UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050894 |
|---|---|
| Receipt number | R000051531 |
| Scientific Title | Histological evaluation of colorectal liver metatases with or without chemotherapy |
| Date of disclosure of the study information | 2023/04/20 |
| Last modified on | 2024/04/20 13:37:54 |
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Basic information
Public title
Histological evaluation of colorectal liver metatases with or without chemotherapy
Acronym
Histological effect of chemotherapy on colorectal liver metastases
Scientific Title
Histological evaluation of colorectal liver metatases with or without chemotherapy
Scientific Title:Acronym
Histological effect of chemotherapy on colorectal liver metastases
Region
| Japan |
Condition
Condition
Colorectal liver metastases
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the histological influence of chemotherapy on K-ras wild colorectal liver metastases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of micrometatases around colorectal liver metastases
Key secondary outcomes
Distance from colorectal liver metastases to micrometatases
Thickness of pseudocapsule around colorectal liver metastases
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
The patients who enrolled a multicenter randomized phase III trial to compare surgery followed by postoperative FOLFOX regimen with perioperative FOLFOX regimen plus cetuximab in patients with KRAS wild-type resectable colorectal liver metastases
Key exclusion criteria
The patients who declined.
The patients who were judged unsuitable for the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Hasegawa |
Organization
Tokyo university
Division name
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
kihase-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Matsumura |
Organization
Tokyo university
Division name
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
team-ma22n@hotmail.co.jp
Sponsor or person
Institute
Tokyo university
Institute
Department
Personal name
Hasegawa Kiyoshi
Funding Source
Organization
Tokyo university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Translational research center of medical innovation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo university
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-3815-5411
ethics@m.u-tokyo.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
東京大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
31
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 | 06 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the frequency of micrometastases and distance from tumor to micrometastases by HE stained specimen.
Management information
Registered date
| 2023 | Year | 04 | Month | 20 | Day |
Last modified on
| 2024 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051531
| Research Plan | |
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| 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 |
