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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013428
Receipt No. R000015572
Scientific Title Feasibility study of stereotactic body radiotherapy for metastatic vertebral body tumor
Date of disclosure of the study information 2014/03/14
Last modified on 2014/03/14

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Basic information
Public title Feasibility study of stereotactic body radiotherapy for metastatic vertebral body tumor
Acronym Feasibility study of SBRT for metastatic vertebral body tumor
Scientific Title Feasibility study of stereotactic body radiotherapy for metastatic vertebral body tumor
Scientific Title:Acronym Feasibility study of SBRT for metastatic vertebral body tumor
Region
Japan

Condition
Condition metastatic vertebral body tumor
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the feasibility of stereotactic body radiotherapy for metastatic vertebral body tumor in Japan.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Rate of Grade 3 or worse adverse effects after 6 months from treatment.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 stereotactic body radiotherapy (24 Gy/2 fractions or 24 Gy/3 fractions) for metastatic vertebral body tumor
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) ECOG PS; 0-1.
2) RPA score Group 1 or Group 2.
3) A solitary spine metastasis or two contiguous spine levels involved.
4) No previous radiation to target.
5) Lesion which is made diagnoses with MRI within 12 weeks.
6) Pathologically-confirmed cancer.
7) Patient who can keep position while treatment.
8) Patient who can understand and write informed consent in Japanese.
9) Lesion whisc is stable in SINS score.
Key exclusion criteria 1) Patient who cannot get MRI
2) Patient who has uncontrolled collagen disease, cardiac disease, respiratory disease or liver disorders.
3) Patient who has progressive neural symptom
4) Lesion which has cord compression grade 2 or 3.
5) Lesion which has vertebral compression fracture.
6) Patient who had chemotherapy with in 1 week before SBRT.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuyuki Karasawa
Organization Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name Division of Radiation Oncology
Zip code
Address 18-22,Honkomagome 3chome,Bunkyo-ku,Tokyo
TEL 03-3823-2101
Email karasawa@cick.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Tanaka
Organization Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name Division of Radiation Oncology
Zip code
Address 18-22,Honkomagome 3chome,Bunkyo-ku,Tokyo
TEL 03-3823-2101
Homepage URL
Email hirostan@cick.jp

Sponsor
Institute Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Institute
Department

Funding Source
Organization Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization Local Government
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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions がん・感染症センター都立駒込病院(東京都)、埼玉医科大学国際医療センター(埼玉県)、神戸低侵襲がん医療センター(兵庫県)

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 14 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 Open public recruiting
Date of protocol fixation
2014 Year 03 Month 05 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 03 Month 14 Day
Last modified on
2014 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015572

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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