UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Regorafenib versus TAS-102 as Salvage-line in patients with colorectal cancer refractory to standard chemotherapies: a multicenter observational study
Title of the study (Brief title)	Regorafenib versus TAS-102: a multicenter, retrospective observational study (REGOTAS)
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Gastroenterology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy and safety between regorafenib alone and TAS-102 alone in patients with colorectal cancer refractory to standard chemotherapies
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, time to ECOG PS >=2, incidence of adverse events, detail of subsequent treatment, and comparison between patients with initial dose reduction and patients without it.

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 or TAS-102 between 26th May 2014 and 30th September 2015. 2) Histologically proven colorectal adenocarcinoma 3) Unresectable colorectal cancer 4) Refractory to fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, and anti-EFGR antibody (limited KRAS or RAS wild type) 5) With measurable or evaluable lesion 6) Age <=20 years old 7) ECOG PS 0 to 2
Key exclusion criteria	1) Prior therapy with regorafenib or TAS-102 2) Active infections 3) Symptomatic brain metastasis 4) Active double cancers 5) Serious complications 6) Uncontrolled thromboembolism 7) Comorbidity with systemic steroid therapy
Target sample size	600

Research contact person
Name of lead principal investigator	Yasuhiro Shimada
Organization	Kochi Health Sciences Center
Division name	Division of Clinical Oncology
Address	2125-1, Ike, Kochi city, Kochi
TEL	088-837-3000
Email	yasuhiro_shimada@khsc.or.jp

Public contact
Name of contact person	Toshikazu Moriwaki
Organization	University of Tsukuba
Division name	Division of Gastroenterology
Address	1-1-1, Tennodai, Tsukuba city, Ibaraki
TEL	029-853-3218
Homepage URL
Email	tmoriwak@md.tsukuba.ac.jp

Sponsor
Institute	Japanese Society for Cancer of the Colon and Rectum
Institute
Department

Funding Source
Organization	Japanese Society for Cancer of the Colon and Rectum
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	高知医療センター（高知県）、筑波大学（茨城県）、愛知県がんセンター（愛知県）、国立がん研究センター中央病院（東京都）、国立がん研究センター東病院（千葉健）、東京医科歯科大学（東京都）、静岡がんセンター（静岡県）、防衛医科大学校（埼玉県）、神戸大学（兵庫県）、九州大学（福岡県）、四国がんセンター（愛媛県）、九州がんセンター（福岡県）、千葉県がんセンター（千葉健）、北海道大学（北海道）、近畿大学（兵庫県）、埼玉県立がんセンター（埼玉県）、JHCO九州病院（福岡県）、大阪府立成人病センター（大阪府）、大阪大学（大阪府）

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 30 Day
Anticipated trial start date	2016 Year 01 Month 04 Day
Last follow-up date	2016 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete	2016 Year 12 Month 09 Day
Date analysis concluded	2016 Year 12 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://abstracts.asco.org/199/AbstView_199_182328.html
Results	Whether unadjusted analysis or adjusted analysis was established, regorafenib and trifluridine/tipiracil showed a similar efficacy in the overall survival of? patients with metastatic colorectal cancer refractory to standard treatments in the real-world setting.
Other related information	Retrospective observational study

Management information
Registered date	2016 Year 01 Month 02 Day
Last modified on	2018 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023578