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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007230
Receipt No. R000008515
Scientific Title Retrograde isolated hepatic perfusion:Phase 1 trial
Date of disclosure of the study information 2012/02/06
Last modified on 2016/05/06

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Basic information
Public title Retrograde isolated hepatic perfusion:Phase 1 trial
Acronym Phase 1 trial of R-IHP
Scientific Title Retrograde isolated hepatic perfusion:Phase 1 trial
Scientific Title:Acronym Phase 1 trial of R-IHP
Region
Japan

Condition
Condition malignant liver neoplasm in advanced stage
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Performing Phase 1 study to establish therapeutic range of antineoplastic agents and evaluating the efficacy (antineoplastic effect, relief of symptoms, and overall survival rate) of
Retrograde isolated hepatic perfusion for inoperatable malignant liver neoplasm
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Adverse effect within 4 weeks after the procedure
5-year survival rate
Key secondary outcomes Assessment of the change in tumor burden 4 and 12 weeks after the procedure according to RECIST criteria

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Establish isolated hepatic circulation using balloon catheters.
Perform the procedure twice, more than 4 weeks apart.
Initial dose is cisplatin 35mg/m2 and gemcitabin 300mg/m2 for cholangio carcinoma and cisplatin 35mg/m2 and epirubicin 30mg/m2 for hepatocellular carcinoma.
Dose and resimen of the agents for metastatic liver neoplasm are determined depending on the histological type.
Increase the dose of cisplatin over every 3 cases by 5mg/m2 and establish the maximum treatment dose of each agent.
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

Not applicable
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1 Written informed consent
2 No indication of surgical resection
3 Apparent increase in tumor size documented within 3 months after chemotherapy
4 Performance status of 0-2 based on the Eastern Cooperative Oncology Group(ECOG) score
5 Acceptable renal function (serum creatinine concentration less than 1.2mg/dl)
6 Acceptable bone marrow function (leukocyte count of more than 3,500/mm3, platelet count of more than 50,000/mm3)
7 Total bilirubin is less than 3mg/dl
Key exclusion criteria 1 Contraindication to angiography (due to severe side effect of contrast media)
2 High risk for general anesthesia
3 Advanced heart disease
4 Tumor invasion to Inferior vena cava or Portal vein trunk
5 Vascular anatomy not suitable for catheterization
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoru Murata
Organization Nippon medical school
Division name Department of Radiology
Zip code
Address Sendagi 1-1-5, Bunkyo-ku, Tokyo
TEL 03-3822-2131
Email genji@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoru Murata
Organization Nippon medical school
Division name Department of Radiology
Zip code
Address Sendagi 1-1-5, Bunkyo-ku, Tokyo
TEL 03-3822-2131
Homepage URL
Email genji@nms.ac.jp

Sponsor
Institute Nippon medical school
Institute
Department

Funding Source
Organization Nippon medical school
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

Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 06 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
2012 Year 02 Month 04 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
2016 Year 01 Month 05 Day
Date of closure to data entry
2016 Year 01 Month 05 Day
Date trial data considered complete
2016 Year 01 Month 05 Day
Date analysis concluded
2016 Year 05 Month 06 Day

Other
Other related information

Management information
Registered date
2012 Year 02 Month 06 Day
Last modified on
2016 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008515

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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