UMIN-CTR Clinical Trial

Basic information
Public title	TR study of "A multicenter phase II study of eribulin monotherapy in patients with BRAF V600E mutant metastatic colorectal cancer (BRAVERY study)"
Acronym	BRAVERY TR
Scientific Title	TR study of "A multicenter phase II study of eribulin monotherapy in patients with BRAF V600E mutant metastatic colorectal cancer (BRAVERY study)"
Scientific Title:Acronym	BRAVERY TR
Region	Japan

Condition
Condition	BRAF V600E mutant metastatic colorectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To explore biomarker relating to efficacy or resistance of eribulin in patients with BRAF V600E mutant metastatic colorectal cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	cancer-related gene alteration, gene expression, microsatellite instability, BRAF mutant allele frequency
Key secondary outcomes

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) Enrolled in the BRAVERY study 2) Written informed consent
Key exclusion criteria	None
Target sample size	42

Research contact person
Name of lead principal investigator	1st name Hiroya Middle name Last name Taniguchi
Organization	National Cancer Center Hospital East
Division name	Department of GI Oncology
Zip code	277-8577
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL	04-7133-1111
Email	BRAVERY_core@east.ncc.go.jp

Public contact
Name of contact person	1st name Toshiki Middle name Last name Masuishi
Organization	Aichi Cancer Center Hospital
Division name	Department of Clinical Oncology
Zip code	464-8681
Address	1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan
TEL	052-764-6111
Homepage URL
Email	BRAVERY_core@east.ncc.go.jp

Sponsor
Institute	Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization	Self funding
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	National Cancer Center Hospital Institutional Review Board
Address	Tsukiji 5-1-1, Chuo-ku, Tokyo
Tel	04-7133-1111
Email	irboffice@east.ncc.go.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	愛知県がんセンター(愛知県)、国立がん研究センター東病院（千葉県）、九州がんセンター(福岡県)、四国がんセンター(愛媛県)、北海道大学病院(北海道)、聖マリアンナ医科大学病院(神奈川県)、がん研究会有明病院（東京都）、大阪大学医学部附属病院（大阪府）

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 26 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	27
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	No longer recruiting
Date of protocol fixation	2018 Year 01 Month 10 Day
Date of IRB	2018 Year 04 Month 04 Day
Anticipated trial start date	2018 Year 04 Month 04 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is the additional study in UMIN ID:UMIN000031221.

Management information
Registered date	2018 Year 03 Month 02 Day
Last modified on	2020 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035492

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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