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UMIN-CTR Clinical Trial |
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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 |
Basic information | ||
Public title | A phase II study with Tegafur/Uracil
and Peg-Interferon after TACE for hepatocelluler carcinoma |
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Acronym | A phase II study with Tegafur/Uracil
and Peg-Interferon after TACE for hepatocelluler carcinoma |
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Scientific Title | A phase II study with Tegafur/Uracil
and Peg-Interferon after TACE for hepatocelluler carcinoma |
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Scientific Title:Acronym | A phase II study with Tegafur/Uracil
and Peg-Interferon after TACE for hepatocelluler carcinoma |
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Region |
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Condition | ||||
Condition | Advanced hepatocellular carcinoma | |||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |