UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief title)	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	Hidetoshi Eguchi
Organization	Graduate School of Medicine, Osaka University
Division name	Surgery
Address	Yamadaoka 2-2, E2, Suita, Osaka, JAPAN
TEL	06-6879-3251
Email	heguchi@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	Hiroshi Wada
Organization	Graduate School of Medicine, Osaka University
Division name	Surgery
Address	Yamadaoka 2-2, E2, Suita, Osaka, JAPAN
TEL	06-6879-3251
Homepage URL
Email	hwada98@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Kansai Hepatobiliary Oncology Group (KHBO)
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 03 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012102