UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060696 |
|---|---|
| Receipt number | R000069426 |
| Scientific Title | A prospective observational study on setup accuracy and patient preferences in radiotherapy under clothing |
| Date of disclosure of the study information | 2026/02/17 |
| Last modified on | 2026/02/17 14:12:08 |
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Basic information
Public title
A study to evaluate setup accuracy and patient preferences for radiotherapy performed under clothing
Acronym
Radiotherapy-under-Clothing Study
Scientific Title
A prospective observational study on setup accuracy and patient preferences in radiotherapy under clothing
Scientific Title:Acronym
Radiotherapy-under-Clothing Study
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to prospectively evaluate the setup accuracy of markerless radiotherapy under clothing using surface-guided radiation therapy (SGRT), and to assess patient preferences for radiotherapy performed under clothing.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether the three-dimensional (3D) vector length of the setup correction determined by image guidance during radiotherapy under clothing is within the clinically acceptable threshold of 5 mm at our institution.
Key secondary outcomes
Patient preferences for radiotherapy under clothing, assessed by the proportion of patients who choose radiotherapy under clothing and by questionnaire-based evaluations.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
In this study, wearing clothing during radiotherapy is defined as the intervention. All radiotherapy delivery and image-guided procedures are conducted within the scope of routine clinical practice. Treatment dose, irradiation technique, and image guidance frequency are not modified from standard procedures.
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
1) Patients with breast cancer scheduled to receive radiotherapy (whole-breast irradiation or accelerated partial breast irradiation) at our institution
2) Patients aged 20 years or older at the start of radiotherapy
3) Patients who have provided written informed consent to participate in this study
Key exclusion criteria
1) Patients who decline to participate in this study or withdraw consent
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Ryohei |
| Middle name | |
| Last name | Yamauchi |
Organization
St. Luke's International Hospital
Division name
Department of Radiation Oncology
Zip code
104-8560
Address
9-1, Akashi-cho, Chuo-ku Tokyo
TEL
03-3541-5151
yamaryo@luke.ac.jp
Public contact
Name of contact person
| 1st name | Ryohei |
| Middle name | |
| Last name | Yamauchi |
Organization
St. Luke's International Hospital
Division name
Department of Radiation Oncology
Zip code
1048560
Address
9-1, Akashi-cho, Chuo-ku Tokyo
TEL
03-3541-5151
Homepage URL
yamaryo@luke.ac.jp
Sponsor or person
Institute
St. Luke's International 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
St. Luke's International Hospital
Address
9-1 Akashi-cho, Chuo-ku, Tokyo
Tel
03-3541-5151
yamaryo@luke.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
| 2026 | Year | 02 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | 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
Management information
Registered date
| 2026 | Year | 02 | Month | 17 | Day |
Last modified on
| 2026 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069426
