UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052664 |
|---|---|
| Receipt number | R000060097 |
| Scientific Title | Evaluation of the usefulness of proton therapy for intracranial tumors using a model-based approach |
| Date of disclosure of the study information | 2023/10/31 |
| Last modified on | 2024/10/31 10:00:36 |
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Basic information
Public title
Multi-institutional study to evaluate the usefulness of proton therapy for intracranial tumors using normal tissue complication probability model
Acronym
MBAPT-CNS trial
Scientific Title
Evaluation of the usefulness of proton therapy for intracranial tumors using a model-based approach
Scientific Title:Acronym
MBAPT-CNS trial
Region
| Japan |
Condition
Condition
Glioma, Meningioma
Classification by specialty
| Radiology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the usefulness of proton therapy by comparing proton beam treatment plan with virtual X-ray treatment plan (intensity modulated radiation therapy, created in Hokkaido university hospital).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Model based normal tissue complication probability (NTCP) (alopecia, hearing inmairment, tinnitus, cognitive disorder, blindness, cataract, brain necrosis, endocrine dysfunction, second malignancy)
Key secondary outcomes
1. Search for indicators that indicate the validity of plan comparison in planning studies
2. Search for indicators to select patients for whom proton beam therapy is desirable
3. Comparison of actual probability of adverse event occurrence and predicted NTCP (performance evaluation of NTCP model)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Among patients with glioma and meningioma who were registered in the proton beam registry database, radiation therapy was started between May 1, 2016 and April 30, 2021, and treatment plan data could be submitted in DICOM format. A person who is capable of outputting information and who has not received a refusal to participate in this research from a research subject or a person who is considered to be able to represent the wishes and interests of the research subject.
Key exclusion criteria
1. Persons of nationality other than Japan
2. Persons who underwent hyperfractionated irradiation (irradiation twice a day)
3. Persons who received proton beam therapy as private practice
4. Persons who have undergone proton beam therapy to areas with a history of radiation therapy
5. Other persons deemed unsuitable as research subjects by the research director
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hidefumi |
| Middle name | |
| Last name | Aoyama |
Organization
Hokkaido university
Division name
Department of radiation oncology
Zip code
060-8638
Address
Kita 15, Nishi 7, Kita ku, Sapporo, Hokkaido
TEL
011-706-5977
ro-inquiry@ml.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Nishioka |
Organization
Hokkaido university
Division name
Global Center for Biomedical Science and Engineering
Zip code
060-8638
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido
TEL
011-706-7798
Homepage URL
k.nishioka@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido university
Institute
Department
Personal name
Hidefumi Aoyama
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Southern TOHOKU Proton therapy center, University of Tsukuba Hospital, National Cancer Center Hospital East, Aizawa Hospital, Nagoya city university west medical center, Fukui prefectural hospital, Hyogo ion beam medical center, Medipolis Proton Therapy and Research Center, Tsuyama Chuo Hospital, Sapporo Teishinkai hospital, University hospital Kyoto prefectural university of medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2023 | Year | 10 | Month | 31 | 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
68
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The research has required more time than initially anticipated for presenting findings and publishing results, and an extension of the research period is planned.
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
| 2023 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A virtual X-ray treatment plans are created using images of patients that have undergone proton beam therapy in the past, and the normal tissue complication probability of each treatment will be calculated and compared.
Management information
Registered date
| 2023 | Year | 10 | Month | 31 | Day |
Last modified on
| 2024 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060097
