UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037399 |
|---|---|
| Receipt number | R000042641 |
| Scientific Title | Gastric cancer hemostasis radiation: retrospective comparison of hepatic DVH in total and partial gastric radiation |
| Date of disclosure of the study information | 2019/07/18 |
| Last modified on | 2020/12/08 11:22:25 |
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Basic information
Public title
Effects of gastric cancer hemostatic irradiation on the liver
Acronym
Effects of gastric cancer hemostatic irradiation on the liver
Scientific Title
Gastric cancer hemostasis radiation: retrospective comparison of hepatic DVH in total and partial gastric radiation
Scientific Title:Acronym
Effect of gastric cancer hemostatic radiation on liver
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison of liver DVHs between whole stomach and partial stomach in radiotherapy for gastric cancer
Advanced gastric cancer may be inoperable due to age and physical strength. At that time, hemostatic radiation has been reported to be useful (1-4). There has been no comparison test in the case of irradiating the entire stomach and in the case of irradiating the partial stomach so far. The reason is that the irradiation method varies from one institution to another because irradiation with only a part of the stomach where cancer is present may result in leaving the radiation treatment field. In our hospital, the whole stomach is irradiated in consideration of the past experience.
When the stomach is widely irradiated, the liver may be often irradiated. In our hospital, the whole stomach is irradiated in all cases. When the partial stomach is irradiated, it is naturally expected that the irradiation dose to the liver is also small. This time we retrospectively look at patients who have been irradiated to the entire stomach. And I make a treatment plan when the partial stomach is irradiated as a dummy plan. Then compare the doses to both livers on a computer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of dose between 2 plans
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients with gastric cancer treated by radiotherapy
Key exclusion criteria
The patients who had abdominal surgery
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Tanaka |
Organization
Asahi University Hospital
Division name
Radiation Oncology
Zip code
5011151
Address
3-23 Hashimoto-cho, Gifu city, Gifu
TEL
0582538001
c.bluered@gmail.com
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Tanaka |
Organization
Asahi University Hospital
Division name
Radiation Oncology
Zip code
5008523
Address
3-23 Hashimoto-cho, Gifu city, Japan
TEL
0582538001
Homepage URL
c.bluered@gmail.com
Sponsor or person
Institute
Asahi University
Institute
Department
Personal name
Funding Source
Organization
Asahi University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahi University
Address
3-23 Hashimoto-cho, Gifu city, Gifu
Tel
0582538001
c.bluered@gmail.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
| 2019 | Year | 07 | Month | 18 | 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
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To compare 2 plans about liver DVHs for gastric cancer
Management information
Registered date
| 2019 | Year | 07 | Month | 17 | Day |
Last modified on
| 2020 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042641
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