UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020861
Receipt number R000024078
Scientific Title Multicenter Retrospective Cohort Study Evaluating the Safety and Efficacy of Regorafenib in Patients with Metastatic Colorectal Cancer; the HGCSG1401 Study
Date of disclosure of the study information 2016/02/03
Last modified on 2017/02/03 18:48:35

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Basic information

Public title

Multicenter Retrospective Cohort Study Evaluating the Safety and Efficacy of Regorafenib in Patients with Metastatic Colorectal Cancer; the HGCSG1401 Study

Acronym

Multicenter Retrospective Cohort Study of Regorafenib; the HGCSG1401 Study

Scientific Title

Multicenter Retrospective Cohort Study Evaluating the Safety and Efficacy of Regorafenib in Patients with Metastatic Colorectal Cancer; the HGCSG1401 Study

Scientific Title:Acronym

Multicenter Retrospective Cohort Study of Regorafenib; the HGCSG1401 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 Regorafenib 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 Regorafenib.
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

200


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 or person

Institute

Hokkaido Gastrointestinal Cancer Study Group

Institute

Department

Personal name



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

NTT東日本札幌病院(北海道), 市立函館病院(北海道), 札幌医科大学(北海道), 苫小牧市立病院(北海道), 斗南病院(北海道), 弘前大学(青森県), 札幌東徳洲会病院(北海道), 北海道大学病院(北海道), 岩見沢市立総合病院(北海道), 東京大学病院(東京都), 市立札幌病院(北海道), 手稲渓仁会病院(北海道), 秋田赤十字病院(秋田県), 恵佑会札幌病院(北海道), 函館中央病院(北海道), 苫小牧日翔病院(北海道), 長崎大学病院(長崎県), 釧路労災病院(北海道), 北海道消化器科病院(北海道), 札幌北楡病院(北海道)


Other administrative information

Date of disclosure of the study information

2016 Year 02 Month 03 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://meetinglibrary.asco.org/content/174622-195

Number of participants that the trial has enrolled


Results

RR and disease control rate (DCR) were 1.3% and 29.6%, respectively. Median PFS and median survival time (MST) were 2.1 and 6.3 months.

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

Main results already published

Date of protocol fixation

2014 Year 03 Month 17 Day

Date of IRB


Anticipated trial start date

2014 Year 07 Month 24 Day

Last follow-up date

2016 Year 04 Month 01 Day

Date of closure to data entry

2016 Year 06 Month 01 Day

Date trial data considered complete

2016 Year 09 Month 01 Day

Date analysis concluded



Other

Other related information

Retrospective Cohort Study


Management information

Registered date

2016 Year 02 Month 03 Day

Last modified on

2017 Year 02 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024078


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name