UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009615 |
|---|---|
| Receipt number | R000011280 |
| Scientific Title | Feasibility study of stereotactic body radiotherapy for prostate cancer |
| Date of disclosure of the study information | 2012/12/24 |
| Last modified on | 2016/12/26 14:15:53 |
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Basic information
Public title
Feasibility study of stereotactic body radiotherapy for prostate cancer
Acronym
Feasibility study of CyberKnife for prostate cancer
Scientific Title
Feasibility study of stereotactic body radiotherapy for prostate cancer
Scientific Title:Acronym
Feasibility study of CyberKnife for prostate cancer
Region
| Japan |
Condition
Condition
Early stage prostate cancer (T1-T2c and iPSA 10-20 ng/mL and GS=<6, T1-T2c and iPSA <10 ng/mL and GS=7)
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness and toxicity of Hypofractionated radiotherapy (35 Gy/5 fractions/ 10 days) using CyberKnife for early stage prostate cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Rate of acute adverse events
Key secondary outcomes
2-year PSA failure rate, 2-year clinical failure rate, recurrence pattern, late adverse events, rate of perprotocol, evaluation of dose distribution
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
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
| 50 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male
Key inclusion criteria
1) Adenocarcinoma
2) Low risk (T1-T2a and iPSA <10 ng/mL and GS=<6), or a partof Intermediate risk (T1-T2a and iPSA 10-20 ng/mL and GS=<6, or T1-T2a and iPSA <10 ng/mL and GS=7)
3) 50-84 years
4) No hormonral therapy or less than 8 months
5) PS 0-1
6) No privious radiotherapy histoly
7) Written informed consent
Key exclusion criteria
1) active double cancer(s)
2) Uncontrol DM
3) collagen disease, heart failure, sever respiratoy disease
4) Mental disease
5) Major operation of pelvic site
6) Surgery for prostate cancer
7) Chemotherapy for prostate cancer
8) Crohn's disease, Uncerlative colitis
9) Anti-coagulation agent
10) IPSS =<20
11) Artificial head
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoto Shikama |
Organization
Saitama Medical University, International Medical Center
Division name
Radiation Oncology
Zip code
Address
1397-1 Yamane, Hidaka-shi, 350-1298, Saitama Japan
TEL
042-984-4136
nshikama0525@gmailcom
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoto Shikama |
Organization
Saitama Medical University, International Medical Center
Division name
Radiation Oncology
Zip code
Address
1397-1 Yamane, Hidaka-shi, 350-1298, Saitama Japan
TEL
042-984-4136
Homepage URL
nshikama0525@gmail.com
Sponsor or person
Institute
Radiation Oncology, Saitama Medical University, International Medical Center
Institute
Department
Personal name
Funding Source
Organization
the Health and Labor Sciences Research Grant (H24-007)
Organization
Division
Category of Funding Organization
Other
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
埼玉医科大学国際医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 24 | Day |
Related information
URL releasing protocol
http://www.saitama-med.ac.jp/kokusai/
Publication of results
Published
Result
URL related to results and publications
https://doaj.org/toc/1920-454X?source=%7B%22query%22%3A%7B%22filtered%22%3A%7B%22filter%22%3A%7B%22b
Number of participants that the trial has enrolled
Results
The incidence of >grade 2 acute toxicity in all sites and that in the rectum after EHF-RT of 35 Gy in five fractions were 30% and 20%, respectively. High rectum-V28Gy was associated with grade 2 acute rectal toxicity after EHF-RT for early prostate cancer.
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
| 2012 | Year | 10 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 23 | Day |
Last modified on
| 2016 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011280
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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