UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017227 |
|---|---|
| Receipt number | R000019976 |
| Scientific Title | Prospective Phase II Study of Image-guided Local Boost Using a Real-time Tumor-tracking Radiotherapy (RTRT) System for Locally Advanced Bladder Cancer |
| Date of disclosure of the study information | 2015/04/21 |
| Last modified on | 2015/04/21 22:54:15 |
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Basic information
Public title
Prospective Phase II Study of Image-guided Local Boost Using a Real-time Tumor-tracking Radiotherapy (RTRT) System for Locally Advanced Bladder Cancer
Acronym
RTRT-guided radiotherapy for bladder cancer
Scientific Title
Prospective Phase II Study of Image-guided Local Boost Using a Real-time Tumor-tracking Radiotherapy (RTRT) System for Locally Advanced Bladder Cancer
Scientific Title:Acronym
RTRT-guided radiotherapy for bladder cancer
Region
| Japan |
Condition
Condition
bladder cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of definitive RT for locally advanced bladder cancer with an image-guided local boost radiotherapy using fiducial markers and an Real-time Tumor tracking radiotherapy system
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
5-year overall survival
Key secondary outcomes
treatment related toxicity
local control rate
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 | Maneuver |
Interventions/Control_1
implantation of fiducial markers for radiotherapy and image guidance using fiducial markers and Real time tumor tracking radiotherapy system
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
(i) histologically confirmed urothelial cancer
(ii) T2-T4N0M0 with or without hydronephrosis
(iii) WHOperformance status 0-2
(iv) clinically inoperable or refused surgery
(v) provision of written informed consent.
Key exclusion criteria
Patients with tumors that covered all or most of the bladder wall and patients with small cell carcinoma were excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Shirato |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Radiation Medicine
Zip code
Address
North 15 West 7, Kita-Ku, Sapporo, Hokkaido, Japan
TEL
+81-11-706-5977
shirato@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Shimizu |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Radiation Oncology
Zip code
Address
North 15 West 7, Kita-Ku, Sapporo, Hokkaido, Japan
TEL
+81-11-706-5977
Homepage URL
sshing@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Radiation Medicine, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Council for Science and Technology Policy
Ministry of Health, Labour, and Welfare in Japan
Organization
Division
Category of Funding Organization
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
北海道大学病院(北海道)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3880146/?tool=pmcentrez
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
Completed
Date of protocol fixation
| 1999 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 1999 | Year | 04 | Month | 01 | 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 | 04 | Month | 21 | Day |
Last modified on
| 2015 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019976
| 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 |
