UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007230 |
|---|---|
| Receipt number | 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 11:22:59 |
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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
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
genji@nms.ac.jp
Sponsor or person
Institute
Nippon medical school
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008515
