UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028292 |
|---|---|
| Receipt number | 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 | 2022/07/24 20:36:46 |
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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 | Norihiro |
| Middle name | |
| Last name | Kokudo |
Organization
National Center for Global Health and Medicine
Division name
Department of Surgery
Zip code
1138655
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, JAPAN
TEL
03-3202-7181
nkokudo@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Yoshikuni |
| Middle name | |
| Last name | Kawaguchi |
Organization
The University of Tokyo Hospital
Division name
Division of Hepato-Biliary-Pancreatic Surgery
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
http://www.surftrial.jp
yokawaguchi-tky@umin.ac.jp
Sponsor or person
Institute
Surgery vs. RFA (SURF) trial group
Institute
Department
Personal name
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
The University of Tokyo
Address
Hongo 7-3-1, bunkyo-ku, Tokyo
Tel
03-3815-5411
ethics@m.u-tokyo.ac.jp
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
http://www.u-tokyo-hbp-transplant-surgery.jp/dl/file20161026.pdf
Publication of results
Unpublished
Result
URL related to results and publications
Under preparation
Number of participants that the trial has enrolled
503
Results
Under preparation
Results date posted
| 2022 | Year | 07 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with hepatocellular carcinoma who underwent surgery or radiofrequency ablation
Participant flow
The opportunity to opt-out is provided on the web
Adverse events
None
Outcome measures
Prognosis and medical expenditure
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
| 2020 | Year | 12 | Month | 31 | Day |
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
| 2022 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032391
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
