UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054077 |
|---|---|
| Receipt number | R000061751 |
| Scientific Title | A prospective observational study of ultra-hypofractionated radiotherapy for postoperative breast cancer patients |
| Date of disclosure of the study information | 2024/04/05 |
| Last modified on | 2024/04/05 23:43:50 |
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Basic information
Public title
A prospective observational study of ultra-hypofractionated radiotherapy for postoperative breast cancer patients
Acronym
A prospective observational study of ultra-hypofractionated radiotherapy for postoperative breast cancer patients
Scientific Title
A prospective observational study of ultra-hypofractionated radiotherapy for postoperative breast cancer patients
Scientific Title:Acronym
A prospective observational study of ultra-hypofractionated radiotherapy for postoperative breast cancer patients
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm that ultra-short-term irradiation after breast-conserving surgery is safe and effective in Japanese patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events at 1, 3, and 6 months after the start of radiation therapy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients must be at least 20 years old at the time of consent (no upper age limit).
Patients scheduled for postoperative irradiation as breast-conserving therapy.
Patients who have been thoroughly informed about their participation in this study and have provided written consent of their own free will based on adequate understanding.
Key exclusion criteria
Patients with infections that require systemic treatment.
Pregnant, possibly pregnant, or lactating patients.
Patients who have previously received chest radiation therapy.
Patients are scheduled for concurrent chemotherapy.
Patients with diabetes mellitus who are being treated with continuous insulin injections or are poorly controlled.
Patients diagnosed with interstitial pneumonia, pulmonary fibrosis, or severe emphysema.
Patients receive continuous systemic administration (oral or intravenous) of steroids.
Patients receiving immunosuppressive agents for active collagen disease
Patients with severe cardiac disease or heart failure.
Patients who are deemed ineligible for participation in this study by the principal investigator or principal investigator-designated physicians.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Okonogi |
Organization
Juntendo University
Division name
Department of Radiation Oncology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5802-1230
n.okonogi.rd@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Okonogi |
Organization
Juntendo University
Division name
Department of Radiation Oncology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5802-1230
Homepage URL
n.okonogi.rd@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
Medical Research Ethics Committee, Juntendo University
Address
Hongo, Bunkyo-ku, Tokyo 1-3
Tel
03-3813-3111
n.okonogi.rd@juntendo.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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | 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 | 02 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After obtaining consent, radiotherapy will be administered according to the regulations, and adverse events will be evaluated at 1, 3, and 6 months after the start of treatment.
Management information
Registered date
| 2024 | Year | 04 | Month | 05 | Day |
Last modified on
| 2024 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061751
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
