day
Date of closure to data entry
2017 Year 04 Month 30 Day
Date trial data considered complete
2017 Year 05 Month 31 Day
Date analysis concluded

Other
Other related information Retrospective Cohort Study

Management information
Registered date
2016 Year 01 Month 13 Day
Last modified on
2018 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023727

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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