UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000445 |
|---|---|
| Receipt number | R000000540 |
| Scientific Title | A randomized controlled trial by a parallel group design in a single institution to evaluate the effectiveness of oral adjuvant chemotherapy using uracil-tegafur to prevent recurrence after curative resection of hepatocellular carcinoma |
| Date of disclosure of the study information | 2006/07/05 |
| Last modified on | 2007/02/04 23:54:40 |
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Basic information
Public title
A randomized controlled trial by a parallel group design in a single institution to evaluate the effectiveness of oral adjuvant chemotherapy using uracil-tegafur to prevent recurrence after curative resection of hepatocellular carcinoma
Acronym
A randomized controlled trial for adjuvant UFT therapy after resection of hepatocelluar carcinoma
Scientific Title
A randomized controlled trial by a parallel group design in a single institution to evaluate the effectiveness of oral adjuvant chemotherapy using uracil-tegafur to prevent recurrence after curative resection of hepatocellular carcinoma
Scientific Title:Acronym
A randomized controlled trial for adjuvant UFT therapy after resection of hepatocelluar carcinoma
Region
| Japan |
Condition
Condition
Cases with hepatocellular carcinoma, which is removed curatively and surgically
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of oral administration of uracil-tegafur as adjuvant chemotherapy to prevent recurrence after resection of hepatocellular carcinoma, by comparing the recurrence-free survivals between surgery alone and surgery with adjuvant therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Recurrence-free survival
Key secondary outcomes
Overall survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of uracil-tegafur (300mg/day) for 1 year after curative resection of hepatocellular carcinoma
Interventions/Control_2
Only follow-up without any anti-cancer and anti-virus therapy after curative resection of hepatocellular carcinoma
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
| 15 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing first curative resection for hepatocellular carcinoma, who met the following entry criteria: cirrhosis of Child-Pugh class A or B; adequate bone marrow and renal functions (white blood cell count >4,000/mm3, platelet count >50,000m3m, and serum creatinine level <1.5 mg/dL)
Key exclusion criteria
The presence of clinically confirmed extrahepatic metastasis, macroscopic evidence of tumor thrombus in the inferior vena cava or the main portal vein, other previous or synchronous malignant disorders, and postoperative dysfunction of any organ
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatoshi Makuuchi |
Organization
Tokyo University Hospital
Division name
Hepato-Biliary-Pancreatic Surgery Division
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5800-8841
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masatoshi Makuuchi |
Organization
Tokyo University Hospital
Division name
Hepato-Biliary-Pancreatic Surgery Division
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5800-8841
Homepage URL
makuuchi-tky@umin.ac.jp
Sponsor or person
Institute
Hepato-Biliary-Pancreatic Surgery Division, Tokyo University Hospital
Institute
Department
Personal name
Funding Source
Organization
The Kanae Foundation for Life & Socio-medical Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
| 2006 | Year | 07 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Hasegawa K, Takayama T, Ijichi M, Matsuyama Y, Imamura H, Sano K, Sugawara Y, Kokudo N, Makuuchi M. Uracil-tegafur as an adjuvant for hepatocellular carcinoma: a randomized trial. Hepatology 2006; 44: 891-895
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
| 1997 | Year | 06 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 1997 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2005 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2005 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2005 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2005 | Year | 08 | Month | 01 | Day |
Other
Other related information
ICH-GCP was completely applied from 1998, and the institutional system based on ICH-GCP including IRB also began to be active in Tokyo University Hospital in 1998. In 1997 when we conducted our trial, we thoroughly examined the protocol in our group meeting, because no IRB based on ICH-GCP was available. After that, this study was started without review of the protocol by IRB.
Management information
Registered date
| 2006 | Year | 07 | Month | 05 | Day |
Last modified on
| 2007 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000540
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| Registered date | File name |
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