UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054721 |
|---|---|
| Receipt number | R000062161 |
| Scientific Title | Feasibility study of diagnostic CT-based palliative radiation therapy |
| Date of disclosure of the study information | 2024/06/20 |
| Last modified on | 2025/06/20 09:16:14 |
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Basic information
Public title
Feasibility study of diagnostic CT-based palliative radiation therapy
Acronym
D-CART
Scientific Title
Feasibility study of diagnostic CT-based palliative radiation therapy
Scientific Title:Acronym
D-CART
Region
| Japan |
Condition
Condition
bone metastasis
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of palliative radiation therapy using a radiation treatment plan created based on diagnostic CT instead of CT simulation, and its efficacy and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Completion rate of diagnostic CT-based radiation therapy
Key secondary outcomes
Time in radiation therapy center (TIC)
Pain complete response rate and pain response rate at 4 and 12 weeks
Adverse event incidence rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Palliative radiation therapy based on diagnostic CT, delivering 8 Gy in single fraction.
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
(1) Agreement of recieving palliative radiotherapy for vertebral bone metastases
(2) Bone metastases identifiable by diagnostic CT performed at our institution within 56 days prior to the date of enrollment in the study
(3) Not wearing a corset or other external body equipment at the time of the CT
(4) One posterior field or 2 anterior and posterior fields delivering 8 Gy in single fraction is considered sufficient to treat the vertebra
(5) Patient is able to lie in supine position at rest
(6) Written informed consent to participate in the study
(7) Age 18 years or older
Key exclusion criteria
(1) Undetectable bone metastasis on the CT
(2) Missing tissue of the CT if it was in the beam path
(3) Substantial overlap with a previously treated radiation volume
(4) Contraindication of radiation therapy to the area to be treated
(5) Pregnant
(6) Severe mentally retarded
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Shuji |
| Middle name | |
| Last name | Ohtsu |
Organization
Kyoto city hospital
Division name
Department of radiation oncology
Zip code
604-8845
Address
1-2 Mibuhigashitakadacho, Nakagyo Ward, Kyoto city, Kyoto, 604-8845, Japan
TEL
075-311-5311
so2.kch@gmail.com
Public contact
Name of contact person
| 1st name | Kiyonao |
| Middle name | |
| Last name | Nakamura |
Organization
Kyoto city hospital
Division name
Department of radiation oncology
Zip code
604-8845
Address
1-2 Mibuhigashitakadacho, Nakagyo Ward, Kyoto city, Kyoto, 604-8845, Japan
TEL
075-311-5311
Homepage URL
kiyonaka@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto city hospital
Institute
Department
Personal name
Shuji Ohtsu
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
Kyoto city hospital
Address
1-2 Mibuhigashitakadacho, Nakagyo Ward, Kyoto city, Kyoto, 604-8845, Japan
Tel
075-311-5311
kiyonaka@kuhp.kyoto-u.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
京都市立病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.thegreenjournal.com/article/S0167-8140(25)04308-7/abstract
Number of participants that the trial has enrolled
5
Results
We started the trial in June 2024 and reached the target number of five cases in September. In all cases, radiotherapy planning using dCT was possible and irradiation was performed. The primary endpoint, the radiotherapy completion rate, was 100%.
The secondary endpoint, TIC, averaged 45 minutes and the rate of Grade 2 or higher acute adverse events was 0%.
Results date posted
| 2024 | Year | 12 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
The rate of Grade 2 or higher acute adverse events was 0%.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2024 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 20 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 20 | Day |
Last modified on
| 2025 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062161
