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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021558
Receipt No. R000024858
Official scientific title of the study A Phase II Clinical Trial of Carbon-Ion Therapy for Hepatocellular Carcinoma
Date of disclosure of the study information 2016/03/24
Last modified on 2017/09/21

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Basic information
Official scientific title of the study A Phase II Clinical Trial of Carbon-Ion Therapy for Hepatocellular Carcinoma
Title of the study (Brief title) Carbon-ion radiotherapy for hepatocytecarcinoma (iROCK-1601LI)
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 efficacy and safety of carbon-ion radiotherapy for patients with hepatocellular carcinoma in Kanagawa Cancer Center
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Local control rate at 3 years
Key secondary outcomes 1) Disease-specific survival
2) Overall survival
3) Adverse event rate
4) Event rate for radiation induced liver disease (RILD)

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
Device,equipment
Interventions/Control_1 Carbon-ion radiotherapy (C-RT)
A total dose of 48.0 Gy(RBE)/2Fr or 60.0 Gy(RBE)/4Fr will be administered. C-RT with 60Gy(RBE)/12Fr will be performed if the subject shows the distance equal to or less than 10mm between main portal vein, the first branch of portal vein, gastrointestinal duct and the lesion targeted.
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) Clinically diagnosed as hepatocellular carcinoma (HCC) by dynamic CT or MRI, or histologically diagnosed HCC
2) No past history of radiotherapy for target lesion
3) Single lesion without extrahepatic lesions or HCC with controlled lesions except for the target
4) Measurable lesion on clinical image studies
5) No invasion for main trunk of the portal vein, common bile duct or inferior vena cava
6) 20 years or older of the age at informed consent
7) 0 or 2 of ECOG performance status
8) A or B of Child-Pugh Classification (Score 9 or below)
9) No pleural effusion or ascites which is not controlled
10) Clinical laboratory data is fulfilled with the following criteria
(a) 1,500 /mm3 or higher and 10,000/mm3 or less of white blood cells on complete blood count
(b) 30,000 /mm3 or higher of platelet count
(c) 7.0 g/dL or higher of hemoglobin
(d) 3.0 mg/dL or less of serum total bilirubin
11) Informed consent given with document
Key exclusion criteria 1) Active double cancer
2) Past history of radiotherapy for the target lesion
3) Patient with gastroesophageal varix should be treated
4) 38 degrees celsius or higher of fever, except for tumor fever, or infection which requires systemic therapy
5) Pregnant women, women who may become pregnant, women who deliver with 28 days or lactating women
6) Patient who is difficult to participate this study due to psychiatric condition, uncontrolled heart disease or severe pulmonary disease
7) Patient who is not suitable to participate this study in accordance with physician's examination
Target sample size 50

Research contact person
Name of lead principal investigator Dr. Takuma Nomiya
Organization Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name Ion-beam Radiation Oncology Center
Address 2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL 045-520-2222
Email tnomiya@kcch.jp

Public contact
Name of contact person Dr. Takuma Nomiya
Organization Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name Ion-beam Radiation Oncology Center
Address 2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL 045-520-2222
Homepage URL
Email tnomiya@kcch.jp

Sponsor
Institute Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
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 Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 03 Month 24 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 03 Month 16 Day
Anticipated trial start date
2016 Year 03 Month 24 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
2016 Year 03 Month 22 Day
Last modified on
2017 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024858


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