UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010431 |
|---|---|
| Receipt number | R000012198 |
| Scientific Title | Phase I study of transarterial chemoembolization using Cisplatin powder and miriplatin in patients with hepatocellular carcinoma |
| Date of disclosure of the study information | 2013/04/10 |
| Last modified on | 2019/03/10 08:37:48 |
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Basic information
Public title
Phase I study of transarterial chemoembolization using Cisplatin powder and miriplatin in patients with hepatocellular carcinoma
Acronym
Phase I study of doubleplatinum TACE for HCC
Scientific Title
Phase I study of transarterial chemoembolization using Cisplatin powder and miriplatin in patients with hepatocellular carcinoma
Scientific Title:Acronym
Phase I study of doubleplatinum TACE for HCC
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of transarterial chemoembolization using Cisplatin powder and miriplatin in patients with hepatocellular carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
anti-tumor effect
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
miriplatin 60mg
cisplatin 50mg
ethyl ester of iodinated poppy-seed oil fatty acid 6ml
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Substantial enhancement during arterial phase followed by a washout with corona-like peripheral enhancement in equilibrium phase by dynamic CT
2)4 weeks from the prior therapy
3)Anticipated survival is less than 3 months
4)Child A or B
5)Adequate baseline organ and marrow function as defined below:
hemoglobin: >=9.5 g/dL
WBC count: >=3,000/mm3
platelet count: >=50,000 mm3
total bilirubin: =<3.0 mg/dL
AST(GOT): =<ULN x 5
ALT(GPT): =<ULN x 5
albumin >=2.5g/dl
serum creatinine: =<1.5 mg/dL
6)ECOG performance status (PS) 0-1
7)Written informed consent
Key exclusion criteria
1)History of hypersensitivity reaction
2)Other severe complications, such as uncontrollable diabetes or heart failure, renal insufficiency, liver failure
3)Active another cancer
4)Pregnant or possibility pregnancy or nursing woman
5) Physician judged improper to entry this trial
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriyuki Nishino |
Organization
Southern TOHOKU General Hospital
Division name
Department of Gastroenterology
Zip code
Address
7-115, Yatsuyamada, Koriyama-shi, 963-8563Fukushima
TEL
024-934-5322
n.nishino1@mt.strins.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Hamada |
Organization
Southern TOHOKU General Hospital
Division name
Department of Gastroenterology
Zip code
Address
7-115, Yatsuyamada, Koriyama-shi, 963-8563Fukushima
TEL
024-934-5322
Homepage URL
koichi.hamada@mt.strins.or.jp
Sponsor or person
Institute
Southern TOHOKU General Hospital
Institute
Department
Personal name
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
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 | 04 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 20 | 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
| 2013 | Year | 04 | Month | 05 | Day |
Last modified on
| 2019 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012198
