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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036690
Receipt No. R000041811
Scientific Title C" Study
Date of disclosure of the study information 2019/05/10
Last modified on 2019/05/20

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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
Email 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
Email takeshin@med.kawasaki-m.ac.jp

Sponsor
Institute Department of Clinical Oncology, Kawasaki MEdical School
JSWOG
Institute
Department

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
Email 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
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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 10 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2019 Year 05 Month 09 Day
Last modified on
2019 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041811

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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