UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014664
Receipt No. R000017057
Scientific Title A phase II study comparing oral S-1 + 24-hour infusion of CPT-11 +bevacizumab with FOLFIRI+bevacizumab for metastatic colorectal cancer
Date of disclosure of the study information 2014/07/28
Last modified on 2018/07/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A phase II study comparing oral S-1 + 24-hour infusion of CPT-11 +bevacizumab with FOLFIRI+bevacizumab for metastatic colorectal cancer
Acronym A phase II study comparing oral S-1 + 24-hour infusion of CPT-11 +bevacizumab with FOLFIRI+bevacizumab
Scientific Title A phase II study comparing oral S-1 + 24-hour infusion of CPT-11 +bevacizumab with FOLFIRI+bevacizumab for metastatic colorectal cancer
Scientific Title:Acronym 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
Last name of lead principal investigator
1st name
Middle name
Last name Sotaro Sadahiro
Organization Tokai University
Division name Deaprtment of Gastrointestinal Surgery
Zip code
Address 143 Shimokasuya Isehara
TEL 0463-93-1121
Email sadahiro@is.icc.u-tokai.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Sotaro Sadahiro
Organization Tokai Unversity
Division name Department of Gastrointestinal Surgery
Zip code
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)

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 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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 Completed
Date of protocol fixation
2013 Year 09 Month 18 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000017057

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.