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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000445
Receipt No. 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

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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
Email

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
Email makuuchi-tky@umin.ac.jp

Sponsor
Institute Hepato-Biliary-Pancreatic Surgery Division, Tokyo University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000540

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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