UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010425 |
|---|---|
| Receipt number | R000012102 |
| Scientific Title | Randomised phase II study of postoperative hepatic arterial infusion chemotherapy (IFN/5-FU versus low-dose FP) for hepatocellular carcioma with portal vein tumor thrombus. (KHBO1207) |
| Date of disclosure of the study information | 2013/04/05 |
| Last modified on | 2017/04/19 15:48:25 |
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Basic information
Public title
Randomised phase II study of postoperative hepatic arterial infusion chemotherapy (IFN/5-FU versus low-dose FP) for hepatocellular carcioma with portal vein tumor thrombus. (KHBO1207)
Acronym
Random P2 study of postoperative IFN/5-FU vs LFP for HCC with PVTT. (KHBO1207)
Scientific Title
Randomised phase II study of postoperative hepatic arterial infusion chemotherapy (IFN/5-FU versus low-dose FP) for hepatocellular carcioma with portal vein tumor thrombus. (KHBO1207)
Scientific Title:Acronym
Random P2 study of postoperative IFN/5-FU vs LFP for HCC with PVTT. (KHBO1207)
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of postoperative hepatic arterial infusion chemotherapy, interferon/fluorouracil versus low-dose cisplatin/fluorouracil, in patients with hepatocellular carcinoma with portal vein tumor thrombus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
2 years survival proportion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Hepatic Arterial Infusion of 5-fluorouracil combined with systemc administration of Interferon-alpha
Interventions/Control_2
Hepatic Arterial Infusion of 5-fluorouracil and Cisplatin (Low-dose FP)
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) hepatocelular carcinoma with histological or evidence or typical findings by CT or MRI.
2) surgically resetcable tumors with tumor thrombus in first branch or main trunk of portal vein.
3) 20 years old or more.
4) ECOG Performance status of 0 or 1.
5) Life expectancy of at least 6 months at the pre-treatment evaluation.
6) Child-Pugh class A or B.
7) Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements.
WBC >= 2000/uL, Neutrophil >= 1000/uL, Hemoglobin >= 9.0 g/dL, Platelet count >= 75000/uL, Total Bilirubin <= 1.5mg/dl, AST/ALT <= 150 IU/L, Serum creatinine <= 1.2mg/dL, Creatinine clearance >= 60 ml/min
Key exclusion criteria
1) Histological diagnosed combined hepatocellular and cholangiocellular carcinoma.
2) Extrahepatic tumor spread which affects patient's prognosis.
3) Hepatic encephalopathy
4) Active infections except for HBV and HCV.
5) Severee complications (IP, HF, RF, LF, ileus, DM, etc)
6) Active double cancer
7) Pregnancy
8-10) Medication or treatment that may affect to the absorption of drug or pharmacokinetics.
11) others, in the investigator's judgment.
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetoshi Eguchi |
Organization
Graduate School of Medicine, Osaka University
Division name
Surgery
Zip code
Address
Yamadaoka 2-2, E2, Suita, Osaka, JAPAN
TEL
06-6879-3251
heguchi@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Wada |
Organization
Graduate School of Medicine, Osaka University
Division name
Surgery
Zip code
Address
Yamadaoka 2-2, E2, Suita, Osaka, JAPAN
TEL
06-6879-3251
Homepage URL
hwada98@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Kansai Hepatobiliary Oncology Group (KHBO)
Institute
Department
Personal name
Funding Source
Organization
Kansai Hepatobiliary Oncology Group (KHBO)
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 04 | Month | 05 | 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
| 2013 | Year | 03 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 05 | Day |
Last modified on
| 2017 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012102
