UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002083 |
|---|---|
| Receipt number | 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 15:10:35 |
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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
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
morimoto@urahp.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Gastroenterological Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002540
