UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase I/II clinical trial of Carbon-ion therapy in 12 fractions over 3 weeks for patients with carcinoma of kidney
Title of the study (Brief title)	A Phase I/II trial of Carbon-ion therapy for Renal Cancer
Region	Japan

Condition
Condition	Renal Cancer
Classification by specialty	Urology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to investigate safety and efficacy of the carbon ion therapy in 12 fractions for the renal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	Acute radiation toxicity of normal tissue
Key secondary outcomes	Late radiation toxicity of normal tissue Local control rate Survival rate

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	Radiotherapy (Carbon ion beam)
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)Pathologically confirmed renal cell carcinoma or renal tumor definitely diagnosed by the imaging as renal cell carcinoma. 2)Clear cell renal cell carcinoma, Chromophobe renal cell carcinoma, or Papillary renal cell carcinoma. 3)T1/T2N0M0 or T3 or more advanced tumor without tumor thrombus in the major vessels. 4)Performance status is 0 or 1
Key exclusion criteria	1)Past history of radiotherapy to the corresponding site. 2)Prior administration of the molecular targeting drugs. 3)Difficult to reduce the dose to the bowels to lower than 60% of the prescribed dose. 4)Tumor exceeding 15cm in maximum diameter. 5)Atypical renal cancer such as Bellini duct carcinoma 6)Carcinome developed in dialyzed kidney 7)Active other malignancy
Target sample size	10

Research contact person
Name of lead principal investigator	Tsuji Hiroshi
Organization	National Institute of Radiological Sciences
Division name	Research Center for Charged particle therapy
Address	4-9-1, Anagawa, Inage-ku Chiba
TEL	043-206-3360
Email	h_tsuji@nirs.go.jp

Public contact
Name of contact person	Tsuji Hiroshi
Organization	National Institute of Radiological Sciences
Division name	Research Center for Charged particle therapy
Address	4-9-1, Anagawa, Inage-ku Chiba
TEL	043-206-3360
Homepage URL
Email	h_tsuji@nirs.go.jp

Sponsor
Institute	National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization	National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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	2012 Year 09 Month 01 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2012 Year 06 Month 07 Day
Anticipated trial start date	2012 Year 09 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 08 Month 27 Day
Last modified on	2016 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010316