UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056550 |
|---|---|
| Receipt number | R000064411 |
| Scientific Title | Prospective observational study of diagnostic CT-based radiation therapy |
| Date of disclosure of the study information | 2024/12/24 |
| Last modified on | 2026/03/17 15:31:50 |
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Basic information
Public title
Prospective observational study of diagnostic CT-based radiation therapy
Acronym
D-CART
Scientific Title
Prospective observational study of diagnostic CT-based radiation therapy
Scientific Title:Acronym
D-CART
Region
| Japan |
Condition
Condition
malignant disease
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In a prospective interventional study, we confirmed that palliative radiotherapy using diagnostic-CT images instead of radiotherapy-planning-CT images (Simulation-free Radiation Therapy; SFRT) can be safely performed, and can greatly shorten the time to start radiotherapy. However, since this method has not yet been widely adopted in clinical practice, we aim to prospectively evaluate the number of patients treated by this method in actual clinical practice, as well as the outcomes and safety of this treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
completion rate of SFRT
Key secondary outcomes
TIC (time in center) (defined as time spent in radiotherapy department)
Pain complete response rate and pain response rate at 4, 12 and 24 weeks
Adverse event rate
Re-irradiation rate
Overall survival
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Agreement of recieving radiotherapy
(2) Bone metastases identifiable by diagnostic CT
(3) Not wearing a corset or other external body equipment at the time of the CT
(4) Patient is able to lie in supine position at rest
Key exclusion criteria
(1) Undetectable bone metastasis on the CT
(2) Missing tissue of the CT if it was in the beam path
(3) Pregnant
(4) Severe mentally retarded
Target sample size
40
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 24 | 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
40
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Time in centre (TIC), i.e. time spent in the radiotherapy department (from the start of the consultation to the end of the first radiotherapy beam), is measured at the first irradiation.
Follow-up is conducted at 4, 12 and 24 weeks and the rate of adverse event occurrence is assessed according to CTCAE ver. 5.0. In patients treated with palliative radiotherapy for cancer pain, the pain response rate and pain complete response rate will be assessed based on the Numerical Rating Scale (NRS) and International Consensus Pain Response Endpoints (ICPRE). After 24 weeks, follow-up every 3-6 months is recommended. However, given that most patients in this study will have distant metastases, follow-up visits may be a significant burden for patients, so the need for follow-up and intervals will be considered on a case-by-case basis.
Other information to be collected at enrolment includes gender, age, general condition (ECOG Performance Status), pathological or clinical diagnosis and clinical stage.
Management information
Registered date
| 2024 | Year | 12 | Month | 24 | Day |
Last modified on
| 2026 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064411
