UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042491
Receipt number R000048504
Scientific Title Multiinsitutional prospective observational study of Radiotherapy for metastatis bone tumor
Date of disclosure of the study information 2020/12/01
Last modified on 2021/05/20 11:32:53

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Basic information

Public title

Multiinsitutional prospective observational study of Radiotherapy for metastatis bone tumor

Acronym

Multiinsitutional prospective observational study of Radiotherapy for metastatis bone tumor

Scientific Title

Multiinsitutional prospective observational study of Radiotherapy for metastatis bone tumor

Scientific Title:Acronym

Multiinsitutional prospective observational study of Radiotherapy for metastatis bone tumor

Region

Japan


Condition

Condition

Metastatic bone tumor

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the actual patients characteristics and therapeutic effect of radiation therapy for bone metastasis in clinical practice in Japan

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1)type of cancer, treatment policy, irradiation method

Key secondary outcomes

2)pain response, skeletal related event
3)Toxicity
4)Quality of life,employment status


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Radiotherapy for bone metastasis is planned
Written informed consent

Key exclusion criteria

Inappropriate for study participation by the treating physician

Target sample size

280


Research contact person

Name of lead principal investigator

1st name Hideyuki
Middle name
Last name Harada

Organization

Shizuoka Cancer Center

Division name

Radiation and Proton Therapy Center

Zip code

4118777

Address

1007 shimonagakubo, Nagaizumi, Shizuoka

TEL

0559895222

Email

h.harada@scchr.jp


Public contact

Name of contact person

1st name Hideyuki
Middle name
Last name Harada

Organization

Shizuoka Cancer Center

Division name

Radiation and Proton Therapy Center

Zip code

4118777

Address

1007 shimonagakubo, Nagaizumi, Shizuoka

TEL

0559895222

Homepage URL


Email

h.harada@scchr.jp


Sponsor or person

Institute

Shizuoka Cancer Center

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labor and Welfare

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

Shizuoka Cancer Center IRB

Address

1007 shimonagakubo, Nagaizumi, Shizuoka

Tel

0559895222

Email

tansaku_office@scchr.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

2020 Year 12 Month 01 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

No longer recruiting

Date of protocol fixation

2020 Year 10 Month 09 Day

Date of IRB

2020 Year 10 Month 09 Day

Anticipated trial start date

2020 Year 12 Month 01 Day

Last follow-up date

2021 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Target number of registrations: Maximum 270 cases (upper limit per facility is 10 cases)
Registration; Dec 2020 to Mar 2021
Follow up; Until Sep 2021


Management information

Registered date

2020 Year 11 Month 18 Day

Last modified on

2021 Year 05 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048504


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name