UMIN-CTR Clinical Trial

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
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/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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047709