UMIN-CTR Clinical Trial

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

Sponsor
Institute	Department of clinical oncology, Kawasaki Medical School
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018763