UMIN-CTR Clinical Trial

Basic information
Public title	A prospective randomized controlled trial of selective DEB-epiDOX vs. selective conventional TACE for hepatocellular carcinoma focusing on local complete response rate
Acronym	A randomized controlled trial of selective DEB-TACE vs. cTACE for HCC (JIVROSG-1302:PRESIDENT study)
Scientific Title	A prospective randomized controlled trial of selective DEB-epiDOX vs. selective conventional TACE for hepatocellular carcinoma focusing on local complete response rate
Scientific Title:Acronym	A randomized controlled trial of selective DEB-TACE vs. cTACE for HCC (JIVROSG-1302:PRESIDENT study)
Region	Japan

Condition
Condition	Patients with hepatocellular carcinoma who are scheduled to receive selective TACE
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare local complete response of selective TACE with drug eluting beads using epirubicin and selective TACE with gelatine particle and emulsion of lipiodol and epirubicin
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	local complete response rate of treated lesion by selective TACE at 3 month after TACE
Key secondary outcomes	local complete response rate of treated lesion by selective TACE at 1 month after TACE, Adverse events, serious adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	TACE with Drug eluting beads of epirubicin
Interventions/Control_2	TACE with gelatine particle and emulsion of lipiodol and epirubicin
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. No indication for surgical resection, liver transplantation, or local ablation therapy 3. Hypervascular lesion showing enhancement in the early phase on CT or MRI with bolus contrast injection and possible to perform selective TACE 4. No previous treatment for HCC nodules in which TACE is planned 5. Measurable HCC nodules in which TACE is planned 6. Maximum HCC nodule of 5cm or less in which TACE is planned 7. ECOG Performance Status 0-1 8. Child-Pugh A or B 9. Adequate organ function a. T-Bil<=3.0 mg/dL b. AST/ALT within 5 times of upper normal limit or 250 IU/L 10. Age of 20 years or over 11. Written informed consent
Key exclusion criteria	1. Tumor thrombosis in portal vein 2. Extrahepatic metastasis 3. Ruptured HCC nodules in which TACE is planned 4. Extrahepatic feeding arteries for HCC nodules in which TACE is planned 5. Prior surgical reconstruction or endoscopic treatment of the biliary tract 6. Clinically significant refractory ascites or pleural effusion 7. Severe arterio-portal or arterio-venous shunts in the liver 8. Allergy to contrast medium that precludes angiography 9. Previously registered patients in this study 10. Severe, active co-morbidity 11. Pregnancy, nursing women, or women of childbearing potential, and men who are sexually active and not willing or able to use medically acceptable forms of contraception 12. Not eligible because of safety issues judged by investigators
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Yasuaki Middle name Last name Arai
Organization	National Cancer Center Hospital
Division name	Department of Diagnostic Radiology
Zip code	104-0045
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL	03-3542-2511
Email	arai-y3111@mvh.biglobe.ne.jp

Public contact
Name of contact person	1st name Masafumi Middle name Last name Ikeda
Organization	National Cancer Center Hospital East
Division name	Department of hepatobiliary & pancreatic oncology
Zip code	277-8577
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL	04-7133-1111
Homepage URL
Email	masikeda@east.ncc.go.jp

Sponsor
Institute	Japan Interventional Radiology In Oncology Study Group(JIVROSG)
Institute
Department

Funding Source
Organization	National Cancer Center Research and Development Fund
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	National Cancer Center Institutional Review Board
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel	03-3542-2511
Email	NCC_IRBoffice@ml.res.ncc.go.jp

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 03 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	440
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	Main results already published
Date of protocol fixation	2016 Year 01 Month 07 Day
Date of IRB	2016 Year 01 Month 07 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date	2019 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 02 Month 29 Day
Last modified on	2020 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024439