Back to resultsP2 Study of Postoperative Interferon/Fluorouracil vs Cisplatin/Fluorouracil for Hepatocellular Carcinoma.
Primary Purpose
Hepatocellular Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Interferon Alfa、Fluorouracil
Cisplatin、Fluorouracil
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- hepatocellular carcinoma with histological or evidence or typical findings by CT or MRI.
- surgically resectable tumors with tumor thrombus in first branch or main trunk of portal vein.
- 20 years old or more.
- Eastern Cooperative Oncology Group Performance status of 0 or 1.
- Life expectancy of at least 6 months at the pre-treatment evaluation.
- Child-Pugh class A or B.
- Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements.
white blood cell count >= 2000/microliter, Neutrophil >= 1000/microliter, Hemoglobin >= 9.0 g/dL, Platelet count >= 75000/microliter, Total Bilirubin <= 1.5mg/dl, aspartate aminotransferase(AST) /alanine aminotransferase(ALT) <= 150 IU/L, Serum creatinine <= 1.2mg/dL, Creatinine clearance >= 60 ml/min
-
Exclusion Criteria:
- Histological diagnosed combined hepatocellular and cholangiocellular carcinoma.
- Extrahepatic tumor spread which affects patient's prognosis.
- Hepatic encephalopathy
- Active infections except for hepatitis B virus(HBV) and hepatitis C virus(HCV).
- Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on)
- Active double cancer
- Pregnancy 8-10) Medication or treatment that may affect to the absorption of drug or pharmacokinetics.
11) others, in the investigator's judgment.
-
Sites / Locations
- Osaka University, Graduate School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Interferon Alfa、Fluorouracil
Cisplatin、Fluorouracil
Arm Description
Interferon Alfa 5×10⁶International Unit(IU)/body subcutaneously 3 times a week for 4 weeks Fluorouracil 300mg/m2, day1-5,8-12, every 6 weeks
Cisplatin 20mg/m2 ,day1,8,22,29, every 6 weeks Fluorouracil 300mg/m2, day1-5,8-12,22-26,29-33, every 6 weeks
Outcomes
Primary Outcome Measures
Two-year overall survival rate
Duration: From randomization to evidenced death.
Rate: Number of patients with evidenced death / number of total patients.
2 year survival rate: survival rate at two-year from the randomization
Secondary Outcome Measures
Progression free survival time
Progression free survival time from randomization to tumor progression based on RECIST or recurrence after curative surgery was calculated by Kaplan Meier methods.
Overall survival time
Overall survival time from randomization to evidence death was calculated by Kaplan Meier methods.
toxicity
The incidence of adverse events evaluated by CTCAE Ver4.0.
Full Information
NCT ID
NCT01834963
First Posted
April 16, 2013
Last Updated
May 15, 2018
Sponsor
Kansai Hepatobiliary Oncology Group
1. Study Identification
Unique Protocol Identification Number
NCT01834963
Brief Title
P2 Study of Postoperative Interferon/Fluorouracil vs Cisplatin/Fluorouracil for Hepatocellular Carcinoma.
Official Title
Randomised Phase II Study of Postoperative Hepatic Arterial Infusion Chemotherapy (Interferon/Fluorouracil Versus Low-dose Cisplatin/Fluorouracil) for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kansai Hepatobiliary Oncology Group
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
No standard treatment has been established for highly advanced hepatocellular carcinoma (HCC) invading the major branches of the portal vein except for sorafenib. Some reports suggested that hepatic arterial infusion chemotherapy improved survival of these patients. Other reports indicated surgical intervention improved that survival. However, there is no standard adjuvant therapy after liver resection for the patients with HCC with portal vein tumor thrombus in the main or first branch of the portal vein. Our preliminary results showed that combined interferon-alpha and intra-arterial 5-fluorouracil (5-FU) as a postoperative therapy prolonged disease-free and overall survival after liver resection. Hepatic arterial infusion chemotherapy using low-dose 5-FU and cisplatin is also promising regimen for advanced HCC.
Herein, the investigators planed the study to evaluate efficacy (two year survival as primary outcome, and overall-survival as secondary outcome) and safety ( as secondary outcome) in hepatic arterial infusion chemotherapy with continuous infusion of 5-fluorouracil and systemic administration of interferon-alpha or low-dose 5-FU and cisplatin, and to compare the efficacy as randomized control trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interferon Alfa、Fluorouracil
Arm Type
Experimental
Arm Description
Interferon Alfa 5×10⁶International Unit(IU)/body subcutaneously 3 times a week for 4 weeks
Fluorouracil 300mg/m2, day1-5,8-12, every 6 weeks
Arm Title
Cisplatin、Fluorouracil
Arm Type
Experimental
Arm Description
Cisplatin 20mg/m2 ,day1,8,22,29, every 6 weeks
Fluorouracil 300mg/m2, day1-5,8-12,22-26,29-33, every 6 weeks
Intervention Type
Drug
Intervention Name(s)
Interferon Alfa、Fluorouracil
Other Intervention Name(s)
Interferon Alfa ; IFN、, Fluorouracil ; 5-FU
Intervention Description
Hepatic Arterial Infusion of 5-fluorouracil combined with systemic administration of Interferon-alpha
Interferon Alfa 5×10⁶International Unit(IU)/body subcutaneously 3 times a week for 4 weeks
Fluorouracil 300mg/m2, day1-5,8-12, every 6 weeks
Intervention Type
Drug
Intervention Name(s)
Cisplatin、Fluorouracil
Other Intervention Name(s)
Cisplatin ； Cispulan, Fluorouracil ; 5-FU
Intervention Description
Hepatic Arterial Infusion of 5-fluorouracil and Cisplatin (Low-dose FP)
Cisplatin 20mg/m2 ,day1,8,22,29, every 6 weeks
Fluorouracil 300mg/m2, day1-5,8-12,22-26,29-33, every 6 weeks
Primary Outcome Measure Information:
Title
Two-year overall survival rate
Description
Duration: From randomization to evidenced death.
Rate: Number of patients with evidenced death / number of total patients.
2 year survival rate: survival rate at two-year from the randomization
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Progression free survival time
Description
Progression free survival time from randomization to tumor progression based on RECIST or recurrence after curative surgery was calculated by Kaplan Meier methods.
Time Frame
two years
Title
Overall survival time
Description
Overall survival time from randomization to evidence death was calculated by Kaplan Meier methods.
Time Frame
two years
Title
toxicity
Description
The incidence of adverse events evaluated by CTCAE Ver4.0.
Time Frame
At the end of hepatic arterial infusion chemotherapy (6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
hepatocellular carcinoma with histological or evidence or typical findings by CT or MRI.
surgically resectable tumors with tumor thrombus in first branch or main trunk of portal vein.
20 years old or more.
Eastern Cooperative Oncology Group Performance status of 0 or 1.
Life expectancy of at least 6 months at the pre-treatment evaluation.
Child-Pugh class A or B.
Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements.
white blood cell count >= 2000/microliter, Neutrophil >= 1000/microliter, Hemoglobin >= 9.0 g/dL, Platelet count >= 75000/microliter, Total Bilirubin <= 1.5mg/dl, aspartate aminotransferase(AST) /alanine aminotransferase(ALT) <= 150 IU/L, Serum creatinine <= 1.2mg/dL, Creatinine clearance >= 60 ml/min
-
Exclusion Criteria:
Histological diagnosed combined hepatocellular and cholangiocellular carcinoma.
Extrahepatic tumor spread which affects patient's prognosis.
Hepatic encephalopathy
Active infections except for hepatitis B virus(HBV) and hepatitis C virus(HCV).
Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on)
Active double cancer
Pregnancy 8-10) Medication or treatment that may affect to the absorption of drug or pharmacokinetics.
11) others, in the investigator's judgment.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroaki Nagano, MD, PhD
Organizational Affiliation
Osaka University Graduate School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Osaka University, Graduate School of Medicine
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroshi Wada
Phone
+81-6-6879-3251
12. IPD Sharing Statement
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P2 Study of Postoperative Interferon/Fluorouracil vs Cisplatin/Fluorouracil for Hepatocellular Carcinoma.
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