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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002929
Receipt No. R000002881
Scientific Title pilot study of systemic combination therapy with TS-1 and IFN for hepatocellular carcinoma patients with extrahepatic metastases who do not response to systemic combination therapy with TS-1 and cisplatin.
Date of disclosure of the study information 2009/12/22
Last modified on 2013/07/18

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Basic information
Public title pilot study of systemic combination therapy with TS-1 and IFN for hepatocellular carcinoma patients with extrahepatic metastases who do not response to systemic combination therapy with TS-1 and cisplatin.
Acronym TS-1/IFN for HCC patients with metastases who do not response to TS-1/CDDP
Scientific Title pilot study of systemic combination therapy with TS-1 and IFN for hepatocellular carcinoma patients with extrahepatic metastases who do not response to systemic combination therapy with TS-1 and cisplatin.
Scientific Title:Acronym TS-1/IFN for HCC patients with metastases who do not response to TS-1/CDDP
Region
Japan

Condition
Condition hepatocellular carcinoma with extrahepatic metastases
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To elucidate the efficacy of systemic combination therapy with TS-1 and IFN for hepatocellular carcinoma patients with extrahepatic metastases who do not response to systemic combination therapy with TS-1 and cisplatin.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes response rate
Key secondary outcomes 1) overall survival
2) time to progression
3) safety

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 Two weeks represented one cycle of treatment. In each cycle, S-1 was administered orally at a dose of 80-120 mg daily (depending on body surface area: <1.25 m2, 80 mg; 1.25-1.5 m2, 100 mg; &#8805;1.5 m2, 120 mg), and CDDP was administered intravenously at a dose of 60 mg/m2 on day 8. Each treatment cycle was followed by a two-to-four-week rest period of no treatment.
Treatment was repeatec unless HCC reveales progressive disease (acording to RECIST).
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Diagnosis of HCC was confirmed histopathologically or clinically.
2) no adaptation of resection, liver transplantation and local abration.
3) with extrahepatic metastases
4) without uncontrollable ascites
5) without hepatic coma
6) without vascular invasion of HCC
7) PS 0-1
8) chronic hepatitis or Child-Pugh A or B
9)
WBC > 3000/mm3
Plt > 80000/mm3
Hb > 10.0 g/dl
Total Bilirubin < 2.0 mg/dl
Albumin > 3 g/dl
Creatine < 1.2mg/dl
Prothromin time > 60 percentage
Key exclusion criteria 1) With other malignant disease.
2) A pregnant woman, or a woman suspected of pregnancy.
3) With severe infectious disease.
4) With history of severe allergy.
5) With severe renal function disease. 6) With severe allergy for 5FU, TS-1 or IFN.
7) With severe bone marrow supression.
8) With pulmonary fibrosis.
9) With another fluoropyrimidine
10)With flucytosine
9) with shosaikoto
10) with autoimmune hepatitis
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuaki Chayama
Organization Hiroshima University
Division name Department of Medicine and Molecular Science, Division of Frontier Medical Science, Programs for Biomedical Research, Graduate School of Biomedical Sciences
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hiroshima University
Division name Department of Medicine and Molecular Science, Division of Frontier Medical Science, Programs for Bio
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Medicine and Molecular Science, Division of Frontier Medical Science, Programs for Biomedical Research, Graduate School of Biomedical, Hiroshima University
Institute
Department

Funding Source
Organization Department of Medicine and Molecular Science, Division of Frontier Medical Science, Programs for Biomedical Research, Graduate School of Biomedical, Hiroshima University
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
2009 Year 12 Month 22 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
2009 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 12 Month 22 Day
Last modified on
2013 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002881

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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