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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name