UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041791 |
|---|---|
| Receipt number | R000047705 |
| Scientific Title | Cross-sectional study of the effectiveness and safety of proton beam therapy for liver metastatic 3 or less lesions in gastric cancer patients without extrahepatic lesion |
| Date of disclosure of the study information | 2020/09/15 |
| Last modified on | 2020/09/14 22:09:43 |
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Basic information
Public title
Cross-sectional study of the effectiveness and safety of proton beam therapy for liver metastatic 3 or less lesions in gastric cancer patients without extrahepatic lesion
Acronym
Cross-sectional study of the effectiveness and safety of proton beam therapy for liver metastatic 3 or less lesions in gastric cancer patients without extrahepatic lesion
Scientific Title
Cross-sectional study of the effectiveness and safety of proton beam therapy for liver metastatic 3 or less lesions in gastric cancer patients without extrahepatic lesion
Scientific Title:Acronym
Cross-sectional study of the effectiveness and safety of proton beam therapy for liver metastatic 3 or less lesions in gastric cancer patients without extrahepatic lesion
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this cross-sectional study was to evaluate the efficacy and safety of proton beam therapy for liver metastatic recurrence in gastric cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Local control rates
2. Overall survival rates
3. Progression-free survival rates
4. Adverse events
Key secondary outcomes
Base
Study type
Observational
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Diagnosed adenocarcinoma after R0 gastrectomy
2.Liver metastasis from gastric cancer patients without extrahepatic metastatic lesions
3.Patients completed proton beam therapy without interruption
Key exclusion criteria
1.Patients without follow-up data
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Fukushima Medical University
Division name
Department of Minimally Invasive Surgical and Medical Oncology
Zip code
960-1295
Address
1 Hikariga-oka, Fukushima City, Fukushima, Japan
TEL
024-547-1111
hisashi.yamaguchi@mt.strins.or.jp
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Southern Tohoku Proton Beam Therapy Center
Division name
Department of radiology
Zip code
963-8052
Address
7-172 Yatsuyamada, Koriyama City, Fukushima, Japan
TEL
024-934-3888
Homepage URL
hisashi.yamaguchi@mt.strins.or.jp
Sponsor or person
Institute
Department of Minimally Invasive Surgical and Medical Oncology, Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Minimally Invasive Surgical and Medical Oncology, Fukushima Medical University
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
Southern Tohoku General Hospital
Address
7-115 Yatsuyamada, Koriyama City, Fukushima, Japan
Tel
024-934-5322
hisashi.yamaguchi@mt.strins.or.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 15 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/32363379/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/32363379/
Number of participants that the trial has enrolled
7
Results
1. The 3-year control rates were 85.7%.
2. The 3-year overall survival rates were 68.6%.
3. The 3-year progression-free survival rates were 43%.
4. No grade >= 3 adverse events were observed.
Results date posted
| 2020 | Year | 09 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 08 | Month | 04 | Day |
Baseline Characteristics
Consecutive patients who underwent Proton Beam Therapy from 2010 to 2015 were isolated from our institutional database. Patients with extrahepatic metastatic lesions were excluded. Seven patients were enrolled.
Participant flow
The median follow-up period was 41.7 months
Adverse events
No grade >= 3 adverse events were observed
Outcome measures
1. The 3-year local control rates　 were 85.7%.
2. The 3-year overall survival rates were 68.6 %.
3. The 3-year progression-free survival rates were 43%.
4. All patients completed proton beam therapy without interruption. No grade >= 3 adverse events were
observed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Consecutive patients who underwent Proton Beam Therapy from 2010 to 2015 were isolated from our institutional database. Patients with extrahepatic metastatic lesions were excluded. Seven patients were enrolled.
Management information
Registered date
| 2020 | Year | 09 | Month | 14 | Day |
Last modified on
| 2020 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047705
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| Registered date | File name |
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