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Recruitment status Completed
Unique ID issued by UMIN UMIN000020344
Receipt No. R000023504
Scientific Title A phase I clinical trial of carbon-ion radiotherapy using 4 fractions for hepatocellular carcinoma
Date of disclosure of the study information 2015/12/25
Last modified on 2017/09/24

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Basic information
Public title A phase I clinical trial of carbon-ion radiotherapy using 4 fractions
for hepatocellular carcinoma
Acronym A phase I clinical trial of carbon-ion radiotherapy using 4 fractions
for hepatocellular carcinoma
Scientific Title A phase I clinical trial of carbon-ion radiotherapy using 4 fractions
for hepatocellular carcinoma
Scientific Title:Acronym A phase I clinical trial of carbon-ion radiotherapy using 4 fractions
for hepatocellular carcinoma
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 of carbon-ion radiotherapy using 4 fractions for hepatocellular carcinoma.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Dose-limiting toxicity
Acute toxicity(within 6 months)
Key secondary outcomes Response rate
Late toxicity(6 months or later)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 radiation therapy
Total dose 60.0 Gy(RBE)
4 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) pathollogically or clinically diagnosed hepatocellular carcinoma.
2) The tumor is measurable and tumor size is 3cm or larger and less than 10cm.
3) Absence of major portal vein, inferior vena cava or bile duct invasion.
4) cN0M0 (accrdiong to UICC(International Union Against Cancer) TMN classification of Malignant tumours 7th edition)
5) At least 1 weeks passed after the previous therapy of hepatectomy, local ablation therapy or TACE.
6) Child-Pugh score of the patient is from 5 points to 9 points.
7) Perfomance status of the patient is from 0 to 2.
8) The patient is able to understand the explanation of the clinical trial and written informed concent is obtained.
Key exclusion criteria 1) History of radiation therapy to the lesion of interest.
2) The alimentary tract, major branch of portal vein or major bile duct was adjacent to the target lesion.
3) Patients with any other active malignancies.
4) Patient with severe comorbidity.
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Nakano
Organization Gunma University
Division name Heavy Ion Medical Center
Zip code
Address 3-39-22 Showa, Maebashi, Gunma
TEL 027-220-8378
Email tnakano@med.gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Ohno
Organization Gunma University
Division name Heavy Ion Medical Center
Zip code
Address 3-39-22 Showa, Maebashi, Gunma
TEL 027-220-8378
Homepage URL
Email tohno@gunma-u.ac.jp

Sponsor
Institute Gunma University Heavy Ion Medical Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization MEXT
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 12 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 12 Month 07 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 25 Day
Last modified on
2017 Year 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023504


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