UMIN-CTR Clinical Trial
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|Recruitment status||Open public recruiting|
|Unique ID issued by UMIN||UMIN000020444|
|Scientific Title||Multi-center clinical trial of a Carbon-ion radiation therapy for unresectable and local therapy unsuitable hepatocellular carcinoma (J-CROS 1505 LIVER)|
|Date of disclosure of the study information||2016/01/10|
|Last modified on||2018/01/06|
|Public title||Multi-center clinical trial of a Carbon-ion radiation therapy for unresectable and local therapy unsuitable hepatocellular carcinoma (J-CROS 1505 LIVER)|
|Acronym||Multi-center clinical trial of a Carbon-ion radiation therapy for unresectable and local therapy unsuitable hepatocellular carcinoma (J-CROS 1505 LIVER)|
|Classification by specialty||
|Classification by malignancy||Malignancy|
|Narrative objectives1||To evaluate the efficacy and safety of the carbon-ion radiation therapy for hepatocellular carcinoma in multi-institutional setting.|
|Basic objectives -Others|
|Developmental phase||Phase II|
|Primary outcomes||Overall survival (Three-year overall survival)|
|Key secondary outcomes||Progression free survival (Three-year), Local progression free survival (Three-year), Adverse event, Incidence of 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.|
|Basic design||Single arm|
|Blinding||Open -no one is blinded|
|No. of arms||1|
|Purpose of intervention||Treatment|
|Type of intervention||
|Interventions/Control_1||Carbon-ion radiation therapy
60 Gy(RBE) / 4 fractions
60 Gy(RBE) / 12 fractions (adjacent to organ at risk)
|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.|
|Gender||Male and Female|
|Key inclusion criteria||1) Histologically or clinically diagnosed primary hepatocellular carcinoma.
2) Untreated and absence of previous local therapy.
3) Solitary tumor without extrahepatic lesions.
4) The tumor is measurable and tumor size is less than 12 cm.
5) Absence of major portal vein and/or hepatic vein.
6) The tumor is in contact with the alimentary tract.
7) Unfit for resection or liver transplantation.
8) Unfit for percutaneous tumor ablation.
9) ECOG PS: 0-2.
10) Child-Pugh score of the patient is from 5 points to 9 points.
11) Absence of uncontrolled ascites and/or pleural effusion.
12) 20-year-old or older.
13) The patient is able to understand the explanation of the clinical trial and written informed concent is obtained.
|Key exclusion criteria||1) Patients with any other active malignancies.
2) Having esophageal varices which are at great risk of bleeding
3) Having active infectious diseases
4) Having a fever greater than 38 degrees Celsius.
5) Having myocardial infarction or angina pectoris within 6 months.
6) Having interstitial pneumonitis, pulmonary fibrosis or severe respiratory disease such as pulmonary emphysema.
7) Having radiation hypersensitivity.
8) Associated with mental illness or manifestation complicating study participation.
9) Being pregnant or possible conception.
10) Miscellaneous inappropriate conditions judged by physicians.
|Target sample size||130|
|Research contact person|
|Name of lead principal investigator||
|Organization||Gunma University Hospital|
|Division name||Department of radiation oncology|
|Address||3-39-22 Showa, Maebashi, Gunma|
|Name of contact person||
|Division name||Heavy Ion Medical Center|
|Address||3-39-15 Showa, Maebashi, Gunma|
|Institute||Gunma University Heavy Ion Medical Center|
|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.
|Category of Funding Organization||Japanese Governmental office|
|Nationality of Funding Organization|
|Other related organizations|
|Name of secondary funder(s)|
|IRB Contact (For public release)|
|Org. issuing International ID_1|
|Org. issuing International ID_2|
|IND to MHLW|
|Other administrative information|
|Date of disclosure of the study information||
|URL releasing protocol|
|Publication of results||Unpublished|
|URL related to results and publications|
|Number of participants that the trial has enrolled|
|Results date posted|
|Results Delay Reason|
|Date of the first journal publication of results|
|Plan to share IPD|
|IPD sharing Plan description|
|Recruitment status||Open public recruiting|
|Date of protocol fixation||
|Date of IRB|
|Anticipated trial start date||
|Last follow-up date|
|Date of closure to data entry|
|Date trial data considered complete|
|Date analysis concluded|
|Other related information|
|Last modified on||
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