UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058483 |
|---|---|
| Receipt number | R000066712 |
| Scientific Title | A single-arm study evaluating the treatment planning quality of palliative radiotherapy using diagnostic CT for rapid initiation |
| Date of disclosure of the study information | 2025/07/15 |
| Last modified on | 2025/07/16 00:03:38 |
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Basic information
Public title
A single-arm study evaluating the treatment planning quality of palliative radiotherapy using diagnostic CT for rapid initiation
Acronym
A single-arm study evaluating the treatment planning quality of palliative radiotherapy using diagnostic CT for rapid initiation
Scientific Title
A single-arm study evaluating the treatment planning quality of palliative radiotherapy using diagnostic CT for rapid initiation
Scientific Title:Acronym
A single-arm study evaluating the treatment planning quality of palliative radiotherapy using diagnostic CT for rapid initiation
Region
| Japan |
Condition
Condition
Palliative radiotherapy
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study includes patients undergoing palliative radiotherapy and aims to expedite the initiation of treatment by using diagnostic CT instead of conventional planning CT for treatment planning. The objective is to demonstrate that treatment planning based on diagnostic CT is non-inferior to that using conventional planning CT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The percentage of radiotherapy treatments achieving acceptable dose delivery
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
Palliative radiotherapy
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to receive palliative radiotherapy
Performance status (PS) : 0-3
Lesions eligible for palliative radiotherapy confirmed by CT or MRI
Availability of a CT scan obtained within the past 3 months that includes the planned irradiation site
Written informed consent obtained
Key exclusion criteria
Inability to maintain the required position for radiotherapy
Significant changes in condition compared to the diagnostic CT
Deemed inappropriate for the study by the investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Igaki |
Organization
National Cancer Center Hospital, Japan
Division name
Department of Radiation Oncology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
hirigaki@ncc.go.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Inaba |
Organization
National Cancer Center Hospital, Japan
Division name
Department of Radiation Oncology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
koinaba@ncc.go.jp
Sponsor or person
Institute
National Cancer Center, Japan
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
National Cancer Center Institutional Review Board
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
Tel
0335422511
NCC_IRBoffice@ml.res.ncc.go.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
| 2025 | Year | 07 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2027 | Year | 05 | 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
| 2025 | Year | 07 | Month | 15 | Day |
Last modified on
| 2025 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066712
