UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013537
Receipt number R000015793
Scientific Title A phase II clinical trial of carbon-ion radiotherapy using 2 fractions for hepatocellular carcinoma smaller than and equal to 30mm
Date of disclosure of the study information 2014/04/01
Last modified on 2019/04/01 08:56:26

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Basic information

Public title

A phase II clinical trial of carbon-ion radiotherapy using 2 fractions
for hepatocellular carcinoma smaller than and equal to 30mm

Acronym

A phase II clinical trial of carbon-ion radiotherapy using 2 fractions
for hepatocellular carcinoma smaller than and equal to 30mm

Scientific Title

A phase II clinical trial of carbon-ion radiotherapy using 2 fractions
for hepatocellular carcinoma smaller than and equal to 30mm

Scientific Title:Acronym

A phase II clinical trial of carbon-ion radiotherapy using 2 fractions
for hepatocellular carcinoma smaller than and equal to 30mm

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 and efficacy of carbon-ion radiotherapy using 2 fractions for small hepatocellular carcinoma.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

3-year local control rate

Key secondary outcomes

Overall survival
Cause-specific survival
Normal tissue reaction


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 beam
Total dose 48.0 GyE
2 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



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) The patient with single liver tumor diagnosed hepatocellular carcinoma pathollogically or clinically.
2) The tumor is measurable and the maximum diameter of the tumor is smaller than and epual to 30mm.
3) cN0M0 (accrdiong to UICC(International Union Against Cancer) TMN classification of Malignant tumours 7th edition)
4) The Child-Pugh score of the patient is from 5 points to 8 points.
5) Perfomance status of the patient is from 0 to 2.
6) Life expectancy of the patients is longer than one year.
7) The patient is able to understand the explanation of the clinical trial and written informed concent is obtained.

Key exclusion criteria

1) Patient recieved any other therapies for hepatocellular carcinoma within 4 weeks from the first day of the carbon-ion radiotherapy.
2) The alimentary tract is included in and adjacent to the planning target volume.
3) Patient with ascites.
4) Patient with hepatic encephalopathy.
5) Patient with sever paraesophageal varix or portal hypertention.
6) Patient with intractable esophageal or gastric varix.
7) Patients with any other active malignancies.
8) Patients with active and intractable infection at the same position where carbon-ion radiotherapy is planned.

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiyuki Shioyama

Organization

SAGA HIMAT foundation

Division name

Ion Beam Therapy Center

Zip code


Address

415 Harakoga-machi, Tosu, Saga 841-0071 Japan

TEL

0942-81-1897

Email

shioyama-yoshiyuki@saga-himat.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shingo Toyama

Organization

SAGA HIMAT foundation

Division name

Ion Beam Therapy Center

Zip code


Address

415 Harakoga-machi, Tosu, Saga 841-0071 Japan

TEL

0942-81-1897

Homepage URL


Email

toyama-shingo@saga-himat.jp


Sponsor or person

Institute

SAGA HIMAT foundation

Institute

Department

Personal name



Funding Source

Organization

SAGA HIMAT foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


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

佐賀国際重粒子線がん治療財団 九州国際重粒子線がん治療センター(佐賀県)


Other administrative information

Date of disclosure of the study information

2014 Year 04 Month 01 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

No longer recruiting

Date of protocol fixation

2014 Year 03 Month 24 Day

Date of IRB

2014 Year 03 Month 24 Day

Anticipated trial start date

2014 Year 04 Month 01 Day

Last follow-up date

2022 Year 03 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

2014 Year 03 Month 27 Day

Last modified on

2019 Year 04 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015793


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name