UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase I/II clinical study of Carbon Ion Radiotherapy using 1 fraction for Liver Metastasis from Colorectal Cancer
Title of the study (Brief title)	Dose escalation study of Carbon Ion Radiotherapy for CLM
Region	Japan

Condition
Condition	Colon cancer liver metastasis
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to identify the optimal dose of single fraction carbon-ion radiotherapy (CIRT) for colorectal cancer liver metastasis.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Acute toxicity and initial tumor response
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	expanded access
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Prescribed heavy-ion beam (carbon-ion beam) dose. Initial dose 36Gy(RBE). Dose escalated until dose limiting toxicity is met.
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	This study included patients who: 1. has colorectal cancer liver metastasis diagnosed by radiological and clinical findings 2. with Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2. 3. had primary colorectal lesions and lymph node metastasis removed totally by surgery (R0 resection) at least 4 weeks prior to enrollment and primary lesions to be histologically proven as CRC 4. have not received chemotherapy for at least 4 weeks prior to enrollment.
Key exclusion criteria	This study excluded patients who: 1. has evident vascular invasion. 2. had prior treatment to the specific lesion, 3. with lesions close to the intestine (less than 5 mm), 4. with uncontrollable ascites, 5. with severe liver damage, 6. with active coexisting malignancy, 7. with extra-hepatic lesions including local recurrence 8. were pregnant.
Target sample size	30

Research contact person
Name of lead principal investigator	Masaru Miyazaki
Organization	Chiba University Graduate School of Medicine
Division name	General surgery
Address	1-8-1 Inohana Chuo-ku Chiba City
TEL	043-222-7171
Email	masaru@iuhw.ac.jp

Public contact
Name of contact person	Hirokazu Makishima
Organization	National Institutes for Quantum and Radiological Sciences and Technology
Division name	National Institutes of Radiological Sciences
Address	4-9-1 Anagawa Inage-ku, Chiba City
TEL	043-206-3306
Homepage URL
Email	makishima.hirokazu@qst.go.jp

Sponsor
Institute	National Institutes for Quantum and Radiological Sciences and Technology
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 06 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 01 Month 20 Day
Anticipated trial start date	2006 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 06 Month 07 Day
Last modified on	2018 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037461