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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019944
Receipt No. R000021489
Scientific Title Modified Simultaneous Integrated Boost Radiotherapy for Large tumor
Date of disclosure of the study information 2016/01/10
Last modified on 2017/08/09

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Basic information
Public title Modified Simultaneous Integrated Boost Radiotherapy for Large tumor
Acronym Modified Simultaneous Integrated Boost Radiotherapy for Large tumor
Scientific Title Modified Simultaneous Integrated Boost Radiotherapy for Large tumor
Scientific Title:Acronym Modified Simultaneous Integrated Boost Radiotherapy for Large tumor
Region
Japan

Condition
Condition More than 10 cm longest diameter or 5 cm shortest diameter clinically or pathologically visible malignant tumor
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the safety and effectiveness of modified SIB (Simultaneous Integrated Boost)radiotherapy for Locally advanced malignant tumor
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Initial tumor response
According to RECIST criteria (up to 6 months)
Key secondary outcomes 1) Toxicity
2) Local control
3) Cause specific survival rate
4) Overakk survival rate
5) QOL

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 Device,equipment
Interventions/Control_1 Radiotherapy
Up to tolerable dose to organ at risk
i.e., (2Gy/fr to intestine and 5Gy/fr to tumor central zone) Total 100Gy/20fr to tumor central zone and 40Gy/20fr to intestinal tract
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 and Female
Key inclusion criteria 1. Histologically or clinically diagnosed malignant tumor
2. Large measurable tumor more than 10 cm longest diameter or more than 5 cm shortest diameter
Key exclusion criteria 1. Unable to obtain wrriten infromed consent
2. Unsuitable for treat due to severe co-mobidity or mental dysorder
3 Unsuitable for treatby Physicians perspection
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yamazaki hideya
Organization Graduate School of Medical Science,
Kyoto Prefectural University of Medicine
Division name Department of Radiology
Zip code
Address 465 Kajiicho Kawaramachi Hirokoji Kamigyo-ku, Kyoto
TEL 075-251-5111
Email hideya10@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yamazaki Hideya
Organization Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name Department of Radiology
Zip code
Address 465 Kajiicho Kawaramachi Hirokoji Kamigyo-ku, Kyoto
TEL 075-251-5111
Homepage URL
Email hideya10@hotmail.com

Sponsor
Institute Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Dept. of Radiology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 10 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 Open public recruiting
Date of protocol fixation
2015 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 10 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
2015 Year 11 Month 26 Day
Last modified on
2017 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021489

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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