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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026247
Receipt No. R000030147
Scientific Title Pain relief period by external irradiation for bone metastasis
Date of disclosure of the study information 2017/02/22
Last modified on 2017/02/21

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Basic information
Public title Pain relief period by external irradiation for bone metastasis
Acronym Pain relief period of bone metastasis
Scientific Title Pain relief period by external irradiation for bone metastasis
Scientific Title:Acronym Pain relief period of bone metastasis
Region
Japan

Condition
Condition Bone metastasis
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In this study, as fundamental information for studying new pain relief treatment for bone metastasis, we will grasp the pain relief period in external radiation therapy currently being done as a standard treatment of bone metastasis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain relief period
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. Diagnosis of cancer is attached by histological examination from the primary site or metastasis site.
2. The cause of pain can be specified on the image.
3. There is no history of radiotherapy for the pain site.
4. The patient is informed about the disease, and the patient consent has been obtained
Key exclusion criteria 1. No fractures or no spinal cord compression symptoms.
2. The doctor judges that the patient is inappropriate.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Anneyuko Saito
Organization Juntendo University Urayasu Hospital
Division name Department of Radiology
Zip code
Address 2-1-1, Tomioka, Urayasu, Chiba, Japan
TEL 047-353-3111
Email nyusaike@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryoichi Yoshimura
Organization Tokyo Medical and Dental University
Division name Radiation Therapeutics and Oncology
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5311
Homepage URL
Email ysmrmrad@tmd.ac.jp

Sponsor
Institute Juntendo University Urayasu Hospital,
Tokyo Medical and Dental University,
and Showa University
Institute
Department

Funding Source
Organization Ministry of education, culture, sports, science, and technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 M2000-2142
Org. issuing International ID_1 Tokyo Medical and Dental University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 順天堂大学医学部附属浦安病院(千葉県)、東京医科歯科大学医学部附属病院(東京都)、昭和大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 22 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
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
2012 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patient registration was done at three university hospitals, and cases were accumulated, so registration finished now and analysis started.

Management information
Registered date
2017 Year 02 Month 21 Day
Last modified on
2017 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030147

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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