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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033297
Receipt No. R000037954
Official scientific title of the study 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 2018/07/05

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Basic information
Official scientific title of the study Efficacy of microwave ablation (MWA) vs. radio frequency ablation (RFA) on primary hepatocellular carcinoma: a randomized controlled trial
Title of the study (Brief title) 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 Katsutoshi Sugimoto
Organization Tokyo Medical University
Division name Dept. of Gastroenterology and Hepatology
Address 6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo
TEL 03-3342-6111
Email sugimoto@tokyo-med.ac.jp

Public contact
Name of contact person Katsutoshi Sugimoto
Organization Tokyo Medical University
Division name Dept. of Gastroenterology and Hepatology
Address 6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo
TEL 03-3342-6111
Homepage URL
Email sugimoto@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University
Institute
Department

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)

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)

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 06 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 05 Month 28 Day
Anticipated trial start date
2018 Year 07 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 05 Day
Last modified on
2018 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037954

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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