UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036690 |
|---|---|
| Receipt number | R000041811 |
| Scientific Title | C" Study |
| Date of disclosure of the study information | 2019/05/10 |
| Last modified on | 2024/05/13 11:23:49 |
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Basic information
Public title
An observational study to follow clinical outcomes for the patients participated in the randomized, phase III trial of sequential capecitabine/5FU plus bevacizumab (Cape/5FU-Bmab) to capecitabine/5FU plus oxaliplatin plus bevacizumab (CapeOX/mFOLOFX6-Bmab) versus combination CapeOX/mFOLFOX6-Bmab in advanced colorectal cancer
Acronym
C" Study
Scientific Title
C" Study
Scientific Title:Acronym
C" Study
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Follow the prognosis of C-cubed study participants.
Collect RAS and BRAF gene mutation spectrum information.
Basic objectives2
Others
Basic objectives -Others
Among the participating patients in C-cubed Study, we are planing to collect tumor tissues and analyze cancer-related genetic, epigenetic and immunological alterations by using DNA, RNA and IHC.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Final update of OS in C-cubed study.
Determination of patient population to RAS/BRAF mutations.
Key secondary outcomes
Among the participating patients in C-cubed Study, we are planing to collect tumor tissues and analyze cancer-related genetic, epigenetic and immunological altelations by using DNA/RNA and IHC.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients wwho paticipated in the C- cubed study/
Key exclusion criteria
none
Target sample size
311
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki Yamaguchi |
| Middle name | |
| Last name | Masasumi Okajima |
Organization
Kawasaki medical school/JSWOG
Division name
Department of Clinical Oncology
Zip code
701-0192
Address
577 Matsushima, Kurashiki
TEL
0864621111
shogo@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Nagasaka |
Organization
Kawasaki Medical School
Division name
Department of Clinical Oncology
Zip code
701-0192
Address
577 Matsushima, Kurashiki
TEL
0864621111
Homepage URL
takeshin@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Clinical Oncology, Kawasaki MEdical School
JSWOG
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School
Address
577 Matsushima, Kurashiki
Tel
086-462-1111
rinri@hp.kawasaki-m.ac.jp
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
| 2019 | Year | 05 | Month | 10 | 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
452
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Under analyze
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 05 | Month | 09 | Day |
Last modified on
| 2024 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041811
