UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042430 |
|---|---|
| Receipt number | R000048439 |
| Scientific Title | Survey of tomotherapy for methotelioma in Japan: patterns of practice and clinical outcomes. |
| Date of disclosure of the study information | 2020/11/13 |
| Last modified on | 2022/05/15 16:03:17 |
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Basic information
Public title
Survey of tomotherapy for methotelioma in Japan: patterns of practice and clinical outcomes.
Acronym
Survey of tomotherapy for methotelioma in Japan: patterns of practice and clinical outcomes.
Scientific Title
Survey of tomotherapy for methotelioma in Japan: patterns of practice and clinical outcomes.
Scientific Title:Acronym
Survey of tomotherapy for methotelioma in Japan: patterns of practice and clinical outcomes.
Region
| Japan |
Condition
Condition
Malignant pleural mesothelioma
Classification by specialty
| Chest surgery | Radiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
There are few reports of malignant pleural mesothelioma due to its frequency in Japan. In addition, the radiation treatment plan is considered to be heterogeneous in individual cases at the tumor site and at-risk organs. The purpose of this study is to analyze the current status of curative radiation therapy for malignant pleural mesothelioma by tomotherapy and to evaluate the current treatment results in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Underwent radicak radiation therapy using Tomotherapy (Including combined use of Tomotherapy and Linic).
2. Prescription dose is more tan 45Gy (Including cases did not reach the priscriotion dose).
3. Whether or not the tumor remains after surgery.
4. Whether or not chemotherapy is used in combination.
5. With or without surgical surgery (including preoperative irradiation and no surgery).
6. Stage III or less in TMN stage classification.
Key exclusion criteria
1. Under 20 years of age during radiation therapy.
2. Cases had underwent radiation therapy to the chest
3. Histopathologically undetermined or unconscionable diagnosis
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Murai |
Organization
Nagoya City University
Division name
Department of Radiology
Zip code
4678601
Address
1 Kawasumi, Mizuho-cho, Mizuoho-ku,Nagoya-shi,Aichi
TEL
0528538276
taro8864@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mikiko |
| Middle name | |
| Last name | Imai |
Organization
Nagoya City University
Division name
Department of Radiology
Zip code
4678601
Address
1 Kawasumi, Mizuho-cho, Mizuoho-ku,Nagoya-shi,Aichi
TEL
0528538276
Homepage URL
nakanishi.ncu@gmail.com
Sponsor or person
Institute
Nagoya City University
Department of Radiology
Institute
Department
Personal name
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
Nagoya City University Hospital
Address
1 Kawasumi, Mizuho-cho, Mizuoho-ku,Nagoya-shi,Aichi
Tel
0528515511
nakanishi.ncu@gmail.com
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
| 2020 | Year | 11 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35138408/
Number of participants that the trial has enrolled
31
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
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2020 | Year | 11 | Month | 12 | Day |
Last modified on
| 2022 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048439
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
