UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000774 |
|---|---|
| Receipt number | R000000933 |
| Scientific Title | Multicenter Phase II Randomized Controlled Trial of S-1 and Interferon-alpha Combined Chemotherapy or S-1 Alone in Advanced Hepatocellular Carcinoma with Extrahepatic Metastasis |
| Date of disclosure of the study information | 2007/07/26 |
| Last modified on | 2011/02/28 17:40:09 |
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Basic information
Public title
Multicenter Phase II Randomized Controlled Trial of S-1 and Interferon-alpha Combined Chemotherapy or S-1 Alone in Advanced Hepatocellular Carcinoma with Extrahepatic Metastasis
Acronym
Randomized Phase II Trial of S-1 and Interferon-alpha or S-1 Alone in Metastatic Hepatocellular Carcinoma
Scientific Title
Multicenter Phase II Randomized Controlled Trial of S-1 and Interferon-alpha Combined Chemotherapy or S-1 Alone in Advanced Hepatocellular Carcinoma with Extrahepatic Metastasis
Scientific Title:Acronym
Randomized Phase II Trial of S-1 and Interferon-alpha or S-1 Alone in Metastatic Hepatocellular Carcinoma
Region
| Japan |
Condition
Condition
Advanced hepatocellular carcinoma with extrahepatic metastasis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this phase II trial is to compare the efficacy and safety of S-1 and Interferon-alpha combined chemotherapy with that of S-1 alone for advanced hepatocellular carcinoma with extrahepatic metastasis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Overall Survival
Key secondary outcomes
Clinical Response (anti-tumor effect)
Progression Free Survival
Incidence of Adverse Event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
S-1 80mg/m2 per os day1~28
and no administration day29~42
for 1 course
Treatment repeats every 42 days
for 2-6 courses
Interventions/Control_2
S-1 80mg/m2 per os day1~28
IFN-alpha 5 million units sc
3 times a week for 4 weeks
and no administration day29~42
Treatment repeats every 42 days
for 2-6 courses
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 proven or clinically diagnosed hepatocellular carcinoma in primary lesion.
2) At least one measurable extrahepatic lesion.
3) Well controlled intrahepatic lesion, if any.
4) No prior treatment for extrahepatic lesion.
5) Child-Pugh score A or B
6) ECOG performance status of 0-1
7) Ability to take medications orally.
8) Age 20-80
9) Adequate organ and marrow function listed below.
1.White blood cell(WBC): 3,000<=WBC<12,000/uL
2.Absolute neutrophil count(Neu): Neu >=1,500/uL
3.Hemoglobin(Hb): Hb>=9.0g/dL
4.Platelet count(Plt): Plt>=70,000/uL
5.Total Bilirubin(T-Bil): T-Bil<=1.5mg/dL
6.AST: AST<=150IU/L
7.ALT: ALT<=150IU/L
8.Serum creatinine(Cr): Cr<=1.2mg/dL
9.Serum albumin(Alb): Alb>=2.8g/dL
10) Life expectancy at least 6 months.
11) Written informed consent.
Key exclusion criteria
1) Histologically diagnosed combined type of hepatocellular carcinoma and cholangiocellular carcinoma in primary lesion.
2) Radiographic evidence of portal vein tumor thrombus in major branch or first branches (Vp3 or Vp4 in the liver cancer study group of Japan.)
3) Radiographic evidence of vascular invasion in hepatic vein or hepatic artery or bile duct.
4) Known bone metastasis.
5) Known brain metastasis.
6) Hepatic encephalopathy.
7) Active infectious disease.
8) Other severe concomitant disease or medical conditions.
9) Chronic diarrhea or any disorder that will limit adequate absorption of S-1.
10) Other malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ, from which the patient has been disease-free for 5 years.
11) Pregnant or lactating women.
12) Concurrent systemic chemotherapy.
13) Any contraindication for S-1 medication.
14) Any contraindication for interferon-alpha administration.
15) Inappropriate patients for entry on this trial in the judgement of the investigator.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Morito Monden |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Surgery
Zip code
Address
2-2, Yamadaoka E-2, Suita 565-0871 Osaka, Japan
TEL
06-6879-3251
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Nagano |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Surgery
Zip code
Address
2-2, Yamadaoka E-2, Suita 565-0871 Osaka, Japan
TEL
06-6879-3251
Homepage URL
Sponsor or person
Institute
Graduate School of Medicine, Osaka University
Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2007 | Year | 07 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2007 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 05 | 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
| 2007 | Year | 07 | Month | 25 | Day |
Last modified on
| 2011 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000933
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