UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045721 |
|---|---|
| Receipt number | R000052194 |
| Scientific Title | Phase II study of stereotactic radiotherapy for kidney cancer using an MR-Linac system |
| Date of disclosure of the study information | 2021/10/29 |
| Last modified on | 2025/04/14 10:19:47 |
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Basic information
Public title
Phase II study of stereotactic radiotherapy for kidney cancer using an MR-Linac system
Acronym
MR-Linac based stereotactic radiotherapy for kidney cancer
Scientific Title
Phase II study of stereotactic radiotherapy for kidney cancer using an MR-Linac system
Scientific Title:Acronym
MR-Linac based stereotactic radiotherapy for kidney cancer
Region
| Japan |
Condition
Condition
Kidney cancer(primary kidney cancer)
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of MR-Linac based stereotactic radiotherapy for primary kidney cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
One-year local control and the rate of occurrence of serious adverse event.
Key secondary outcomes
One-year overall survival and 1-year progression free survival
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
MR-Linac based stereotactic radiotherapy
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)Primary kidney cancer which has pathological diagnosis or clinical diagnosis
(2)T1N0M0, or T1NanyMany and all lymph nodes and distant metastases have been controlled
(3)Performance status is from 0 to 2
(4)Twenty or more years old
(5)Urologists and radiologists agree to perform stereotactic radiotherapy instead of surgery or cryotherapy, or patient refused surgery and cryotherapy.
(6)Written informed consent
Key exclusion criteria
(1)Radiation oncologists judge not to have a tolerance or not to be suitable for stereotacitc radiotherapy because of coexisting illness
(2)Double cancer or past history of double cancer within 3 years.
(3)Implanted metal in the body
(4)Mental disorder, especially claustrophobiady
(5)Infection
(6)Pregnant or lactating woman, likelihood of pregnancy
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Takaya |
| Middle name | |
| Last name | Yamamoto |
Organization
Tohoku University Hospital
Division name
Department of Radiation Oncology
Zip code
9808575
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
+81-22-717-7312
takaya.yamamoto.c3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Noriyoshi |
| Middle name | |
| Last name | Takahashi |
Organization
Tohoku University Hospital
Division name
Department of Radiation Oncology
Zip code
9808575
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
+81-22-717-7312
Homepage URL
noriyoshi.08.25@gmail.com
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Tohoku Certified Review Board of Tohoku University
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
Tel
022-728-4105
rinri-2@proj.med.tohoku.ac.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 | 10 | Month | 29 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2021 | Year | 10 | Month | 11 | Day |
Last modified on
| 2025 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052194
