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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042430
Receipt No. 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 2020/11/12

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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
Email 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
Email nakanishi.ncu@gmail.com

Sponsor
Institute Nagoya City University
Department of Radiology
Institute
Department

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
Email 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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 32
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
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
2020 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048439

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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