UMIN-CTR Clinical Trial

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

Condition
Condition	A case without informed consent for SURF-RCT among primary hepatocellular carcinoma cases 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	Not applicable

Assessment
Primary outcomes	Overall survival Recurrence-free survival
Key secondary outcomes	Types of recurrence Therapeutic choice for primary recurrence

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	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	1000

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 Univesrsity 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

Funding Source
Organization	A grant-in-aid for Scientific Research from the Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Government offices of other countries
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	A prospective non-randomized cohort study. Either liver resection or RFA will be done for hepatocellular carcinoma in an eligible patient. The long-term outcomes will be evaluated.

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/icdr_e/ctr_view.cgi?recptno=R000002166