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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032991
Receipt No. 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

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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
Institute Gunma University Heavy-ion Medical Center
Institute
Department

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
URL(English) https://upload.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


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