UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000275 |
|---|---|
| Receipt number | 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 12:43:34 |
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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
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
hu11@wakayama-med.ac.jp
Sponsor or person
Institute
The third department of Internal Medicine, Wakayama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000348
