UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008777 |
|---|---|
| Receipt number | R000010316 |
| Scientific Title | 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 14:10:04 |
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Basic information
Public title
A phase I/II clinical trial of Carbon-ion therapy in 12 fractions over 3 weeks for patients with carcinoma of kidney
Acronym
A Phase I/II trial of Carbon-ion therapy for Renal Cancer
Scientific Title
A phase I/II clinical trial of Carbon-ion therapy in 12 fractions over 3 weeks for patients with carcinoma of kidney
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tsuji Hiroshi |
Organization
National Institute of Radiological Sciences
Division name
Research Center for Charged particle therapy
Zip code
Address
4-9-1, Anagawa, Inage-ku Chiba
TEL
043-206-3360
h_tsuji@nirs.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuji Hiroshi |
Organization
National Institute of Radiological Sciences
Division name
Research Center for Charged particle therapy
Zip code
Address
4-9-1, Anagawa, Inage-ku Chiba
TEL
043-206-3360
Homepage URL
h_tsuji@nirs.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Date of protocol fixation
| 2012 | Year | 06 | Month | 07 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010316
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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