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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000042473 |
Receipt No. | 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 | 2020/11/16 |
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 |
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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 |
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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 | |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 500 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
murofushi@pmrc.tsukuba.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |