UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000041791
Receipt No. 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 (Ver. 1)

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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
Email 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
Email hisashi.yamaguchi@mt.strins.or.jp

Sponsor
Institute Department of Minimally Invasive Surgical and Medical Oncology, Fukushima Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047705