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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000031552 |
Receipt No. | R000035492 |
Scientific Title | TR study of "A multicenter phase II study of eribulin monotherapy in patients with BRAF V600E mutant metastatic colorectal cancer (BRAVERY study)" |
Date of disclosure of the study information | 2018/03/26 |
Last modified on | 2020/08/17 |
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 |
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Condition | |||
Condition | BRAF V600E mutant metastatic colorectal cancer | ||
Classification by specialty |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Enrolled in the BRAVERY study
2) Written informed consent |
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Key exclusion criteria | None | |||
Target sample size | 42 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
BRAVERY_core@east.ncc.go.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |