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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001795
Receipt No. R000002165
Official scientific title of the study Efficacy of surgery vs. radiofrequency ablation on primary hepatocellular carcinoma: a multicenter randomized controlled trial
Date of disclosure of the study information 2009/04/01
Last modified on 2016/09/29

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Basic information
Official scientific title of the study Efficacy of surgery vs. radiofrequency ablation on primary hepatocellular carcinoma: a multicenter randomized controlled trial
Title of the study (Brief title) Surgery vs. RFA for hepatocellular carcinoma: a randomized controlled trial (SURF-RCT)
Region
Japan

Condition
Condition A primary hepatocellular carcinoma case with tumor foci numbering less than 3, each measuring 3 cm or less, Child-Pugh score of 7 or less, ages between 20 and 79 year, and indications for either surgical resection or radiofrequency ablation for the treatment
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of surgical resection and radiofrequency ablation on primary hepatocellular carcinoma with tumor foci numbering less than 3, each measuring 3 cm or less, and Child-Pugh score of 7 or less.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Overall survival
Recurrence-free survival
Key secondary outcomes Liver function at 1, 3, and 5 years after treatment.
Types of recurrence
Liver function when recurrence is observed
Therapeutic choice for primary recurrence
Incidence of severe adverse events

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Surgical resection as a primary treatment
Interventions/Control_2 Radiofrequency ablation as a primary treatment
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria 1) no preceded treatment
2) tumor foci numbering less than 3 and each measuring 3 cm or less exhibiting typical findings on dynamic CT
3) no extrahepatic lesion or vascular invasion
4) Child-Pugh score of 7 or less
5) tumors which can be curatively treated with both surgery and radiofrequency ablation
6) performance status 0-2
7) bone marrow function and hepatic/renal functions are well maintained
a)White blood cell count: 2000-10000/mm3
b)Platelet count of 50000/mm3 or more
c)Hemoglobin of 8.0g/dL or more
d)Serum total bilirubin of 2.0mg/dL or less
e)Prothronbin time of 50% or more
f)Serum creatinine of 1.5mg/dL or less
g)Blood urea nitrogen of 35mg/dL or less
Key exclusion criteria 1) Double cancer or history of other malignancy within 5 years after diagnosis
2) History of myocardial infarction or unstable angina within 6 months prior to registration
3) Patient with interstitial pneumonia, pneumofibrosis, or severe lung emphysema
4) Patient who cannot undergo enhanced CT scan due to some reason such as allergy for iodized contrast media or renal dysfunction
5) Patient with psychiatric disorder or symptom
6) Pregnant patient or patient with possibility to be pregnant
Target sample size 600

Research contact person
Name of lead principal investigator Norihiro Kokudo
Organization Tokyo University Hospital
Division name Hepato-Biliary-Pancreatic Surgery Division
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411(33321)
Email KOKUDO-2SU@h.u-tokyo.ac.jp

Public contact
Name of contact person Kiyoshi Hasegawa
Organization Tokyo University Hospital
Division name Hepato-Biliary-Pancreatic Surgery Division
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411(33321)
Homepage URL http://www.surftrial.jp
Email kihase-tky@umin.ac.jp

Sponsor
Institute Surgery vs. RFA (SURF) trial group
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization A grant-in-aid for Scientific Research from the Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) Japanese Foundation for Multidisciplinary Treatment of Cancer

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 04 Month 01 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2009 Year 01 Month 26 Day
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2019 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol http://www.surftrial.jp
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2009 Year 03 Month 25 Day
Last modified on
2016 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002165


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