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Recruitment status
Unique ID issued by UMIN UMIN000008777
Receipt No. R000010316
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
Date of disclosure of the study information 2012/09/01
Last modified on 2016/11/01

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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
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

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
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