UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041792 |
|---|---|
| Receipt number | R000047709 |
| Scientific Title | Cross-sectional study of the effectiveness and safety of proton beam therapy for liver metastatic 3 or less lesions in colorectal cancer patients without extrahepatic tumor |
| Date of disclosure of the study information | 2020/09/15 |
| Last modified on | 2022/12/06 15:03:07 |
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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 colorectal cancer patients without extrahepatic tumor
Acronym
Cross-sectional study of the effectiveness and safety of proton beam therapy for liver metastatic 3 or less lesions in colorectal cancer patients without extrahepatic tumor
Scientific Title
Cross-sectional study of the effectiveness and safety of proton beam therapy for liver metastatic 3 or less lesions in colorectal cancer patients without extrahepatic tumor
Scientific Title:Acronym
Cross-sectional study of the effectiveness and safety of proton beam therapy for liver metastatic 3 or less lesions in colorectal cancer patients without extrahepatic tumor
Region
| Japan |
Condition
Condition
Colorectal 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 lesion in colorectal 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 resection of primary site
2) Liver metastasis from colorectal cancer patients without extrahepatic metastatic tumor
3) Patients completed proton beam therapy without interruption
Key exclusion criteria
1) Patients without follow-up data
Target sample size
50
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/36446925/
Publication of results
Unpublished
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36446925/
Number of participants that the trial has enrolled
41
Results
The 1-, 2-, and 3-year LC rates were 76.9%, 54.9%, and 54.9%, respectively. The median LC time was 47.3 months.
The 1-, 2-, and 3-year OS rates were 90.1%, 67.8%, and 61.6%, respectively. The median OS time was 46.5 months.
The 1-, 2-, and 3-year PFS rates were 46.3%,
22.3%, and 16.7%, respectively. The median PFS time was 9.7 months
Results date posted
| 2022 | Year | 12 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 11 | Month | 29 | Day |
Baseline Characteristics
This study included 23 men and 18 women, with a median age of 66 years.
A total of 63 lesions were included in the study. There were four cases in which additional PBT was performed for intrahepatic recurrence after a previous PBT. Two patients underwent additional PBT for one lesion, and two patients underwent additional PBT for two lesions.
Participant flow
The dose and fractionation of PBT were determined according to tumor location and size. Considering the location of the tumor and adjacent organs, we modified the dose per fraction to 2-2.4 GyE for the adjacent GI tract type, 3.2-4 GyE for the adjacent hilar region type, and 6-8GyE for the type with the hepatic periphery area away from the GI tract.
Adverse events
No grade 3 or higher AEs were observed.
Outcome measures
Primary endpoint: 2-year LC rate
Factors that may be related to LC, such as synchronous or metachronous liver metastases, tumor size, fraction size, biologically effective dose (BED10), distance from the lesion to the GI tract, PTV dose (D)98%
BED10, PTV dose (D)2cc BED10, CTV D98%BED10, CTV D2cc BED10, GTV D98%BED10, and GTV D2cc BED10, as well as the presence or absence of prior, concurrent, and post-PBT chemotherapy, were investigated. Since our study included various dose sizes and fractionation schemes, we further calculated the biologically effective dose (BED).
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
| 2020 | Year | 09 | 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 2008 to 2018 were isolated from our institutional database. Patients with extrahepatic metastatic lesions were excluded.
Management information
Registered date
| 2020 | Year | 09 | Month | 14 | Day |
Last modified on
| 2022 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047709
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