UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A retrospective analysis of regorafenib and TAS-102 for advanced or recurrent colorectal cancer
Title of the study (Brief title)	RETAS study
Region	Japan

Condition
Condition	advanced or recurrent colorectal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We retrospectively evaluated the effectiveness and safety of Regorafenib and TAS-102.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	safety (hematological and non-hematological adverse event)
Key secondary outcomes	Response rate Disease control rate Progression free survival Overall survival

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	46 years-old <=
Age-upper limit	81 years-old >=
Gender	Male and Female
Key inclusion criteria	Advanced or recurrent colorectal cancer patient adminisitered Regorafenib or TAS-102 in periods from March, 2013 to April, 2016 at Sapporo City General Hospital
Key exclusion criteria	The case that an image evaluation was never accomplished
Target sample size	18

Research contact person
Name of lead principal investigator	Masataka Yagisawa
Organization	Sapporo City General Hospital
Division name	Department of Gastroenterology
Address	1-1, Kita 11, Nishi 13, Chuo, Sapporo, Hokkaido
TEL	080-1104-6869
Email	yagisawa.m@hotmail.co.jp

Public contact
Name of contact person	Masataka Yagisawa
Organization	Sapporo City General Hospital
Division name	medical office
Address	1-1, Kita 11, Nishi 13, Chuo, Sapporo, Hokkaido
TEL	011-726-2211
Homepage URL
Email	yagisawa.m@hotmail.co.jp

Sponsor
Institute	Sapporo City General Hospital
Institute
Department

Funding Source
Organization	none
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

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 18 Day
Anticipated trial start date	2016 Year 04 Month 19 Day
Last follow-up date	2018 Year 01 Month 01 Day
Date of closure to data entry	2018 Year 01 Month 01 Day
Date trial data considered complete	2018 Year 01 Month 01 Day
Date analysis concluded	2018 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	none

Management information
Registered date	2016 Year 09 Month 20 Day
Last modified on	2018 Year 09 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027762