UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000809 |
|---|---|
| Receipt number | R000000948 |
| Scientific Title | Phase II study of hepatic arterial infusion of cisplatin for unresectable intrahepatic cholangiocarcinoma |
| Date of disclosure of the study information | 2007/08/31 |
| Last modified on | 2019/03/05 12:30:58 |
* 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
Phase II study of hepatic arterial infusion of cisplatin for unresectable intrahepatic cholangiocarcinoma
Acronym
ICC-CDDP
Scientific Title
Phase II study of hepatic arterial infusion of cisplatin for unresectable intrahepatic cholangiocarcinoma
Scientific Title:Acronym
ICC-CDDP
Region
| Japan |
Condition
Condition
intrahepatic cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of hepatic arterial infusion of CDDP for intrahepatic cholangiocarcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
adverse events, overall survival, progression free survival
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
CDDP is administered at a dose of 65 mg/m2 into the hepatic artery. The treatment is repeated every 4 to 6 weeks until a maximum of 6 courses, the appearance of unacceptable toxicity, or disease progression.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) histologically confirmed ICC
2) unresectable or recurrent disease
3) ECOG Performance Status 0-1
4) having measurable lesion
5) adequate organ function
6) no prior chemotherapy using platinum compound
7) no prior radiotherapy
8) written informed consent
Key exclusion criteria
1) presence of uncontrollable ascites or pleural effusion
2) cerebral or bone metastasis
3) uncontrollable cardiovascular disease or prior myocardial infarction
4) active infection other than HBV or HCV
5) other malignancy
6) severe psychiatric disorder
7) severe drug allergy
8) pregnant or nursing
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junji Furuse |
Organization
Kyorin University
Division name
medical oncology
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa
TEL
03-3412-1111
jfuruse@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kohei Nakachi |
Organization
Sapporo Medical University
Division name
Gastroenterology
Zip code
Address
Sapporo
TEL
0155-22-6600
Homepage URL
knakachi-gi@umin.org
Sponsor or person
Institute
Division of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
| 2007 | Year | 08 | Month | 31 | 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
| 2007 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 08 | Month | 26 | Day |
Last modified on
| 2019 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000948
