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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009615
Receipt No. 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

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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
Email 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
Email nshikama0525@gmail.com

Sponsor
Institute Radiation Oncology, Saitama Medical University, International Medical Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011280

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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