UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029469 |
|---|---|
| Receipt number | R000033670 |
| Scientific Title | A Phase I/II clinical trial of Carbon-ion radiotherapy in 4 fractions over 1 week for patients with renal cell carcinoma |
| Date of disclosure of the study information | 2017/10/10 |
| Last modified on | 2024/03/05 14:12:05 |
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Basic information
Public title
A Phase I/II clinical trial of Carbon-ion radiotherapy in 4 fractions over 1 week for patients with renal cell carcinoma
Acronym
Carbon-ion radiotherapy in 4 fractions for patients with renal cell carcinoma
Scientific Title
A Phase I/II clinical trial of Carbon-ion radiotherapy in 4 fractions over 1 week for patients with renal cell carcinoma
Scientific Title:Acronym
Carbon-ion radiotherapy in 4 fractions for patients with renal cell carcinoma
Region
| Japan |
Condition
Condition
Renal cell carcinoma
Classification by specialty
| Nephrology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of carbon-ion radiotherapy in 4 fractionsfor patients with renal cell carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Acute adverse effect (within 90 days)
Key secondary outcomes
late adverse effect, local control, cancer specific survival, overall survival, QOL
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
Carbon-ion radiotherapy 55.2 Gy (RBE) in 4 fractions within 1 week, increased to 60.0Gy(RBE)from 6th case.
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) biopsy-proven, or imaging diagnosed renal cell carcinoma
2) historogy: clear cell carcinoma, chromophobe cell carcinoma, or papillary renal cell carcinoma
3) untreated T1/T2, or T3/T4 without tumor emboli. In addition, N1M1 case with long term prognosis (according to TNM classification 2016).
4) an age >= 20
5) Performance Status (ECOG): 0-1
6)documented informed consent
Key exclusion criteria
1)target area that had been treated by other radiation therapy
2) After the start of molecular targetting therapy
3) irradiated dose to gastrointestinal tract is more than 60% of prescribed dose
4) maximum tumor diameter > 15cm
5) dialyzed RCC
6) presence of active double cancers other than RCC
7) serious medical or psychological condition precluding the safe administration of the treatment
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Ishikawa |
Organization
National Institutes for Quantum Science and Technology
Division name
QST hospital
Zip code
263-8555
Address
4-9-1 Anagawa, Inage Ward, Chiba-City, Japan
TEL
09097858517
gokasuya@gmail.com
Public contact
Name of contact person
| 1st name | Goro |
| Middle name | |
| Last name | Kasuya |
Organization
National Institutes for Quantum Science and Technology
Division name
QST hospital
Zip code
263-8555
Address
4-9-1 Anagawa, Inage Ward, Chiba-City, Japan
TEL
043-206-3360
Homepage URL
kasuya.goro@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes for Quantum Science and Technology Certified Review Board
Address
4-9-1 Anag awa, Inage-ku, Chiba-shi, Chiba
Tel
0 4 3 -2 0 6 -4 7 0 6
helsinki@ q s t.g o .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 | 10 | Month | 10 | 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
10
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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 17 | 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 | 10 | Month | 08 | Day |
Last modified on
| 2024 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033670
| Research Plan | |
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| Registered date | File name |
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