UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011631 |
|---|---|
| Receipt number | R000013603 |
| Scientific Title | A phase II clinical trial of carbon-ion radiotherapy using 12 fractions for prostate cancer |
| Date of disclosure of the study information | 2013/09/03 |
| Last modified on | 2014/09/02 11:02:17 |
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Basic information
Public title
A phase II clinical trial of carbon-ion radiotherapy using 12 fractions for prostate cancer
Acronym
A phase II clinical trial of carbon-ion radiotherapy using 12 fractions for prostate cancer
Scientific Title
A phase II clinical trial of carbon-ion radiotherapy using 12 fractions for prostate cancer
Scientific Title:Acronym
A phase II clinical trial of carbon-ion radiotherapy using 12 fractions for prostate cancer
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of carbon-ion radiotherapy using 12 fractions for prostate cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
(biochemically or clinically) relapse free survival rate
Key secondary outcomes
overall survival rate, cause-specific survival rate, normal tissue reaction, quality of life
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
| Maneuver |
Interventions/Control_1
Carbon-ion beam
total dose 51.6 GyE
12 fractions
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
Key inclusion criteria
1) Patients of prostate cancer with pathollogical diagnosis
2) Patients with T1c-3N0M0 tumour accrdiong to UICC(International Union Against Cancer) TMN classification of Malignant tumours 7th edition.
3) Perfomance status of the patient is from zero to two.
4) Life expectancy of the patients is longer than one year.
5) Regarding risk group and hormonal therapy, patients are matched following (a) or (b); (a) low risk patients have never received hormonal therapy, (b) intermediate patients and high risk patients received hormonal therapy longer than four months and shorter than eight months at the first day of the carbon-ion radiotherapy.
Key exclusion criteria
1) Patients have received radiotherapy at the same position where carbon-ion radiotherapy is palanned.
2) Patients have received any kinds of therapies except hormonal therapy.
3) Patients have any other active malignancies.
4) Patients with active and intractable infection at the same position where carbon-ion radiotherapy is palanned.
5) Patients with evidence of elevation of PSA after starting of hormonal therapy and before starting of carbon-ion radiotherapy.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Shioyama |
Organization
SAGA HIMAT foundation
Division name
Ion Beam Therapy Center
Zip code
Address
415 Harakoga-machi, Tosu, Saga 841-0071 Japan
TEL
0942-81-1897
shioyama-yoshiyuki@saga-himat.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Toyama |
Organization
SAGA HIMAT foundation
Division name
Ion Beam Therapy Center
Zip code
Address
415 Harakoga-machi, Tosu, Saga 841-0071 Japan
TEL
0942-81-1897
Homepage URL
toyama-shingo@saga-himat.jp
Sponsor or person
Institute
SAGA HIMAT foundation
Institute
Department
Personal name
Funding Source
Organization
SAGA HIMAT foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
九州国際重粒子線がん治療センター（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 03 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 08 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 02 | Day |
Last modified on
| 2014 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013603
