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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027519
Receipt No. R000031543
Scientific Title A Prospective trial of Decompression Surgery and Intraoperative Radiotherapy for Metastatic Epidural Spinal Cord Compression
Date of disclosure of the study information 2017/06/15
Last modified on 2017/11/27

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Basic information
Public title A Prospective trial of Decompression Surgery and Intraoperative Radiotherapy for Metastatic Epidural Spinal Cord Compression
Acronym Intraoperative Radiotherapy for Metastatic Epidural Spinal Cord Compression
Scientific Title A Prospective trial of Decompression Surgery and Intraoperative Radiotherapy for Metastatic Epidural Spinal Cord Compression
Scientific Title:Acronym Intraoperative Radiotherapy for Metastatic Epidural Spinal Cord Compression
Region
Japan

Condition
Condition Metastatic Epidural Spinal Cord Compression
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and toxicity of decompression surgery and intra-operative radiotherapy for metastatic epidural spinal cord compression.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Ambulatory function, local control at 1 year
Key secondary outcomes local control at 3 years, OS, local progression free survival, pattern of failure, pain response, Adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Surgical decompression and Intra-operative radiotherapy of 20 Gy.
Adjuvant external body radiotherapy of 30 Gy in 10 fractions
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. pathological or clinical diagnosis of primary cancer (including sarcoma)
2. spine metastases confirmed by images
3. Symptoms by the tumor
4. Bilsky grade is more than Ib or SINS is potentially unstable/unstable
5. Age; 20-
6. prognosis is expected more than 6 months
7. Written informed consent
Key exclusion criteria 1. Radiosensitive histology
2. untlerable to surgery
3. complete paralysis more than 48 hours
4. impossible to conduct decompression surgery
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Hodumi
Organization Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name Orthopedic surgery
Zip code
Address 3-18-22 Honkomagome, Bunkyo-ku,Tokyo
TEL 03-3823-2101
Email t.hoz@cick.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kei Ito
Organization Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name Division of Radiation Oncology, Department of Radiology
Zip code
Address 3-18-22 Honkomagome, Bunkyo-ku,Tokyo
TEL 03-3823-2101
Homepage URL http://www.cick.jp/houshasenchiryou/housha_shiken/
Email keiito@cick.jp

Sponsor
Institute Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome 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)

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

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 15 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
2017 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 15 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
2017 Year 05 Month 28 Day
Last modified on
2017 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031543

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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