UMIN-CTR Clinical Trial

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	2022 Year 02 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035318