UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003917 |
|---|---|
| Receipt number | R000004440 |
| Scientific Title | Randomised phase 2 trial of hepatic arterial chemotherapy with cisplatin and 5-FU versus sorafenib in patients with advanced unresectable hepatocellulare carcinoma |
| Date of disclosure of the study information | 2010/07/15 |
| Last modified on | 2014/01/15 15:03:10 |
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Basic information
Public title
Randomised phase 2 trial of hepatic arterial chemotherapy with cisplatin and 5-FU versus sorafenib in patients with advanced unresectable hepatocellulare carcinoma
Acronym
Evaluation of clinical effects of NFP therapy and sorafenib for advanced HCC
Scientific Title
Randomised phase 2 trial of hepatic arterial chemotherapy with cisplatin and 5-FU versus sorafenib in patients with advanced unresectable hepatocellulare carcinoma
Scientific Title:Acronym
Evaluation of clinical effects of NFP therapy and sorafenib for advanced HCC
Region
| Japan |
Condition
Condition
unresectable advanced hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy of intra-arterial combination therapy ofcisplatin suspension in lipiodol and 5-FU for patients with unresectable advanced hepatocellular carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
time to progression
therapeutic efficacy
Key secondary outcomes
overall survival
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
5-FU+CDDP with lipiodol
Interventions/Control_2
sorafenib
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) unresectable HCC
2) Child-Pugh class A
3) Performance status: ECOG 0-1
4) no influence of prior therapy
5) Serum creatinine; less than 1.5 mg/dl,
WBC: more than 2000, Total bilirubine: less than 2 mg/dl , no uncontrolable ascites, no hepatic encephalopathy, Platelet: more than 50,000, Hb: more than 8.5 g/dl,
Key exclusion criteria
1) extrahepatic metastasis
2) pregnant woman
3) drug allergy
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio Sata |
Organization
Kurume University, School od Medicine,
Division name
Department of Medicine, Division of Gastroenterology
Zip code
Address
67 Asahi-machi, Kurume City, Japan
TEL
0942-31-7561
tori@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuji Torimura |
Organization
Kurume University, School od Medicine
Division name
Department of Medicine, Division of Gastroenterology
Zip code
Address
67 Asahi-machi, Kurume City, Japan
TEL
0942-31-7561
Homepage URL
tori@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University, School od Medicine Department of Medicine, Division of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Kurume University, School od Medicine Department of Medicine, Division of Gastroenterology
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
久留米大学病院(福岡県)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | 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
| 2010 | Year | 07 | Month | 15 | Day |
Last modified on
| 2014 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004440
