UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030964
Receipt No. R000035318
Scientific Title Carbon-ion radiotherapy for patients with renal cell carcinoma
Date of disclosure of the study information 2018/01/25
Last modified on 2019/07/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Carbon-ion radiotherapy for patients with renal cell carcinoma
Acronym Carbon-ion radiotherapy for patients with renal cell carcinoma
Scientific Title Carbon-ion radiotherapy for patients with renal cell carcinoma
Scientific Title:Acronym Carbon-ion radiotherapy for patients with renal cell carcinoma
Region
Japan

Condition
Condition Renal cell carcinoma
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of carbon-ion radiotherapy for renal cell carcinoma.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes safety
Key secondary outcomes efficacy

Base
Study type Interventional

Study design
Basic design expanded access
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 16 or 12 fractionated carbon ion 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with renal cell carcinoma
refusal of surgery or inoperable cases
Key exclusion criteria Patients treated with carbon ion radiotherapy
Target sample size 27

Research contact person
Name of lead principal investigator
1st name goro
Middle name
Last name kasuya
Organization Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology
Division name Hospital
Zip code 263-8555
Address 4-9-1 Anagawa, Inage Ward, Chiba-City, 263-8555 Japan.
TEL 043-206-3306
Email kasuya.goro@qst.go.jp

Public contact
Name of contact person
1st name goro
Middle name
Last name kasuya
Organization Hospital of the National Institute of Radiological Sciences
Division name Hospital
Zip code 2638555
Address 4-9-1 Anagawa, Inage Ward, Chiba-City, 263-8555 Japan.
TEL 043-206-3306
Homepage URL
Email kasuya.goro@qst.go.jp

Sponsor
Institute Hospital of the National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Reliability Assurance / Audit Office
Address 4-9-1 Anagawa, Inage Ward, Chiba-City, 263-8555 Japan.
Tel 043-206-4706
Email helsinki@qst.go.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
2018 Year 01 Month 25 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 27
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
2018 Year 01 Month 10 Day
Date of IRB
2018 Year 01 Month 10 Day
Anticipated trial start date
2018 Year 01 Month 25 Day
Last follow-up date
2019 Year 01 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 24 Day
Last modified on
2019 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035318

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.