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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032911
Receipt No. R000037461
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
Date of disclosure of the study information 2018/06/07
Last modified on 2018/06/07

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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