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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029469
Receipt No. 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 2019/10/10

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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
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 Goro
Middle name
Last name Kasuya
Organization QST hospital
Division name hospital
Zip code 263-8555
Address 4-9-1 Anagawa, Inage Ward, Chiba-City, Japan
TEL 09097858517
Email gokasuya@gmail.com

Public contact
Name of contact person
1st name Goro
Middle name
Last name Kasuya
Organization the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sc
Division name hospital
Zip code 263-8555
Address 4-9-1 Anagawa, Inage Ward, Chiba-City, Japan
TEL 043-206-3360
Homepage URL
Email kasuya.goro@qst.go.jp

Sponsor
Institute the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology
Institute
Department

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 and Radiolog ical Science a 7 nd Technolog y 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
Email 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
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 Open public recruiting
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 09 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
2017 Year 10 Month 08 Day
Last modified on
2019 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033670

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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