UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study comparing oral S-1 + 24-hour infusion of CPT-11 +bevacizumab with FOLFIRI+bevacizumab for metastatic colorectal cancer
Title of the study (Brief title)	A phase II study comparing oral S-1 + 24-hour infusion of CPT-11 +bevacizumab with FOLFIRI+bevacizumab
Region	Japan

Condition
Condition	metastatic colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to investigate the efficacy of oral S-1+24-hour infusion of CPT-11+bevacizumab and FOLFIRI+bevacizumab for metastatic colorectal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	1 year progression-free survival
Key secondary outcomes	time to progression response rate overall survival adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	standard therapy group (FOLFIRI+bevacizumab)
Interventions/Control_2	trial therapy arm (Oral S-1+24-hour infusion of CPT-11+bevacizumab)
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	metastatic colorectal cancer
Key exclusion criteria	performance status is 2 or 3
Target sample size	100

Research contact person
Name of lead principal investigator	Sotaro Sadahiro
Organization	Tokai University
Division name	Deaprtment of Gastrointestinal Surgery
Address	143 Shimokasuya Isehara
TEL	0463-93-1121
Email	sadahiro@is.icc.u-tokai.ac.jp

Public contact
Name of contact person	Sotaro Sadahiro
Organization	Tokai Unversity
Division name	Department of Gastrointestinal Surgery
Address	143 Shimokasuya Isehara
TEL	0463-93-1121
Homepage URL
Email	sadahiro@is.icc.u-tokai.ac.jp

Sponsor
Institute	Tokai University, Deaprtment of Gastrointestinal Surgery
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	東海大学医学部付属病院

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 18 Day
Anticipated trial start date	2013 Year 12 Month 01 Day
Last follow-up date	2017 Year 09 Month 30 Day
Date of closure to data entry	2017 Year 09 Month 30 Day
Date trial data considered complete	2017 Year 09 Month 30 Day
Date analysis concluded	2018 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 07 Month 27 Day
Last modified on	2018 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017057