UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042473 |
|---|---|
| Receipt number | R000048486 |
| Scientific Title | Geriatric assessment and fact-finding survey of radiotherapy for elderly patients |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2025/07/22 13:39:05 |
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Basic information
Public title
Geriatric assessment and fact-finding survey of radiotherapy for elderly patients
Acronym
Geriatric assessment and fact-finding survey of radiotherapy for elderly patients
Scientific Title
Geriatric assessment and fact-finding survey of radiotherapy for elderly patients
Scientific Title:Acronym
Geriatric assessment and fact-finding survey of radiotherapy for elderly patients
Region
| Japan |
Condition
Condition
Head and neck cancer, lung cancer, esophageal cancer, breast cancer, pancreatic cancer, rectal cancer, bladder cancer, uterine cancer, and prostate cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the actual state of radiation therapy for elderly cancer patients and evaluate the usefulness of G-8 and VES-13
Basic objectives2
Others
Basic objectives -Others
To investigate the correlations between the actual state of radiotherapy (radiation therapy policies empirically selected by clinicians, radiation completion rates in those policies, incidence of acute adverse events of Grade 3 or higher, changes in QOL before and after radiotherapy) and geriatric assessment (G-8 and VES-13). Furthermore, to clarify the actual state of radiotherapy for elderly patients by evaluating the radiation completion rate, the incidence of acute adverse events of Grade 3 or higher, and changes in QOL (EORTC QLQ-C30) before and after irradiation.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between elderly function evaluation (G-8, VES-13) and changes in radiation therapy policy
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients are eligible for definitive radiation therapy as initial treatment, excluding patient background such as age and comorbidities
2.Patients received sufficient explanation before participating in this study, and obtained written consent by the patient himself / herself with sufficient understanding
Key exclusion criteria
1. Patient or his / her family cannot evaluate the patient's general condition, living condition, mental condition, etc
2. Patients with recurrent disease
3. Patients were judged by the principal investigator to be inappropriate as subjects
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Murofushi |
Organization
Tokyo Metropolitan Cancer and Infectious Center Komagome Hospital
Division name
Department of Radiology
Zip code
113-8677
Address
3-18-22, Honkomagome, Bunkyo-ku, Tokyo
TEL
03-3823-2101
kmurofushi0918@gmail.com
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Murofushi |
Organization
Tokyo Metropolitan Cancer and Infectious Center Komagome Hospital
Division name
Department of Radiology
Zip code
113-8677
Address
3-18-22, Honkomagome, Bunkyo-ku, Tokyo
TEL
03-3823-2101
Homepage URL
kmurofushi0918@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious Center Komagome 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
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Address
3-18-22, Honkomagome, Bunkyo-ku, Tokyo
Tel
03-3823-2101
km_rinri@tmhp.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
| 2020 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.1016/j.clon.2025.103894
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.clon.2025.103894
Number of participants that the trial has enrolled
320
Results
A multivariate analysis revealed that a reduction in radiation intensity was significantly associated with vulnerability assessed using the VES-13 score (P = 0.03) but not the G8 score (P = 0.63).(updated 7/22/2025)
Results date posted
| 2024 | Year | 03 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median patient age was 77 years (range: 70-90 years). The primary cancer sites were the head and neck and esophagus, lungs, breasts, pancreas, bladder, uterus, and prostate in 63 and 22, 62, 48, 6, 5, 26, and 85 patients, respectively.
Participant flow
Between November 2020 and February 2022, 320 patients were enrolled at 13 centres across Japan. Of these, three patients were excluded as two were diagnosed with metastatic rather than primary disease after study enrolment, and the other patient withdrew from the study, leading to a total of 317 patients for analysis.
Adverse events
Grade 3 or higher acute adverse events were collected.
Outcome measures
Geriatric assessment with the G8 did not predict reduction in radiation intensity or incompletion in older patients with cancer. Furthermore, our analysis prognostic factors associated with reduced radiotherapy intensity, encompassing vulnerability based on VES-13, poor nutrition based on the GNRI, a lower PS, and primary tumor types, such as head and neck cancer and esophageal cancer.
Plan to share IPD
none
IPD sharing Plan description
none
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients registration period: until December 31th, 2021
Management information
Registered date
| 2020 | Year | 11 | Month | 16 | Day |
Last modified on
| 2025 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048486
