UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of surgery vs. radiofrequency ablation on primary hepatocellular carcinoma: a multicenter randomized controlled trial
Acronym	Surgery vs. RFA for hepatocellular carcinoma: a randomized controlled trial (SURF-RCT)
Scientific Title	Efficacy of surgery vs. radiofrequency ablation on primary hepatocellular carcinoma: a multicenter randomized controlled trial
Scientific Title:Acronym	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	1st name Middle name Last name Norihiro Kokudo
Organization	Tokyo University Hospital
Division name	Hepato-Biliary-Pancreatic Surgery Division
Zip code
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	1st name Middle name Last name Kiyoshi Hasegawa
Organization	Tokyo University Hospital
Division name	Hepato-Biliary-Pancreatic Surgery Division
Zip code
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

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 04 Month 01 Day

Related information
URL releasing protocol	http://www.surftrial.jp
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	2009 Year 01 Month 26 Day
Date of IRB
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

Other
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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002165

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