UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060489 |
|---|---|
| Receipt number | R000069198 |
| Scientific Title | Geriatric Assessment-Based Stratification to Evaluate Treatment Intensity, Quality of Life, and Survival in Older Patients with Metastatic Colorectal Cancer: Protocol for a Prospective Observational Study |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/01/28 17:58:28 |
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Basic information
Public title
Geriatric Assessment-Based Stratification to Evaluate Treatment Intensity, Quality of Life, and Survival in Older Patients with Metastatic Colorectal Cancer: Protocol for a Prospective Observational Study
Acronym
Geriatric Assessment in Older Patients With Colorectal Cancer
Scientific Title
Geriatric Assessment-Based Stratification to Evaluate Treatment Intensity, Quality of Life, and Survival in Older Patients with Metastatic Colorectal Cancer: Protocol for a Prospective Observational Study
Scientific Title:Acronym
Geriatric Assessment in Older Patients With Colorectal Cancer
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastroenterology | Geriatrics | Gastrointestinal surgery |
| Nursing |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study aims to prospectively evaluate the associations among baseline geriatric assessment (GA) domains, treatment intensity, overall survival (OS), and QOL in older patients with mCRC receiving first-line systemic therapy in routine clinical practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall Survival
Key secondary outcomes
Time to Treatment Failure (TTF)
Incidence of grade 3 or more adverse events
Hospitalization rate and length of hospital stay
Treatment discontinuation rate
Relative dose intensity (RDI)
Quality of life (QOL) scores assessed using the EORTC QLQ-C30
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible patients are aged 70 years or older, have histologically confirmed metastatic or recurrent colorectal cancer, and are initiating first-line systemic therapy. Written informed consent is obtained from all participants.
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Hiramatsu |
Organization
Kawasaki Medical School Hospital
Division name
Department of Nursing
Zip code
700-0914
Address
Matsushima 577, Kurashiki-city, Okayama
TEL
0864621111
thiramatsu@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Nagasaka |
Organization
Kawasaki Medical School Hospital
Division name
Clinical Oncology
Zip code
700-0914
Address
Matsushima 577, Kurashiki-city, Okayama
TEL
0864621111
Homepage URL
takeshin@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
Kawasaki Medical School
Address
Matsushima 577, Kurashiki-city, Okayama
Tel
0864621111
kmsrec@med.kawasaki-m.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
Okayama
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | 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
None.
Management information
Registered date
| 2026 | Year | 01 | Month | 27 | Day |
Last modified on
| 2026 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069198
