UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013197 |
|---|---|
| Receipt number | R000015387 |
| Scientific Title | Safety test of radiotherapy with Proton beam therapy system |
| Date of disclosure of the study information | 2014/02/21 |
| Last modified on | 2017/04/13 21:46:42 |
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Basic information
Public title
Safety test of radiotherapy with Proton beam therapy system
Acronym
Safety test of Proton beam therapy
Scientific Title
Safety test of radiotherapy with Proton beam therapy system
Scientific Title:Acronym
Safety test of Proton beam therapy
Region
| Japan |
Condition
Condition
Solid tumor
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety of radiotherapy with proton beam therapy system
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Incidence of the early phase adverse invent induced by radiotherapy using Proton beam therapy system
Key secondary outcomes
1) changes in tumor volume
2) changes in tumor marker
3) changes in subjective symptoms or 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
| Device,equipment |
Interventions/Control_1
Proton beam therapy 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
1) Patients with pathologically proved malignant tumor, or pathologically proved benign disease that the effectiveness of X-ray treatment was verified
2) Patients with clinically evident malignant disease
3) Patients with clinically benign disease that the effectiveness of X-ray treatment was verified
4) A well-informed written consent was obtained from the patient (and the person with parental authority if the patient was younger than age 20 years)
5) PS is 0-3 in the criteria of ECOG
Key exclusion criteria
1) with serious active infections in the irradiated sites
2) with severe diabetes that uncontrolled, or treated by using insulin
3) with severe heart disease, or some serious complications, i.e., SLE, Scleroderma, interstitial pneumonia
4) pregnant or likely to be
5) considered that participation in this trial is difficult because of psychiatric symptoms or psychosis
6) the proposed radiation treatment site had been given tolerance dose in the past
7) Patient who cannot be held rest for about 30 minutes, except the patient younger than 20 years old who can be held rest under sedation
8) weight over 135kg
9) unsuitable for enrollment judged by principal investigator
Target sample size
100
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
the Cabinet Office, Government of Japan and the Japan Society for the Promotion of Science (JSPS)
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
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 21 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 02 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 04 | 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
| 2014 | Year | 02 | Month | 19 | Day |
Last modified on
| 2017 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015387
| 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 |
