UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000033297 |
|---|---|
| Receipt number | R000037954 |
| Scientific Title | Efficacy of microwave ablation (MWA) vs. radio frequency ablation (RFA) on primary hepatocellular carcinoma: a randomized controlled trial |
| Date of disclosure of the study information | 2018/07/06 |
| Last modified on | 2022/02/07 09:30:48 |
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Basic information
Public title
Efficacy of microwave ablation (MWA) vs. radio frequency ablation (RFA) on primary hepatocellular carcinoma: a randomized controlled trial
Acronym
RCT on MWA and RFA for Patients with HCCs
Scientific Title
Efficacy of microwave ablation (MWA) vs. radio frequency ablation (RFA) on primary hepatocellular carcinoma: a randomized controlled trial
Scientific Title:Acronym
RCT on MWA and RFA for Patients with HCCs
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assessment of utility and safety of MWA and RFA for patients with HCC
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Complete response (CR) rate after 2-year from treatment
Key secondary outcomes
Overall survival time, Recurrent-free survival time, Posttreatment 1-, 2-,3-year liver function, Recurrent pattern, Liver function at recurrent time, Severe adverse events rate
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
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Microwave ablation
Interventions/Control_2
Radio frequency ablation
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. Patients with hepatocellular carcinomas (HCCs) which shows typical pattern on HCC by contrast-enhanced CT or MRI, and those of which are up to 4 lesions, each smaller than 4 cm
2. Patients who do not have radiologically extrahepatic metastases and gross vascular invasions
3. Presence or absence of pretreatment is not essential qualification; but it is necessary that at least more than 4 weeks has passed since previous treatment
4. Patients with Child-Pugh score less than or equal to 9
5. Patients who are considered to be curatively performed both MWA and RFA
6. Patients with ECOG performance status of 0 to 2
7. Patients preserved adequate bone morrow, liver and kidney functions, as shown below:
White blood cell: more than or equal to 2,000 /mm3, and/or less than or equal to 10,000 /mm3
Platelet: more than or equal to 50,000 /mm3
Hemoglobin: more than or equal to 8.0 g/dL
Serum total bilirubin: less than or equal to 2.0 mg/dL
Prothrombin time: more than or equal to 50%
Serum creatine: less than or equal to 1.5 mg/dL
BUN: less than or equal to 35 mg/dL
8. More than or equal to 20-year-old, male and female
9. Patients who have obtained agreements for participation in writing
Key exclusion criteria
1. Patients who have active double cancer (synchronous double cancer) or who have metachronous double cancer within five years disease duration: note that carcinoma in situ which is judged to be cure is not included
2. Patients who have diagnosed as myocardial infarction, unstable angina, cardiac failure, and arrhythmia with care within 6 months before registration
3. Patients who have either interstitial pneumonia, pulmonary fibrosis, and emphysema which is thought to be difficult to undergo this trial
4. Patients who have iodine allergies, decline in renal function (serum creatinine>1.5 mg/dL), and cannot undertake contrast-enhanced CT or MRI for any reasons
5. Patients who are judged to be difficult to undergo this clinical trial due to psychiatric disease or psychological symptom
6. Patients who are in pregnancy or probable of pregnancy
7. Besides, patients who are judged as inappropriate for registration by doctor in charge
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Katsutoshi |
| Middle name | |
| Last name | Sugimoto |
Organization
Tokyo Medical University
Division name
Dept. of Gastroenterology and Hepatology
Zip code
1600023
Address
6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo
TEL
0333426111
sugimoto@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Katsutoshi |
| Middle name | |
| Last name | Sugimoto |
Organization
Tokyo Medical University
Division name
Dept. of Gastroenterology and Hepatology
Zip code
1600023
Address
6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo
TEL
0333426111
Homepage URL
sugimoto@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University Ethics Committee
Address
6-7-1 Nishishinjuku Shinjuku-ku, Tokyo
Tel
0333426111
irb@tokyo-med.ac.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
東京医科大学病院（東京都）、東邦大学大橋病院（東京都）、横浜市立大学病院（神奈川県）、聖隷浜松病院（静岡県）、岩手医科大学（岩手県）、武蔵野赤十字病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 06 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 05 | Day |
Last modified on
| 2022 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037954
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