UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032991
Receipt number R000037621
Scientific Title Carbon-ion radiation therapy combined with hepatic arterial infusion chemotherapy for locally advanced hepatocellular carcinoma with tumor thrombosis(GUNMA1801)
Date of disclosure of the study information 2018/06/30
Last modified on 2018/06/14 16:44:35

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Basic information

Public title

Carbon-ion radiation therapy combined with hepatic arterial infusion chemotherapy for locally advanced hepatocellular carcinoma with tumor thrombosis(GUNMA1801)

Acronym

CCarbon-ion radiation therapy combined with hepatic arterial infusion chemotherapy for locally advanced hepatocellular carcinoma with tumor thrombosis

Scientific Title

Carbon-ion radiation therapy combined with hepatic arterial infusion chemotherapy for locally advanced hepatocellular carcinoma with tumor thrombosis(GUNMA1801)

Scientific Title:Acronym

CCarbon-ion radiation therapy combined with hepatic arterial infusion chemotherapy for locally advanced hepatocellular carcinoma with tumor thrombosis

Region

Japan


Condition

Condition

hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine Radiology Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Efficacy

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I,II


Assessment

Primary outcomes

Overall survival

Key secondary outcomes

Adverse event, Tumor response (response rate, disease control rate), Time-to-local progression,Progression-free survival


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 raidiotherapy
60Gy(RBE)/12fr./3 weeks

Hepatic arterial infusion chemotherapy (HAIC)
day 1: cisplatin 20mg/body + 5FU 250mg/body
day 2-5: cisplatin 10mg/body + 5FU 250mg/body
A total of 2-4 courses before and after C-ion RT (not concurrently)

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 hepatocellular carcinoma.
2) Unfit for resection or liver transplantation
3) Unfit for percutaneous tumor ablation
4) Patients untreated by previous systemic chemotherapy or cisplatin-based transarterial therapy.
5) Patients without previous treatment within four weeks
6) Patients with major portal vein and/or hepatic vein invasion.
7) Patients without extrahepatic metasitasis
8) The maximum tumor is measurable and tumor size is less than 12 cm
9) Patients without direct tumor invasion to adjacent organs
10) ECOG PS: 0-1
11) Child-Pugh score of the patient is from 5 points to 9 points.
12) Absence of uncontrolled ascites and/or pleural effusion.
13) Clinical laboratory data is fulfilled with the criteria
14) 20-year-old or older.
15) The patient is able to understand the explanation of the clinical trial and written informed concent is obtained.

Key exclusion criteria

1) Unfit for hepatic arterial reservoir implantation
2) Active or severe gastro-esophageal varix or bleeding
3) Patients on anti-platelet or anti-coagulation therapy
4) A history of severe allergic reaction to contrast medium or local anesthesia.
5) A history of radiation hypersensitivity
6) Patients with severe co-morbidity

Target sample size

21


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

3-39-15 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 Kei Shibuya

Organization

Gunma University

Division name

Heavy-ion Medical Center

Zip code


Address

3-39-15 Showa, Maebashi, Gunma

TEL

027-220-8378

Homepage URL


Email

shibukei@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

2018 Year 06 Month 30 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

Preinitiation

Date of protocol fixation

2018 Year 04 Month 09 Day

Date of IRB


Anticipated trial start date

2018 Year 06 Month 30 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

2018 Year 06 Month 14 Day

Last modified on

2018 Year 06 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037621


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name