UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness and adverse effects of radical radiotherapy on patients aged 90 or above
Title of the study (Brief title)	Radiotherapy for aged 90 or above
Region	Japan

Condition
Condition	all malignancy
Classification by specialty	Hematology and clinical oncology Radiology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study is to evaluate for radical radiotherapy for aged 90 or above.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	local control and overall survival
Key secondary outcomes	change of QOL

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	90 years-old <=
Age-upper limit	110 years-old >=
Gender	Male and Female
Key inclusion criteria	aged 90 or above determination by theiselves
Key exclusion criteria	patients with misunderstanding this study
Target sample size	20

Research contact person
Name of lead principal investigator	Osamu Tanaka
Organization	Gifu Municipal Hospital
Division name	Department of Radiation Oncology
Address	7-1Kashima-cho GIfu Gifu
TEL	058-251-1101
Email	c.bluered@gmail.com

Public contact
Name of contact person	Osamu Tanaka
Organization	Gifu Municipal Hospital
Division name	Department of Radiation Oncology
Address	7-1 Kashima-cho Gifu Gifu
TEL	+81582511101
Homepage URL
Email	c.bluered@gmail.com

Sponsor
Institute	Gifu Municipal Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2016 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 01 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We retrospectively analyse the outcome of radiotherapy for aged 90 or above

Management information
Registered date	2016 Year 12 Month 01 Day
Last modified on	2017 Year 06 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028861