UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020571
Receipt number R000023750
Scientific Title Efficacy and safety study of carbon ion radiation therapy using 4 fractions for hepatocellular carcinoma (GUNMA0703)
Date of disclosure of the study information 2016/01/14
Last modified on 2018/01/15 18:35:41

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Basic information

Public title

Efficacy and safety study of carbon ion radiation therapy using 4 fractions for hepatocellular carcinoma (GUNMA0703)

Acronym

Efficacy and safety study of carbon ion radiation therapy using 4 fractions for hepatocellular carcinoma (GUNMA0703)

Scientific Title

Efficacy and safety study of carbon ion radiation therapy using 4 fractions for hepatocellular carcinoma (GUNMA0703)

Scientific Title:Acronym

Efficacy and safety study of carbon ion radiation therapy using 4 fractions for hepatocellular carcinoma (GUNMA0703)

Region

Japan


Condition

Condition

hepatocellular carcinoma

Classification by specialty

Medicine in general Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of carbon-ion radiotherapy using 4 fractions for hepatocellular carcinoma.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

3-year local control rate

Key secondary outcomes

Overall survival
Progression free survival
Response rate
Acute toxicity(within 6 months)
Late toxicity(6 months or later)


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



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) Satellite nodules (daughter nodules) and/or tumor thrombus are contiguous or adjacent to the main tumor.
3) Tumor is measurable and tumor size is 10 cm or less than 10 cm.
4) Absence of invasion to the main branch of portal vein, common hepatic duct, or inferior vena cava.
5) cN0M0 (accrdiong to UICC(International Union Against Cancer) TMN classification of Malignant tumours 7th edition)
6) At least 4 weeks passed after the previous therapy of hepatectomy, local ablation therapy or TACE.
7) No other intrahepatic lesion or at least 2 years passed after the previous curative therapy to other intraheaptic lesions.
8) Perfomance status of the patient is from 0 to 2.
9) Child-Pugh score of the patient is from 5 points to 9 points.
10) The patient is able to understand the explanation of the clinical trial and written informed concent is obtained.

Key exclusion criteria

1) History of radiation therapy to the lesion of interest.
2) The alimentary tract was adjacent to the target lesion.
3) Patients with any other active malignancies.
4) Patient with severe comorbidity.

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Nakano

Organization

Gunma University

Division name

Heavy Ion Medical Center

Zip code


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
Middle name
Last name Tatsuya Ohno

Organization

Gunma University

Division name

Heavy Ion Medical Center

Zip code


Address

3-39-22 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


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



Other administrative information

Date of disclosure of the study information

2016 Year 01 Month 14 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

2011 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 10 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study design:Prospective 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 in Gunma university Heavy ion medical center. Patients who had been included into other clinical trials were excluded.


Management information

Registered date

2016 Year 01 Month 14 Day

Last modified on

2018 Year 01 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023750


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name