UMIN-CTR Clinical Trial

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
Email	murofushi@pmrc.tsukuba.ac.jp

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
Email	murofushi@pmrc.tsukuba.ac.jp

Sponsor
Institute	Tokyo Metropolitan Cancer and Infectious Center Komagome Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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
Email	murofushi@pmrc.tsukuba.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	2623
Org. issuing International ID_1	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
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
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	Enrolling by invitation
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	2023 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Patients registration period: until June 30th, 2021

Management information
Registered date	2020 Year 11 Month 16 Day
Last modified on	2021 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048486

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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