UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055681 |
|---|---|
| Receipt number | R000063599 |
| Scientific Title | Exploring prognostic factors and high-LET treatment-specific responses in high-LET heavy ion radiotherapy for bone and soft tissue sarcomas. |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2024/09/30 22:49:08 |
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Basic information
Public title
Exploring Prognostic Factors for Heavy Ion Therapy of Bone and Soft Tissue Sarcomas
Acronym
Exploring Prognostic Factors for Bone and Soft Tissue Sarcomas
Scientific Title
Exploring prognostic factors and high-LET treatment-specific responses in high-LET heavy ion radiotherapy for bone and soft tissue sarcomas.
Scientific Title:Acronym
Research on Heavy Ion Beam Therapy for Bone and Soft Tissue Sarcoma
Region
| Japan |
Condition
Condition
Bone and Soft Tissue Sarcoma
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore predictors of treatment efficacy and prognosis of high LET heavy ion radiotherapy for bone and soft tissue sarcomas, and to apply the results to improve treatment outcomes.
Basic objectives2
Others
Basic objectives -Others
Exploring predictors of treatment efficacy and prognosis of high LET heavy ion therapy for bone and soft tissue sarcomas
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Analysis of blood components using blood samples taken before the start of treatment, on the 11th day of treatment, and after the end of treatment on the last day of treatment. Whenever possible, the same analysis will be done during follow-up visits within 5 years of the end of treatment.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Adult patients (18 years of age or older) scheduled for heavy ion radiotherapy for bone and soft tissue sarcoma at QST Hospital. (Any treatment before or after the heavy ion radiotherapy is acceptable.)
2) Patients who have been fully informed about their participation in this study, fully understand the study, and have given appropriate written consent of their own free will.
Key exclusion criteria
Patients who are judged by the investigator or other physicians to be inappropriate to participate in this study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Shimokawa |
Organization
National Institutes for Quantum Science and Technology
Division name
Institute for Quantum Medical Science, Department of Accelerator and Medical Physics
Zip code
263-8555
Address
Anagawa4-9-1, Inage-ku, Chiba
TEL
043-206-4048
shimokawa.takashi@qst.go.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Imai |
Organization
National Institutes for Quantum Science and Technology
Division name
QST Hospital, Radiation Oncology Promotion Section
Zip code
263-8555
Address
Anagawa4-9-1, Inage-ku, Chiba
TEL
043-206-3306
Homepage URL
imai.reiko@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology
Institute
Department
Personal name
Shimokawa Takashi
Funding Source
Organization
National Institutes for Quantum Science and Technology
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
National Institute of Quantum Science and Technology
Address
Anagawa4-9-1, Inage-ku, Chiba, 283-8555, Japan
Tel
043-206-4706
helsinki@qst.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
| 2024 | Year | 10 | Month | 01 | 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 | 09 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2034 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood samples collected at the approved timing will be separated into plasma and cellular components, and their respective variation will be analyzed to examine their relationship to clinical efficacy.
Management information
Registered date
| 2024 | Year | 09 | Month | 30 | Day |
Last modified on
| 2024 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063599
