UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002399 |
|---|---|
| Receipt number | R000002945 |
| Scientific Title | Randomized control study comparing intra-hepatic arterial chemotherapy (IHAC) with sorafenib for advanced hepatocellular carcinoma (ISHCC-RCT) |
| Date of disclosure of the study information | 2009/09/01 |
| Last modified on | 2013/09/02 08:56:36 |
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Basic information
Public title
Randomized control study comparing intra-hepatic arterial chemotherapy (IHAC) with sorafenib for advanced hepatocellular carcinoma (ISHCC-RCT)
Acronym
Randomized control study comparing intra-hepatic arterial chemotherapy (IHAC) with sorafenib for advanced hepatocellular carcinoma (ISHCC-RCT)
Scientific Title
Randomized control study comparing intra-hepatic arterial chemotherapy (IHAC) with sorafenib for advanced hepatocellular carcinoma (ISHCC-RCT)
Scientific Title:Acronym
Randomized control study comparing intra-hepatic arterial chemotherapy (IHAC) with sorafenib for advanced hepatocellular carcinoma (ISHCC-RCT)
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To validate the superiority in survival of intrahepatic arterial chemotherapy compared with sorafenib therapy for intrahepatic advanced hepatocellular carcinoma (multiple and/or vascular invasion)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Progression free survival
Response rate
Tumor control rate
Adverse events
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
A: Sorafenib
Interventions/Control_2
B: intra-hepatic arterial chemotherapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) hepatocellular carcinoma confirmed by dynamic CT or dynamic MRI, or histologically confirmed hepatocellular carcinoma
2) no indication for transplantation, surgical resection, local ablation or transcatheter arterial embolization.
3) Child-Pugh A
4) >=20 years old
5) ECOG Performance Status 0-2
6) oral intake is possible
7) no extrahepatic lesion
8) no preceded chemotherapy (excluded transcatheter arterial embolization or adjuvant chemotherapy)
9) more than one measurable disease
10) Adequate baseline organ function:
neutrophil > 1,500/mm3, hemoglobin >=8.5g/dl, platelets > 75,000/mm3, serum bilirubin <2.0mg/dL, aspartate aminotransferase and alanine aminotransferase <=5 times of the institutional upper limit, serum creatinine <2.0mg/dL
11) written informed consent
12) life expectancy >=3 months
Key exclusion criteria
1) histrogically confirmed combined type hepatocellular carcinoma or sarcomatous change
2) previous therapy for hepatocellular carcinoma within 30 days
3) preceded chemotherapy (excluded transcatheter arterial embolization or adjuvant chemotherapy)
4) inadequate for administration of sorafenib, 5-FU, cisplatin or interferon
5) active double cancer
6) severe complication
7) refractory ascites of pleural effusion
8) inappropriate for entry onto this study in the judgment of the investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Kaneko |
Organization
Kanazawa University Hospital
Division name
Department of Gastroenterology
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2233
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Yamashita |
Organization
Kanazawa University Hospital
Division name
Department of Gastrenterology
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2861
Homepage URL
ytatsuya@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University Hospital
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
金沢大学附属病院（石川県）
愛媛大学附属病院（愛媛県）
鳥取大学附属病院（鳥取県）
千葉大学附属病院（千葉県）
山口大学附属病院（山口県）
大阪大学附属病院（大阪府）
杏林大学附属病院（東京都）
東北大学附属病院（宮城県）
昭和大学附属病院（東京都）
兵庫医科大学附属病院（兵庫県）
近畿大学附属病院（大阪府）
岐阜大学附属病院（岐阜県）
岡山大学附属病院（岡山県）
虎ノ門病院（東京都）
久留米大学附属病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 01 | 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 | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | 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 | 08 | Month | 29 | Day |
Last modified on
| 2013 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002945
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