UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030279 |
|---|---|
| Receipt number | R000033286 |
| Scientific Title | Prediction of stereotactic body radiotherapy for liver tumor using hypoxia imaging |
| Date of disclosure of the study information | 2017/12/06 |
| Last modified on | 2022/12/10 09:10:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prediction of stereotactic body radiotherapy for liver tumor using hypoxia imaging
Acronym
Prediction of liver stereotactic body radiotherapy
Scientific Title
Prediction of stereotactic body radiotherapy for liver tumor using hypoxia imaging
Scientific Title:Acronym
Prediction of liver stereotactic body radiotherapy
Region
| Japan |
Condition
Condition
liver tumors
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish a standard protocol of liver stereotactic radiotherapy and to evaluate the affects of the hypoxic area on the efficacy of stereotactic body radiotherapy for liver tumor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
two-year local control
Key secondary outcomes
overall survival, progression-free survival, local progression-free survival (local control), failure pattern, rate of completion of the treatment, incidence of toxicity, incidence of severe toxicity, volume of focal liver radiation damage and association of radiation-doses, validation among images, treatment planning, and images of image-guided radiotherapy, validation of set-up, intra-fraction, and inter-fraction errors, optimization of radiotherapy to minimize radiation exposure in radiotherapy, evaluation of accuracy of radiotherapy, differences between primary and metastatic liver tumors
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
stereotactic body radiotherapy
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
1 liver tumors (5 cm or less) can receive stereotactic radiotherapy
2 medically inoperable or refusal of surgery
3 Performance status (ECOG) 0-2
4 20 years old or elder
5 written informed consent in the first-person (writing for the first-person on behalf of him/her is permitted)
Key exclusion criteria
1. pregnancy or possible pregnancy
2. existence of severe systematic disease
3. Child-Pugh C
4. medical history of radiotherapy for upper abdomen
5. other (physician's decision)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasumasa |
| Middle name | |
| Last name | Nishimura |
Organization
Kindai University Faculty of Medicine
Division name
Department of Radiation Oncology
Zip code
589-0014
Address
377-2 Ohno-Higashi, Osaka-Sayama, Osaka, Japan.
TEL
072-366-0221
ynishi@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Doi |
Organization
Kindai University Faculty of Medicine
Division name
Department of Radiation Oncology
Zip code
589-0014
Address
377-2 Ohno-Higashi, Osaka-Sayama, Osaka, Japan.
TEL
072-366-0221
Homepage URL
h-doi@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kindai University Faculty of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kindai University Faculty of Medicine
Address
377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan.
Tel
072-366-0221
zizen@med.kindai.ac.jp
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
近畿大学医学部（大阪府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 06 | 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
| 2017 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 27 | Day |
Date of closure to data entry
| 2023 | Year | 11 | Month | 27 | Day |
Date trial data considered complete
| 2023 | Year | 11 | Month | 27 | Day |
Date analysis concluded
| 2025 | Year | 11 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 06 | Day |
Last modified on
| 2022 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033286
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
