UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014664 |
|---|---|
| Receipt number | 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 12:03:26 |
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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
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
sadahiro@is.icc.u-tokai.ac.jp
Public contact
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
sadahiro@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University, Deaprtment of Gastrointestinal Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017057
