UMIN-CTR Clinical Trial

Basic information
Public title	Cyber knife as a treatment for malignant tumors: prospective observational study
Acronym	CK study
Scientific Title	Cyber knife as a treatment for malignant tumors: prospective observational study
Scientific Title:Acronym	CK study
Region	Japan

Condition
Condition	lung cancer, hepatoma, renal cancer, spinal cord tumor, and metastasis
Classification by specialty	Medicine in general Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the efficacy of cyber knife for malignant tumor.
Basic objectives2	Others
Basic objectives -Others	Local control rate.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Over all survival
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	5 fraction 35 to 45 Gy.
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	Diameter equal to 5 cm or less than 5cm, primary lung cancer, renal cancer or hepatoma, tumor numbers equal to 3 or less than 3 metastatic lung tumor or liver tumor. Local prostate cancer or pancreas cancer. Metastasis equal to 5 or less than 5. No organs failure. Informed consent.
Key exclusion criteria	Sever organs failure. Presence of dementia.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Takamasa Middle name Last name Ohki
Organization	Shioda Memorial Hospital
Division name	Cyber knife center
Zip code	297-0203
Address	kori 550-1 Nagaramachi Choseigun Chiba
TEL	0475-35-0099
Email	anb72547@nifty.com

Public contact
Name of contact person	1st name Takamasa Middle name Last name Ohki
Organization	Shioda Memorial Hospital
Division name	Cyber knife center
Zip code	297-0203
Address	kori 550-1 Nagaramachi Choseigun Chiba
TEL	0475-35-0099
Homepage URL
Email	anb72547@nifty.com

Sponsor
Institute	Shioda Memorial Hospital
Institute
Department

Funding Source
Organization	Shioda Memorial Hospital
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	Shioda Memorial Hospital
Address	kori 550-1 Nagaramachi Choseigun Chiba
Tel	0475-35-0099
Email	anb72547@nifty.com

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	2022 Year 05 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	Preinitiation
Date of protocol fixation	2022 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2022 Year 05 Month 01 Day
Last follow-up date	2032 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 04 Month 02 Day
Last modified on	2022 Year 04 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054025