UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045844 |
|---|---|
| Receipt number | R000052339 |
| Scientific Title | Multicenter retrospective study of chemotherapy for vulnerable patients with metastatic colorectal cancer |
| Date of disclosure of the study information | 2021/10/24 |
| Last modified on | 2023/02/03 02:16:36 |
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Basic information
Public title
Multicenter retrospective study of chemotherapy for vulnerable patients with metastatic colorectal cancer
Acronym
Retrospective study of vulnerable patients with metastatic colorectal cancer
Scientific Title
Multicenter retrospective study of chemotherapy for vulnerable patients with metastatic colorectal cancer
Scientific Title:Acronym
Retrospective study of vulnerable patients with metastatic colorectal cancer
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the effectiveness and safety of chemotherapy for patients with metastatic colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-free survival in second-line chemotherapy
Key secondary outcomes
Response rate, disease control rate, progression-free survival, time to treatment failure, and overall survival in first-line chemotherapy
Response rate, disease control rate, time to treatment failure, and overall survival in second-line chemotherapy
Overall survival in third-line chemotherapy
Reason for vulnerability
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) Histologically or cytologically diagnosed adenocarcinoma of the colon or rectum (excluding the appendix and anal canal)
2) Clinically unresectable
3) Underwent palliative chemotherapy between June 2015 and December 2018
4) Age of 20 or older
5) ECOG PS of 0-2
6) Inappropriate for intensive systemic therapy
Key exclusion criteria
Inappropriate for trial judged by medical doctors or principal investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hisato |
| Middle name | |
| Last name | Kawakami |
Organization
Kindai University faculty of medicine
Division name
Department of Medical Oncology
Zip code
589-8511
Address
377-2 Onohigashi, Osaka-sayama, Osaka
TEL
072-366-0221
kawakami_h@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Seiichiro |
| Middle name | |
| Last name | Mitani |
Organization
Kindai University faculty of medicine
Division name
Department of Medical Oncology
Zip code
589-8511
Address
377-2 Onohigashi, Osaka-sayama, Osaka
TEL
072-366-0221
Homepage URL
seiichiro.mitani@med.kindai.ac.jp
Sponsor or person
Institute
Ishikawa Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Ishikawa Prefectural Central Hospital
Address
2-1 Kuratukihigashi, Kanazawa, Ishikawa
Tel
076-237-8211
kitoyo9100@gmail.com
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
近畿大学病院
石川県立中央病院
九州大学病院
聖マリアンナ医科大学
神奈川県立がんセンター
四国がんセンター
名古屋医療センター
関西医科大学附属病院
筑波大学附属病院
恵佑会札幌病院
神戸市立医療センター中央市民病院
九州がんセンター
国立がん研究センター中央病院
大分大学医学部附属病院
岸和田市民病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 24 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 10 | Month | 24 | Day |
Last modified on
| 2023 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052339
