UMIN-CTR Clinical Trial

Basic information
Public title	Phase II trial of second course of spine stereotactic body radiotherapy
Acronym	Phase II trial of second course of spine stereotactic body radiotherapy
Scientific Title	Phase II trial of second course of spine stereotactic body radiotherapy
Scientific Title:Acronym	Phase II trial of second course of spine stereotactic body radiotherapy
Region	Japan

Condition
Condition	spinal metastases
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of second stereotactic body radiotherapy for spinal metastases
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Occurance rate of dose limiting toxicities within 1 year after second SBRT
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	Device,equipment
Interventions/Control_1	SBRT of 30 Gy in 5 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 2. the target spine or ajdcent spine with history of SBRT 3. recurence of spine metastases confirmed by MRI 4. not radiosensitive histology 5. interval from the last SBRT more than 6 months 6. be able to keep supine position for 1 hour 7. prognosis is expected more than 6 months 8. Written informed consent
Key exclusion criteria	with severe comobidities
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Katsuyuki Middle name Last name Karasawa
Organization	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name	Division of Radiation Oncology, Department of Radiology
Zip code	1138677
Address	Hon-komagome 3-18-22, Bunkyo-ku
TEL	03-3823-2101
Email	karasawa@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	Hon-komagome 3-18-22, Bunkyo-ku
TEL	03-3823-2101
Homepage URL
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	0338232101
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	2021 Year 04 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	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	No longer recruiting
Date of protocol fixation	2021 Year 01 Month 25 Day
Date of IRB	2021 Year 06 Month 21 Day
Anticipated trial start date	2021 Year 04 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 02 Month 13 Day
Last modified on	2022 Year 08 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049455