UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003987
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email kagawa@is.icc.u-tokai.ac.jp

Sponsor
Institute Tokai University School of Medicine, Department of Internal Medicine, Division of Gastroenterology
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004802

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.