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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011285
Receipt No. R000012977
Scientific Title Combination Treatment of Miriplratin-iodized-oil Suspension Iinjection and Radiofrequency Ablation in Hepatocellular Carcinoma
Date of disclosure of the study information 2013/07/26
Last modified on 2017/09/05

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Basic information
Public title Combination Treatment of Miriplratin-iodized-oil Suspension Iinjection and Radiofrequency Ablation in Hepatocellular Carcinoma
Acronym MOSAIC study
Scientific Title Combination Treatment of Miriplratin-iodized-oil Suspension Iinjection and Radiofrequency Ablation in Hepatocellular Carcinoma
Scientific Title:Acronym MOSAIC study
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 prospectively evaluate the safety and outcomes of combination treatment of miriplratin-iodized-oil suspension injection and radiofrequency ablation in hepatocellular carcinoma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes local tumor progression at 2-year
Key secondary outcomes Adverse event, feasability, initial response, change of tumor marker, local tumor progression on tumor basis at 2-year, overall survival, overall survival rate at 2-year, Progression free survival, Progression free survival rate at 2-year

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Patients with hepatocellular carcinoma recieve combination treatment of miriplratin-iodized-oil suspension injection and radiofrequency ablation.
Thirty-two patients with hepatocellular carcinoma will be treated and followed for 2 years. Study period will be 48 months.
Interventions/Control_2
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) Diagnosis of hepatocellular carcinoma is in untreated segment histologically or radiologically established.
2) Hepatocellular carcinomas are 3 or fewer with a maximum diameter of 3cm or smaller, or a single with a maximum diamter of 5cm or smaller.
3) At least 4 weeks interval from previous treatments.
4) Child-Pugh score is 7 or less.
5) There is no invasion of portal vein, hepatic vein, or bile duct.
6) Liver tumors are not adjacent to the common bile duct or main portal vein.
7) No bile duct abnormality.
8) There is no distant metastasis.
9) Patients are not surgical candidates or they decline surgical intervention.
10) Function of main organs are well preserved.
11) Age of 20 years or older.
12) Performance status is 0 or 1
13) Prognosis is expected 6 months or more
14) Infromed consent is given from the patient.
Key exclusion criteria 1) Artrial-portal or -venous shunting.
2) Hepatic arterial obstruction that may prevent embolization.
3) History of billiary surgery.
4) Tumors are close to the bowel and it is difficult to separate them.
5) Herat failure, Renal failure, and active infection, GI bleeding, double cancers, mental disease.
6) Fever (>38 degree celcius).
7) Allergy to contrast medium, miriplatin or iodized-oil.
8) Pregnant woman or woman who is willing to be pregnant.
9) Other reasons that a primary doctor judges judges as inappropriate for a candidate of this study.
Target sample size 32

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takashi Yamanaka
Organization Mie University School of Medicine
Division name Radiology
Zip code
Address 2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL 059-231-5029
Email t-yama@clin.medic.mie-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takashi Yamanaka
Organization Mie University School of Medicine
Division name Radiology
Zip code
Address 2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL 059-231-5029
Homepage URL
Email t-yama@clin.medic.mie-u.ac.jp

Sponsor
Institute Japanese College of Radiology
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Sumitomo Dainippon Pharma Co., Ltd
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 07 Month 26 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 No longer recruiting
Date of protocol fixation
2013 Year 06 Month 14 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 26 Day
Last follow-up date
2016 Year 08 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 07 Month 26 Day
Last modified on
2017 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012977

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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