UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056052 |
|---|---|
| Receipt number | R000063956 |
| Scientific Title | Establishment of a prediction system for adverse events of chemoradiotherapy in older patients with head and neck, esophageal and lung cancer. |
| Date of disclosure of the study information | 2024/11/05 |
| Last modified on | 2024/11/05 14:49:39 |
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Basic information
Public title
Establishment of a prediction system for adverse events of chemoradiotherapy in older patients with head and neck, esophageal and lung cancer.
Acronym
Establishment of a prediction system for adverse events of chemoradiotherapy in older patients with head and neck, esophageal and lung cancer.
Scientific Title
Establishment of a prediction system for adverse events of chemoradiotherapy in older patients with head and neck, esophageal and lung cancer.
Scientific Title:Acronym
Establishment of a prediction system for adverse events of chemoradiotherapy in older patients with head and neck, esophageal and lung cancer.
Region
| Japan |
Condition
Condition
Head and neck cancer, Esophageal cancer, Lung cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Development of a prediction system for adverse events of chemoradiotherapy in older patients with head and neck, esophageal and lung cancer.
Basic objectives2
Others
Basic objectives -Others
Based on the results of risk factors for adverse events, including treatment intensity and geriatric assessment as predictors, a prediction system for adverse events from chemoradiotherapy in older patients with from fit to frail will be established.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Predict factors of grade 3 or higher acute adverse events
Key secondary outcomes
1. Change of treatment policy (radiotherapy and/or concurrent chemotherapy) and their predictors
2. Completion of planned radiotherapy and/or concurrent chemotherapy and their predictors
3. Rate of planned radiotherapy and/or concurrent chemotherapy not completed
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. Patients with difficulty returning to the hospital where they were treated for at least three months after treatment.
2. Patients with difficulty in maintaining the treatment position.
3. Patients with recurrent disease.
4. Patient or his / her family cannot evaluate the patient's Geriatric assessment.
5. Patients were judged by the principal investigator to be inappropriate as subjects.
Target sample size
300
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 Diseases 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 Komagome Hospital Ethics Review Board
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
がん・感染症センター都立駒込病院（東京都）/ Tokyo Metropolitan Cancer and Infectious Center Komagome Hospital
東京女子医科大学病院（東京都）/Tokyo Women’s Medical University Hospital
国際医療福祉大学成田病院（千葉県）/IUHW Narita Hospital
広島大学病院（広島県）/Hiroshima University Hospital
国立病院機構水戸医療センター（茨城県）/National Hospital Organization Mito Medical Center
九州大学病院（福岡県）/Kyushu University Hospital
神奈川県立がんセンター（神奈川県）/Kanagawa Cancer Center
北海道大学病院（北海道）/Hokkaido University Hospital
昭和大学病院（東京都）/SHOWA University Hospital
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 05 | 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
| 2024 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-Prospective, observational study
-Geriatric assessments are carried out on study subjects prior to the start of radiotherapy.
-Patients registration period : September 30, 2026 (planned)
Management information
Registered date
| 2024 | Year | 11 | Month | 05 | Day |
Last modified on
| 2024 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063956
