UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047367 |
|---|---|
| Receipt number | R000054025 |
| Scientific Title | Cyber knife as a treatment for malignant tumors: prospective observational study |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2022/04/02 10:00:59 |
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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
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
anb72547@nifty.com
Sponsor or person
Institute
Shioda Memorial Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054025
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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