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UMIN-CTR Clinical Trial |
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Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000001795 |
Receipt No. | 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 |
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 |
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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 |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 600 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002165 |