UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029495 |
|---|---|
| Receipt number | R000033695 |
| Scientific Title | A study 2 for evaluation of inter-fractional changes in internal organs and its dose distributions for carbon ion radiotherapy |
| Date of disclosure of the study information | 2017/10/16 |
| Last modified on | 2019/12/19 16:06:52 |
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Basic information
Public title
A study 2 for evaluation of inter-fractional changes in internal organs and its dose distributions for carbon ion radiotherapy
Acronym
Evaluation 2 of influence for inter-fractional changes for carbon ion radiotherapy
Scientific Title
A study 2 for evaluation of inter-fractional changes in internal organs and its dose distributions for carbon ion radiotherapy
Scientific Title:Acronym
Evaluation 2 of influence for inter-fractional changes for carbon ion radiotherapy
Region
| Japan |
Condition
Condition
Prostate, pancreatic, or uterine cancer
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate interfractional anatomical changes and dose distributions using CT images acquired in every treatment days.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate tumor movement using CT images acquired on the treatment days and the treatment planning CT images.
To recalculate the CTV coverage (V95%) on the current CT images and compare with the CTV coverage on the treatment planning.
Key secondary outcomes
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Twelve to sixteen times at maximum (three to four times at least) of CT acquisitions and one time of 4 dimensional CT acquisition
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient has a prostate, pancreatic, or uterine cancer, and he/she will receive carbon ion radiotherapy.
The treatment fractions is twelve to sixteen.
ECOG Perfomance Status (PS)=0-2.
Over 20 years.
It is possible to get his/her agreement of this study by text.
Key exclusion criteria
Not emergency irradiation case.
Inappropriate case determined by doctor.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Nakano |
Organization
Graduate School of Medicine, Gunma University
Division name
Radiation Oncology
Zip code
Address
3-39-22, Showa-Machi, Maebashi, Gunma
TEL
027-220-8380
tnakano@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Ohno |
Organization
Gunma University
Division name
Heavy Ion Medical Center
Zip code
Address
3-39-22, Showa-Machi, Maebashi, Gunma
TEL
027-220-8378
Homepage URL
tohno@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Heavy Ion Medical Center
Institute
Department
Personal name
Funding Source
Organization
Gunma University Heavy Ion Medical Center
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
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
| 2017 | Year | 10 | Month | 16 | 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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 10 | Day |
Last modified on
| 2019 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033695
