UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020444
Receipt number R000023620
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 2020/07/09 09:16:28

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Basic information

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)

Scientific Title

Multi-center clinical trial of a Carbon-ion radiation therapy for unresectable and local therapy unsuitable hepatocellular carcinoma (J-CROS 1505 LIVER)

Scientific Title:Acronym

Multi-center clinical trial of a Carbon-ion radiation therapy for unresectable and local therapy unsuitable hepatocellular carcinoma (J-CROS 1505 LIVER)

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 the carbon-ion radiation therapy for hepatocellular carcinoma in multi-institutional setting.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

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)


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
60 Gy(RBE) / 4 fractions
60 Gy(RBE) / 12 fractions (adjacent to organ at risk)

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

20 years-old <=

Age-upper limit


Not applicable

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

1st name Tatsuya
Middle name
Last name Ohno

Organization

Gunma University Hospital

Division name

Department of radiation oncology

Zip code

371-8511

Address

3-39-22 Showa, Maebashi, Gunma

TEL

027-220-8378

Email

tnakano@gunma-u.ac.jp


Public contact

Name of contact person

1st name Kei
Middle name
Last name Shibuya

Organization

Gunma University

Division name

Heavy Ion Medical Center

Zip code

371-8511

Address

3-39-15 Showa, Maebashi, Gunma

TEL

027-220-8378

Homepage URL


Email

tohno@gunma-u.ac.jp


Sponsor or person

Institute

Gunma University Heavy Ion Medical Center

Institute

Department

Personal name



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

Gunma University Hospital Clinical Research Review Board

Address

3-39-15 Showa, Maebashi, Gunma

Tel

027-220-7111

Email

nakamurt@gunma-u.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

jRCT1032200036

Org. issuing International ID_1

jRCT

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 10 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

Open public recruiting

Date of protocol fixation

2016 Year 04 Month 28 Day

Date of IRB

2016 Year 04 Month 28 Day

Anticipated trial start date

2016 Year 06 Month 01 Day

Last follow-up date

2027 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 01 Month 05 Day

Last modified on

2020 Year 07 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023620


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name