UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050148 |
|---|---|
| Receipt number | R000056820 |
| Scientific Title | Observational Study on the long term prognosis in A Multicenter Phase II Clinical Study Evaluating the Efficacy and Safety of Neoadjuvant and Adjuvant Chemotherapy with Encorafenib, Binimetinib Plus Cetuximab in Patients with Surgically Resectable BRAF V600E Mutant Colorectal Metastasis |
| Date of disclosure of the study information | 2023/01/27 |
| Last modified on | 2024/01/29 13:37:45 |
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Basic information
Public title
Observational Study on the long term prognosis in A Multicenter Phase II Clinical Study Evaluating the Efficacy and Safety of Neoadjuvant and Adjuvant Chemotherapy with Encorafenib, Binimetinib Plus Cetuximab in Patients with Surgically Resectable BRAF V600E Mutant Colorectal Metastasis
Acronym
Observational Study in NEXUS Study
Scientific Title
Observational Study on the long term prognosis in A Multicenter Phase II Clinical Study Evaluating the Efficacy and Safety of Neoadjuvant and Adjuvant Chemotherapy with Encorafenib, Binimetinib Plus Cetuximab in Patients with Surgically Resectable BRAF V600E Mutant Colorectal Metastasis
Scientific Title:Acronym
Observational Study in NEXUS Study
Region
| Japan |
Condition
Condition
Patients with surgically resectable BRAF V600E mutant colorectal metastasis.
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose is to analyze the long-term prognosis after the end of the observation period of the NEXUS study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Progression free survival
Disease-free survival
Incidence of adverse events
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
Patients with resectable metastatic colorectal cancer with BRAF V600E mutation who were enrolled in the NEXUS study and consented to the secondary use of information obtained in the NEXUS study and consented to participate in the NEXUS study-observational study.
Key exclusion criteria
Patients whose consent has not been withdrawn will be included.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Yoshino |
Organization
National Cancer Center Hospital East
Division name
Department of Gastrointestinal Oncology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
0471331111
nexus_core@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | kobayashi |
Organization
National Cancer Center Hospital East
Division name
Department of Hepatobiliary and Pancreatic Surgery
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
0471331111
Homepage URL
ymikamot@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Research Ethics Review Committee
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
Tel
04-7133-1111
NCC_IRBoffice@ml.res.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The design of this study is a multicenter prospective cohort study, using only the secondary use of existing information obtained in routine practice after the observation period of the NEXUS study and the registry data of the NEXUS study-TR study. The observation period is from the day following the end of the observation period of the NEXUS study to the same day 5 years after the last case registration date of the NEXUS study, and the existing information on long-term prognosis and safety of NEXUS study enrollment cases during the above period is collected.
Management information
Registered date
| 2023 | Year | 01 | Month | 26 | Day |
Last modified on
| 2024 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056820
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
