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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010517
Receipt No. R000012276
Scientific Title Interfractional displacement and variation of prostate during multifractionated high-dose-rate interstitial brachytherapy
Date of disclosure of the study information 2013/04/19
Last modified on 2018/05/05

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Basic information
Public title Interfractional displacement and variation of prostate during multifractionated high-dose-rate interstitial brachytherapy
Acronym Interfractional displacement and variation of prostate during multifractionated high-dose-rate interstitial brachytherapy
Scientific Title Interfractional displacement and variation of prostate during multifractionated high-dose-rate interstitial brachytherapy
Scientific Title:Acronym Interfractional displacement and variation of prostate during multifractionated high-dose-rate interstitial brachytherapy
Region
Japan

Condition
Condition prostate cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to measure prostate displacement and valiation during the treatment of high dose rate interstitial brachytherapy by CT, and to establish the best optimization protocol.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The displacement measurement of the applicator for the marker in the prostate during the prostatic monotherapy period.
Key secondary outcomes Evaluation of the change of DVH of OAR and CTV with the displacement.

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
Medicine
Interventions/Control_1 Measure the displacement of needle applicator according to the gold marker inserted in prostate by CT during high dose rate interstitial monothreapy treatment period
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
80 years-old >=
Gender Male
Key inclusion criteria *Histologically proven prostate cancer
*Any Gleason Score
*Any pretreatment PSA
*Any T stage
*Clinicaly diagnosed as N0M0 with MRI, bone scan, CT and so on.
*Use UICC TNM2009 for staging.
*ECOG performance status 0 or 1.
*Blood test results are compatible with criterias as below.
WBC>=3000/ul, Hb>=10.0g/dl, Plt>=100000/ul, Cre>=2.0 mg/dl, GOT>=100U/L, GPT<=100U/L
*Without any history of local therapy such as operation, trans-urethral procedure, hyperthermia. Hormonal therapy is permitted.
*Informed concented cases.
Key exclusion criteria *Case having an active synchronous double cancer.
*Case having an uncontrollable diabetes .
*Case having a complication that doesn't quit internal use of anticoagulant.
*Case having a serious cranial nerve disease
*Case having collagenosis
*The case that the examination medical attendant judged to be inappropriate
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Yoshioka
Organization Osaka University Graduate School of Medicine
Division name Radiation Oncology
Zip code
Address 2-2 D10, Yamadaoka, Suita
TEL 06-6879-3482
Email yoshioka@radonc.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Osamu Suzuki
Organization Osaka University Graduate School of Medicine
Division name Radiation Oncology
Zip code
Address 2-2 D10, Yamadaoka, Suita
TEL 06-6879-3482
Homepage URL
Email osamu-s@umin.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine, Dept of Radiation Oncology
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization none

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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 大阪大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 19 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 Enrolling by invitation
Date of protocol fixation
2013 Year 04 Month 11 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 22 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2015 Year 01 Month 31 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 04 Month 17 Day
Last modified on
2018 Year 05 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012276

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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