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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN C000000275
Receipt No. R000000348
Scientific Title A phase II study with Tegafur/Uracil and Peg-Interferon after TACE for hepatocelluler carcinoma
Date of disclosure of the study information 2005/11/02
Last modified on 2008/02/12

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Basic information
Public title A phase II study with Tegafur/Uracil
and Peg-Interferon after TACE for hepatocelluler carcinoma
Acronym A phase II study with Tegafur/Uracil
and Peg-Interferon after TACE for hepatocelluler carcinoma
Scientific Title A phase II study with Tegafur/Uracil
and Peg-Interferon after TACE for hepatocelluler carcinoma
Scientific Title:Acronym A phase II study with Tegafur/Uracil
and Peg-Interferon after TACE for hepatocelluler carcinoma
Region
Japan

Condition
Condition Advanced hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical effectiveness
and safety of Peg-Interferon and oral Tegafur/Uracil after TACE as adjuvant therapy for advanced hepatocellular carcinoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Safety profile

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Combination chemotherapy with Peg-Interferon and oral Tegafur/Uracil
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Histologically or clinically confirmed
hepatocellular carcinoma
2)Measurable and hypervascular
hepatocellular carcinoma on contrast CT
3)No indication or resistance hepatic
resection and percutaneous treatment
4)No tumor thrombus in main portal vein
5)Child-Pugh score of A or B
6)Adequate bone marrow function
7)Ages 20years and above,under 80 years
8)Eastern Cooperative Oncology Group
(ECOG) performance status of 0 to 2
9)Written informed consent
Key exclusion criteria 1)Allergic reaction to IFN and/or UFT
2)Positive by prick test of IFN
3)Severe liver damage after TAE
4)Autoimmune disease
5)Depression or mental neuropathic
illness
6)Uncontrolled heart or renal desease
7)Pregnant or nursing
8)Extensive leukopenia or extensive
thrombocytopia
9)Use Sho-saiko-to
10)Other uncontrolled severe illness
11)Other inappropriate patient
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Ueda
Organization Wakayama Medical University
Division name The third department of Internal medicine
Zip code
Address 811-1 Kimiidera, Wakayama city,641-0012,Japan
TEL 073-441-0619
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Ueda
Organization Wakayama Medical University
Division name The third department of Internal Medicine
Zip code
Address 811-1,Kimiidera,Wakayama city, 641-0012,Japan
TEL 073-441-0619
Homepage URL
Email hu11@wakayama-med.ac.jp

Sponsor
Institute The third department of Internal Medicine, Wakayama Medical University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2005 Year 11 Month 02 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
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 Terminated
Date of protocol fixation
2005 Year 09 Month 22 Day
Date of IRB
Anticipated trial start date
2005 Year 10 Month 01 Day
Last follow-up date
2008 Year 01 Month 01 Day
Date of closure to data entry
2008 Year 02 Month 01 Day
Date trial data considered complete
2008 Year 02 Month 01 Day
Date analysis concluded
2008 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 11 Month 02 Day
Last modified on
2008 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000348

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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