UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter Retrospective Cohort Study Evaluating the Safety and Efficacy of Regorafenib in Patients with Metastatic Colorectal Cancer; the HGCSG1401 Study
Title of the study (Brief title)	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	Yoshito Komatsu
Organization	Hokkaido University Hospital
Division name	Cancer Center
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	Satoshi Yuki
Organization	Hokkaido University Hospital
Division name	Gastroenterology and Hepatology
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 03 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://meetinglibrary.asco.org/content/174622-195
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024078