UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001795 |
|---|---|
| Receipt number | R000002165 |
| Scientific Title | 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 21:00:52 |
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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
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
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)
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
kihase-tky@umin.ac.jp
Sponsor or person
Institute
Surgery vs. RFA (SURF) trial group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002165
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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