UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000020436
Receipt number	R000023505
Scientific Title	Phase I trial of carbon-ion radiotherapy using 12 fractions for primary liver cancer adjacent to the alimentary tract (GUNMA1303)
Date of disclosure of the study information	2016/01/05
Last modified on	2017/09/24 19:54:32

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Basic information

Public title

Phase I trial of carbon-ion radiotherapy using 12 fractions for primary liver cancer adjacent to the alimentary tract (GUNMA1303)

Acronym

Phase I trial of carbon-ion radiotherapy using 12 fractions for primary liver cancer adjacent to the alimentary tract (GUNMA1303)

Scientific Title

Phase I trial of carbon-ion radiotherapy using 12 fractions for primary liver cancer adjacent to the alimentary tract (GUNMA1303)

Scientific Title:Acronym

Phase I trial of carbon-ion radiotherapy using 12 fractions for primary liver cancer adjacent to the alimentary tract (GUNMA1303)

Region

Japan

Condition

Primary liver cancer

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

To evaluate the safety of carbon-ion radiotherapy using 12 fractions for liver cancer adjacent to the alimentary tract.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Dose-limiting toxicity
Acute toxicity

Key secondary outcomes

Response rate
Late toxicity

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

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Carbon-ion radiation therapy
Total dose 60.0-64.8 Gy(RBE)
12 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

20 years-old <=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) pathollogically or clinically diagnosed primary liver tumor (hepatocellular carcinoma or cholangiocellular carcinoma).
2) The distance between taget lesion and digestive tract is 1 cm or less than 1 cm.
3) Satellite nodules (daughter nodules) and/or tumor thrombus are contiguous or adjacent to the main tumor.
4) Tumor is measurable and tumor size is 10 cm or less than 10 cm.
5) Absence of invasion to the main portal vein, common hepatic duct, or inferior vena cava.
6) cN0M0 (accrdiong to UICC(International Union Against Cancer) TMN classification of Malignant tumours 7th edition)
7) At least 4 weeks passed after the previous therapy of hepatectomy, local ablation therapy or TACE.
8) Child-Pugh score of the patient is from 5 points to 9 points.
9) Perfomance status of the patient is from 0 to 2.
8) Child-Pugh score of the patient is from 5 points to 9 points.
9) Expected survival over 6 months.
10) Perfomance status of the patient is from 0 to 2.
11) 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) Invasion to the adjacent organs.
3) Patient with severe comorbidity.

Target sample size

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2016 Year 01 Month 05 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

Completed

Date of protocol fixation

2013 Year 06 Month 06 Day

Date of IRB

Anticipated trial start date

2013 Year 07 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

Management information

Registered date

2016 Year 01 Month 05 Day

Last modified on

2017 Year 09 Month 24 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023505

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name