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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004526
Receipt No. R000005404
Scientific Title Transcatheter arterial infusion chemotherapy using miriplatin in patients with advanced hepatocellular carcinoma: Prospective randomized study, Lip-TAI vs. Lip+DSM-TAI
Date of disclosure of the study information 2010/11/10
Last modified on 2017/05/16

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Basic information
Public title Transcatheter arterial infusion chemotherapy using miriplatin in patients with advanced hepatocellular carcinoma: Prospective randomized study, Lip-TAI vs. Lip+DSM-TAI
Acronym TAI using miriplatin: Lip-TAI vs. Lip+DSM-TAI
Scientific Title Transcatheter arterial infusion chemotherapy using miriplatin in patients with advanced hepatocellular carcinoma: Prospective randomized study, Lip-TAI vs. Lip+DSM-TAI
Scientific Title:Acronym TAI using miriplatin: Lip-TAI vs. Lip+DSM-TAI
Region
Japan

Condition
Condition hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We investigate the efficacy of lipiodol+degradable starch microspheres (DSM)-transarterial infusion chemotherapy (TAI) using miriplatin for advanced HCC in a randomized trial between lipiodol-TAI and lipiodol+DSM-TAI.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time-to-progression
Key secondary outcomes Tumor response, overall survival, and safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Lipiodol-TAI using miriplatin
The injection of Lipiodol was limited to 6 mL.
Interventions/Control_2 Lipiodol+DSM-TAI
After the administration of emulsion using miriplatin and Lipiodol, DSM was injected. The injection of Lipiodol was limited to 6 mL.
Interventions/Control_3 Lipiodol-TAI using miriplatin
The injection of Lipiodol was limited to 10 mL.
Interventions/Control_4 Lipiodol+DSM-TAI
After the administration of emulsion using miriplatin and Lipiodol, DSM was injected. The injection of Lipiodol was limited to 10 mL.
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) Histologically proven or clinically diagnosed hepatocellular carcinoma.
2) Locally nodular disease without extrahepatic metastasis.
3) No indication for surgical resection and local ablation.
4) No vascular tumor thrombosis (portal vein, hepatic vein, and bile duct).
5) Not remarkable findings of A-V shunt and/or A-P shunt.
6) The emulsion of miriplatin and Lipiodol<= 6 mL: The maximum tumor diameter <= 5 cm and the tumor number <= 5 nodules in the liver.
The emulusion of miriplatin and lipiodol > 6 mL: The maxmum tumor diameter <= 10 cm and the tumor number <= 10 nodules in the liver.
7) Do not have effect of pervious treatment.
8) Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
9) Child-Pugh score of A or B.
10) Adequate organ and marrow function listed below.
(1) leukocyte count >= 3000/mm3
(2) platelet count >= 50000/mm3
(3) hemoglobin level >= 9.5 g/dL
(4) total bilirubin <= 3.0 mg/dL
(5) serum albumin 2.5-3.5 g/dL
(6) serum creatinine level normal upper level
(7) BUN <= 25 mg/dL
11) Age >= 20 years old
12) Life expectancy at least 3 months.

Key exclusion criteria 1) Parients with severe complicating disease except chronic hepatitis or liver cirrhosis.
2) Patients with active double cancer.
3) The patient with the anamnesis of the hypersensitivity.
4) A pregnant woman, or woman who may pregnant and who are nursing.
5) Patients who were disqualified by doctor in attendance.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Yamasaki
Organization Yamaguchi Univercity Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 1-1-1 Minamikogushi, Ube, Yamaguchi
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Yamaguchi Univercity Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 1-1-1 Minamikogushi, Ube, Yamaguchi
TEL
Homepage URL
Email

Sponsor
Institute Department of Gastroenterology and Hepatology, Yamaguchi Univercity Graduate School of Medicine
Institute
Department

Funding Source
Organization None
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
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
2010 Year 11 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2010 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 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
2010 Year 11 Month 09 Day
Last modified on
2017 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005404

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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