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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002083
Receipt No. R000002540
Scientific Title A randomized controlled trial for the comparison of radiofrequency ablation with and without transcatheter arterial chemoembolization for patients with hepatocellular carcinoma
Date of disclosure of the study information 2009/06/18
Last modified on 2013/04/02

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Basic information
Public title A randomized controlled trial for the comparison of radiofrequency ablation with and without transcatheter arterial chemoembolization for patients with hepatocellular carcinoma
Acronym A randomized controlled trial for the comparison of radiofrequency ablation with and without transcatheter arterial chemoembolization for patients with hepatocellular carcinoma
Scientific Title A randomized controlled trial for the comparison of radiofrequency ablation with and without transcatheter arterial chemoembolization for patients with hepatocellular carcinoma
Scientific Title:Acronym A randomized controlled trial for the comparison of radiofrequency ablation with and without transcatheter arterial chemoembolization for patients with hepatocellular carcinoma
Region
Japan

Condition
Condition hepatocellular carcinoma
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the efficacy of local disease control, the survival benefit, and safety of radiofrequency ablation combined with transcatheter arterial chemoembolization compared to radiofrequency ablation in hepatocellular carcinoma patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Time to recurrence (TTR)
Key secondary outcomes Overall survival (OS)
Safety

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 NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 TACE-RFA group: Transcatheter arterial chemoembolization (TACE) was performed by selectively introducing a microcatheter into the right/left hepatic artery or tumor feeding arteries injecting epirubicin, lipiodol, and gelatin sponge. Within 24 hours after TACE, radiofrequency ablation (RFA) was performed percutaneously using multitined expandable electrodes or internally cooled electrodes.
Interventions/Control_2 RFA group: RFA was performed percutaneously using multitined expandable electrodes or internally cooled electrodes.
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) The HCC diagnoses were confirmed by histological or clinical confirmation (Bruix, et al. Hepatology 2005).
2) Any prior anti-cancer therapy for HCC is exclusionary.
3) Male or female subjects >=20 years old
4) Single HCC, > 3 cm in diameter. Percutaneous radiofrequency ablation can be performed technically under ultrasonic guidance.
5) Laboratory parameters:
WBC < 12,000/mm3
Platelet >= 50,000/mm3
Hemoglobin >=9.5g/dL
AST and ALT <= 5 x upper limit of normal
Total bilirubin < 2.0mg/dL
Serum creatinin <= upper limit of normal
6) Life expectancy of at least 3 months
7) Cirrhotic status of Child-Pugh class A or B, and ECOG performance status of 0-2
8) Voluntary signed and dated written informed consent from all the patients was obtained.
9) Radiological evidence of HCC showing lesion arterial hypervascularity by dynamic contrast-enhanced computed tomography or abdominal angiography
10) Transcatheter arterial embolization can be performed technically
Key exclusion criteria 1) History of any other cancer curatively treated < 3years prior to study entry
2) Uncontrolled ascites or pleural effusion
3) Active clinically serious infection ( > grade 2 NCI)
4) Uncontrolled diabetes mellitus or ileus
5) Having with extrahepatic spread HCC tumors
6) Pregnant or breast-feeding patients
7)Known or suspected allergy to iodine or any agents given in this trial
8) Active coronary artery disease less than 3 months prior to study entry
9) Psychological conditions that may interfere with the patient's compliance and evaluation of the study results
10) Evidence of tumor thrombosis in hepatic veins, portal veins, and/or bile ducts
11) Evidence of arterio-portal shunting in liver

Any condition that is unstable or which
could jeopardize the safety of the subject and their compliance in this study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuaki Tanaka
Organization Yokohama City University Medical Center
Division name Gastroenterological Center
Zip code
Address 4-57, Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email

Public contact
Name of contact person
1st name
Middle name
Last name Manabu Morimoto
Organization Yokohama City University Medical Center
Division name Gastroenterological Center
Zip code
Address 4-57, Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email morimoto@urahp.yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
Gastroenterological Center
Institute
Department

Funding Source
Organization Yokohama Foundation for Advancement of Medical Science
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2009 Year 06 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

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
2005 Year 05 Month 18 Day
Date of IRB
Anticipated trial start date
2005 Year 09 Month 01 Day
Last follow-up date
2009 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 06 Month 16 Day
Last modified on
2013 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002540

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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