UMIN-CTR Clinical Trial

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 Takahiro Middle name Last name Hodumi
Organization	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name	Orthopedic surgery
Zip code	1138677
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 Kei Middle name Last name Ito
Organization	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name	Division of Radiation Oncology, Department of Radiology
Zip code	1138677
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	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Address	Hon-komagome 3-18-22, Bunkyo-ku
Tel	03-3823-2101
Email	rinri@cick.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	2017 Year 06 Month 15 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	20
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	Main results already published
Date of protocol fixation	2017 Year 06 Month 15 Day
Date of IRB	2017 Year 06 Month 15 Day
Anticipated trial start date	2017 Year 06 Month 15 Day
Last follow-up date	2020 Year 08 Month 01 Day
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	2021 Year 02 Month 13 Day

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