UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003987 |
|---|---|
| Receipt number | R000004802 |
| Scientific Title | Study for evaluating efficacy and safety of TACE with miriplatin in the treatment of patients with hepatocellular carcinoma |
| Date of disclosure of the study information | 2010/08/09 |
| Last modified on | 2014/08/04 07:02:51 |
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Basic information
Public title
Study for evaluating efficacy and safety of TACE with miriplatin in the treatment of patients with hepatocellular carcinoma
Acronym
MELT study
Scientific Title
Study for evaluating efficacy and safety of TACE with miriplatin in the treatment of patients with hepatocellular carcinoma
Scientific Title:Acronym
MELT study
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and safety of transarterial chemoembolization (TACE) with miriplatin in the treatment of patients with hepatocellular carcinoma (HCC)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to progression
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
TACE with miriplatin
Interventions/Control_2
TACE with epirubicin
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with histologically or clinically diagnosed HCC
2. Patients with HCC that reveals contrast-enhancement in the arterial phase of dynamic CT scan
3. Patients who do not have indication of surgical resection or local therapy including radiofrequency ablation and percutaneous ethanol injection
4. Patients who have not received previous treatment for HCC, or patients who were treated for HCC more than 3 months ago and do not reveal recurrence in the treated lesions.
5. Patients who do not have invasion to bile ducts, extrahepatic metastasis, or tumor thrombus in the portal or hepatic veins.
6. Patients with Child-Pugh class A or B.
7. Serum bilirubin level < 3 mg/dl
8. Serum creatinine level < 1.5 mg/dl
9. White blood cell count >= 3000/mm3
10. Platelet count >= 50000/mm3
11. Hemoglobin concentration >= 9.5 g/dl
12. Patients with PS score (ECOG) of 2 or less.
Key exclusion criteria
1. Patients who have hypersensitiby to iodine or contrast media.
2. Patients who have severe thyroid or heart diseases.
3. Patients who have uncontrolled malignancies other than HCC.
4. Patients who are pregnant or lactating.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatehiro Kagawa |
Organization
Tokai University School of Medicine
Division name
Department of Internal Medicine, Division of Gastroenterology
Zip code
Address
Shimokasuya 143, Isehara
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokai University School of Medicine
Division name
Department of Internal Medicine, Division of Gastroenterology
Zip code
Address
TEL
Homepage URL
kagawa@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine, Department of Internal Medicine, Division of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Tokai University School of Medicine, Department of Internal Medicine, Division of Gastroenterology
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
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
東海大学医学部付属八王子病院、東海大学医学部付属東京病院、東海大学医学部付属大磯病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | Month | 09 | 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
| 2010 | Year | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | 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 | 08 | Month | 03 | Day |
Last modified on
| 2014 | 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=R000004802
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
