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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028292
Receipt No. R000032391
Scientific Title Evaluation of treatment and long-term outcomes for recurrent hepatocellular carcinoma that was treated by surgery or radiofrequency ablation: a multicenter retrospective observational study (SURF-additional study)
Date of disclosure of the study information 2017/07/20
Last modified on 2017/07/20

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Basic information
Public title Evaluation of treatment and long-term outcomes for recurrent hepatocellular carcinoma that was treated by surgery or radiofrequency ablation: a multicenter retrospective observational study (SURF-additional study)
Acronym Evaluation of recurrent hepatocellular carcinoma: a multicenter retrospective observational study (SURF-additional study)
Scientific Title Evaluation of treatment and long-term outcomes for recurrent hepatocellular carcinoma that was treated by surgery or radiofrequency ablation: a multicenter retrospective observational study (SURF-additional study)
Scientific Title:Acronym Evaluation of recurrent hepatocellular carcinoma: a multicenter retrospective observational study (SURF-additional study)
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 The database of SURF trial (Efficacy of surgery vs. radiofrequency ablation on primary hepatocellular carcinoma: a multicenter randomized controlled trial, UMIN000001795) is used.
The aim of the study is to evaluate treatment for recurrent hepatocellular carcinoma that was treated by surgery or radiofrequency ablation and to evaluate clinical value of tumor marker for recurrent hepatocellular carcinoma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Recurrence-free survival
Key secondary outcomes 1. Treatment selection after recurrence of hepatocellular carcinoma
2. Recurrence pattern
3. Tumor maker trend

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 1090

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Kokudo
Organization National Center for Global Health and Medicine
Division name Department of Surgery
Zip code
Address 1-21-1, Toyama, Shinjuku-ku, Tokyo, JAPAN
TEL 03-3202-7181
Email nkokudo@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshikuni Kawaguchi
Organization The University of Tokyo Hospital
Division name Division of Hepato-Biliary-Pancreatic Surgery
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411
Homepage URL http://www.surftrial.jp
Email yokawaguchi-tky@umin.ac.jp

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

Funding Source
Organization Public Health Research Foudnation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2017 Year 07 Month 20 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 Preinitiation
Date of protocol fixation
2017 Year 01 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information N.A.

Management information
Registered date
2017 Year 07 Month 20 Day
Last modified on
2017 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032391

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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