UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011285 |
|---|---|
| Receipt number | 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 | 2020/08/04 10:14:26 |
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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
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Yamanaka |
Organization
Mie University School of Medicine
Division name
Radiology
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-231-5029
t-yama@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Yamanaka |
Organization
Mie University School of Medicine
Division name
Radiology
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-231-5029
Homepage URL
t-yama@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Japanese College of Radiology
Institute
Department
Personal name
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
Mie University School of Medicine
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
Tel
059-232-1111
rinri-iin@doc.medic.mie-u.ac.jp
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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 12 | Day |
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
| 2020 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012977
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