UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016165 |
|---|---|
| Receipt number | R000018763 |
| Scientific Title | An exploratory study to evaluate molecular predictive and/or prognostic factors of benefit from a 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. |
| Date of disclosure of the study information | 2015/01/09 |
| Last modified on | 2021/04/09 09:28:36 |
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Basic information
Public title
An exploratory study to evaluate molecular predictive and/or prognostic factors of benefit from a 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-Prime Study
Scientific Title
An exploratory study to evaluate molecular predictive and/or prognostic factors of benefit from a 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.
Scientific Title:Acronym
C-Prime Study
Region
| Japan |
Condition
Condition
Unresectable advanced colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study is desgined as an exploratory phase II study to evaluate molecular predictive and/or prognostic factors of benefit from a 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.
Basic objectives2
Others
Basic objectives -Others
Correlation between image evaluation/clinical data and molecular predictive and/or prognostic factors including genetic and epigenetic alterations derived from colorectal cancer tissues
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Correlation between image evaluation/clinical data and molecular predictive and/or prognostic factors including genetic and epigenetic alterations derived from colorectal cancer tissues
Key secondary outcomes
1) Correlation between prognostic factors including genetic and epigenetic alterations derived from colorectal cancer tissues and the evaluation criteria about efficacy/safety; ORR (Overall response rate), PFS (Progression free-survival), DDC (Duration of disease control), TTF (Time to treatment-failure), OS (Overall survival), Safety, and QoL (Quality of Life),
2) Relevance between evaluations of the C-Cubed study and molecular predictive and/or prognostic factors including genetic and epigenetic alterations derived from colorectal cancer tissues.
3) Relevance between each molecular predictive and/or prognostic factors including genetic and epigenetic alterations derived from colorectal cancer tissues.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Participating the C-Cubed study with written informed consent.
2) Written informed consent after receiving explanation of planned treatments in the study.
Key exclusion criteria
None
Target sample size
304
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | O |
| Last name | Nagasaka |
Organization
Kawasaki Medical School
Division name
Department of Clinical Oncology
Zip code
701-0192
Address
Matsushima
TEL
0864621111
takeshin@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 Gastroenterological Surgery
Zip code
701-0192
Address
577, Matsushima, Kurashiki
TEL
086-462-1111
Homepage URL
takeshin@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of clinical oncology, Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Department of clinical oncology, Kawasaki Medical School
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
Kawasaki Medical School
Address
577, Matsushima. Kurashiki city, Okayama
Tel
086-462-1111
takeshin@med.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
| 2015 | Year | 01 | Month | 09 | 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
132
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
now ongoing
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
| 2014 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 10 | Day |
Date trial data considered complete
| 2022 | Year | 01 | Month | 10 | Day |
Date analysis concluded
| 2022 | Year | 01 | Month | 10 | Day |
Other
Other related information
This study is desgined as an exploratory phase II study to evaluate molecular predictive and/or prognostic factors of benefit from a 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.
Management information
Registered date
| 2015 | Year | 01 | Month | 09 | Day |
Last modified on
| 2021 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018763
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