UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004963 |
|---|---|
| Receipt number | R000005908 |
| Scientific Title | A prospective randomized controlled trial of preoperative transarterial chemoembolization of the selective, whole liver or no preoperative transarterial chemoembolization for hepatocellular carcinoma |
| Date of disclosure of the study information | 2011/01/26 |
| Last modified on | 2011/01/26 19:45:58 |
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Basic information
Public title
A prospective randomized controlled trial of preoperative transarterial chemoembolization of the selective, whole liver or no preoperative transarterial chemoembolization for hepatocellular carcinoma
Acronym
Preoperative TACE vs. no preoperative TACE for HCC
Scientific Title
A prospective randomized controlled trial of preoperative transarterial chemoembolization of the selective, whole liver or no preoperative transarterial chemoembolization for hepatocellular carcinoma
Scientific Title:Acronym
Preoperative TACE vs. no preoperative TACE for HCC
Region
| Japan |
Condition
Condition
A primary hepatocellular carcinoma case
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We previously reported that preoperative chemolipiodolization of the whole liver is effective for reducing the incidence of postoperative recurrence and prolonging survival in patients with respectable hepatocellular carcinoma (HCC). We conducted a randomized controlled trial to evaluate the effects of preoperative transcatheter arterial chemoembolization (TACE) on survival after resection of HCC.
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
Preoperative liver function
Types of recurrence
Therapeutic choice for primary recurrence
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Preoperative transarterial chemoembolization of whole liver for hepatocellular carcinoma
Interventions/Control_2
Preoperative transarterial chemoembolization of the selective liver for hepatocelullar carcinoma
Interventions/Control_3
No preoperative transarterial chemoembolization for hepatocellular carcinoma
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)no preceded treatment
2)no extrahepatic lesion or major vascular invasion
3)performance status 0-2
4) 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
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Kaibori |
Organization
Kansai Medical University
Division name
Surgery
Zip code
Address
2-3-1 Shinmachi, Hirakata city, Osaka, Japan
TEL
072-804-0101
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Kaibori |
Organization
Kansai Medical University
Division name
Surgery
Zip code
Address
2-3-1 Shinmachi, Hirakata city, Osaka, Japan
TEL
072-804-0101
Homepage URL
kaibori@hirakatra.kmu.ac.jp
Sponsor or person
Institute
Departement of Surgery, Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
| 2011 | Year | 01 | Month | 26 | 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
There were no serious side effects in either TACE groups and the operative outcome did not differ among the three groups. Even though preoperative TACE induced complete tumor necrosis, no significant difference was observed in the pattern of intrahepatic recurrence or the recurrence time among three groups. There were no significant differences of disease-free survival and overall survival among three groups, even if the patients were stratified with regard to preoperative tumor size.
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
Completed
Date of protocol fixation
| 2003 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 26 | Day |
Last modified on
| 2011 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005908
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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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