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Recruitment status Completed
Unique ID issued by UMIN UMIN000020441
Receipt No. R000023610
Official scientific title of the study Multicenter retrospective observational study of carbon-ion radiation therapy for hepatocellular carcinoma (J-CROS 1504)
Date of disclosure of the study information 2016/01/05
Last modified on 2016/01/14

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Basic information
Official scientific title of the study Multicenter retrospective observational study of carbon-ion radiation therapy for hepatocellular carcinoma (J-CROS 1504)
Title of the study (Brief title) Multicenter retrospective observational study of carbon-ion radiation therapy for hepatocellular carcinoma (J-CROS 1504)
Region
Japan

Condition
Condition hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology
Adult
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the safety and efficacy of carbon-on radiation therapy in Japanese institutions for hepatocellular carcinoma retrospectively
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival
Key secondary outcomes Local control rate, Acute and rate toxicity (within 3 months and 3 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 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

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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Pathollogically or clinically diagnosed hepatocellular carcinoma.
2) All lesions were included in the single radiation field.
3) Treated by hypofractionated treatment course.(Patients treated by more than 4 fractions are analysed separately)
4) Tumor size is Measurable.
5) cN0M0 (accrdiong to UICC(International Union Against Cancer) TMN classification of Malignant tumours 7th edition)
6) Patients without any other active malignancies.
7) Absence of uncontrolled ascites
8) Child-Pugh score of the patient is from 5 points to 9 points.
9) Perfomance status of the patient is from 0 to 2.
10) Written informed concent is obtained.
Key exclusion criteria 1) History of radiation therapy to the lesion of interest.
2) Presence of major portal or hepatic vein invasion.
3) History of hepatocellular carcinoma in except for the lesion of interest.
4) Patient with severe comorbidity.
Target sample size 250

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

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

Sponsor
Institute Japan Carbon-ion Radiation Oncology Study Group (J-CROS)
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
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
2016 Year 01 Month 05 Day

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 04 Month 01 Day
Anticipated trial start date
2015 Year 05 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 Study Design: Nationwide multi-institutional retrospective observational study (Cohort study).
Recruitment of patients: All patients who meet all inclusion criteria and not meet any exclusion criteria with hepatocellular carcinoma treated by heavy-ion particle therapy from April 1995 to November 2014 in four institutions which could provide carbon-ion radiation therapy in Japan. Patients who had been included into other clinical trials were excluded.

Management information
Registered date
2016 Year 01 Month 05 Day
Last modified on
2016 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023610


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