UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective study of focal radiotherapy for pleural dissemination of thymic tumors
Acronym	Focal radiotherapy for pleural dissemination of thymic tumors
Scientific Title	Retrospective study of focal radiotherapy for pleural dissemination of thymic tumors
Scientific Title:Acronym	Focal radiotherapy for pleural dissemination of thymic tumors
Region	Japan

Condition
Condition	Thymic tumors
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study aims to investigate the usefulness of radiotherapy in patients who had local pleural dissemination of thymoma
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival after radiation therapy
Key secondary outcomes	local control rate, progression-free survival rate

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	The patients who had been clinically or histologically diagnosed with recurrent pleural dissemination of thymoma and received radiation therapy in our institution between January 2004 and June 2019.
Key exclusion criteria	1)Having a history of chemotherapy or radiation therapy in the past with different carcinomas 2)Having serious complications 3)Having active double cancer 4)Pregnant or possibly pregnant 5)Under 20-year-old 6)Palliative care
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Dai Middle name Last name Okazaki
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Radiology
Zip code	467-8601
Address	1 Kawasumi, Mizuho-cho, Mizuoho-ku, Nagoya-shi,Aichi, Japan
TEL	052-853-8276
Email	g-u1016@hotmail.co.jp

Public contact
Name of contact person	1st name Dai Middle name Last name Okazaki
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Radiology
Zip code	467-8601
Address	1 Kawasumi, Mizuho-cho, Mizuoho-ku, Nagoya-shi,Aichi, Japan
TEL	052-853-8276
Homepage URL
Email	g-u1016@hotmail.co.jp

Sponsor
Institute	Department of Radiology, Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical Research Management Center, Nagoya City University Hospital
Address	1 Kawasumi, Mizuho-cho, Mizuoho-ku, Nagoya-shi,Aichi, Japan
Tel	052-858-7215
Email	clinical_research@med.nagoya-cu.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	2019 Year 09 Month 05 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	20
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 04 Day
Date of IRB	2019 Year 10 Month 03 Day
Anticipated trial start date	2019 Year 09 Month 04 Day
Last follow-up date	2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observative analysis of Radiation Therapy

Management information
Registered date	2019 Year 09 Month 04 Day
Last modified on	2021 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043220