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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013537
Receipt No. R000015793
Official scientific title of the study A phase II clinical trial of carbon-ion radiotherapy using 2 fractions for hepatocellular carcinoma smaller than and equal to 30mm
Date of disclosure of the study information 2014/04/01
Last modified on 2016/10/03

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Basic information
Official scientific title of the study A phase II clinical trial of carbon-ion radiotherapy using 2 fractions
for hepatocellular carcinoma smaller than and equal to 30mm
Title of the study (Brief title) A phase II clinical trial of carbon-ion radiotherapy using 2 fractions
for hepatocellular carcinoma smaller than and equal to 30mm
Region
Japan

Condition
Condition hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of carbon-ion radiotherapy using 2 fractions for small hepatocellular carcinoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 3-year local control rate
Key secondary outcomes Overall survival
Cause-specific survival
Normal tissue reaction

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Carbon-ion beam
Total dose 48.0 GyE
2 fractions
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) The patient with single liver tumor diagnosed hepatocellular carcinoma pathollogically or clinically.
2) The tumor is measurable and the maximum diameter of the tumor is smaller than and epual to 30mm.
3) cN0M0 (accrdiong to UICC(International Union Against Cancer) TMN classification of Malignant tumours 7th edition)
4) The Child-Pugh score of the patient is from 5 points to 8 points.
5) Perfomance status of the patient is from 0 to 2.
6) Life expectancy of the patients is longer than one year.
7) The patient is able to understand the explanation of the clinical trial and written informed concent is obtained.
Key exclusion criteria 1) Patient recieved any other therapies for hepatocellular carcinoma within 4 weeks from the first day of the carbon-ion radiotherapy.
2) The alimentary tract is included in and adjacent to the planning target volume.
3) Patient with ascites.
4) Patient with hepatic encephalopathy.
5) Patient with sever paraesophageal varix or portal hypertention.
6) Patient with intractable esophageal or gastric varix.
7) Patients with any other active malignancies.
8) Patients with active and intractable infection at the same position where carbon-ion radiotherapy is planned.
Target sample size 35

Research contact person
Name of lead principal investigator Yoshiyuki Shioyama
Organization SAGA HIMAT foundation
Division name Ion Beam Therapy Center
Address 415 Harakoga-machi, Tosu, Saga 841-0071 Japan
TEL 0942-81-1897
Email shioyama-yoshiyuki@saga-himat.jp

Public contact
Name of contact person Shingo Toyama
Organization SAGA HIMAT foundation
Division name Ion Beam Therapy Center
Address 415 Harakoga-machi, Tosu, Saga 841-0071 Japan
TEL 0942-81-1897
Homepage URL
Email toyama-shingo@saga-himat.jp

Sponsor
Institute SAGA HIMAT foundation
Institute
Department

Funding Source
Organization SAGA HIMAT foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 佐賀国際重粒子線がん治療財団 九州国際重粒子線がん治療センター(佐賀県)

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 01 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2014 Year 03 Month 24 Day
Anticipated trial start date
2014 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
2014 Year 03 Month 27 Day
Last modified on
2016 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015793

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


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