UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019944 |
|---|---|
| Receipt number | R000021489 |
| Scientific Title | Modified Simultaneous Integrated Boost Radiotherapy for Large tumor |
| Date of disclosure of the study information | 2016/01/10 |
| Last modified on | 2023/06/02 11:59:20 |
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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 | hideya |
| Middle name | |
| Last name | Yamazaki |
Organization
Graduate School of Medical Science,
Kyoto Prefectural University of Medicine
Division name
Department of Radiology
Zip code
602-0841
Address
465 Kajiicho Kawaramachi Hirokoji Kamigyo-ku, Kyoto
TEL
075-251-5111
hideya10@hotmail.com
Public contact
Name of contact person
| 1st name | Hideya |
| Middle name | |
| Last name | Yamazaki |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Radiology
Zip code
602-0841
Address
465 Kajiicho Kawaramachi Hirokoji Kamigyo-ku, Kyoto
TEL
075-251-5111
Homepage URL
hideya10@hotmail.com
Sponsor or person
Institute
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
Kyoto Prefectural University of Medicine
Address
Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajiicho Kawaramachi Hirokoji, Kamigyo-ku, Kyoto 602-8566
Tel
075-251-5111
hideya10@hotmail.com
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
| 2015 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
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
| 2023 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021489
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
