UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000048
Receipt No. R000000089
Scientific Title Phase I/II study of hepatic arterial infusion chemotherapy of gemcitabine for unresectable cholangiocarcinoma (JIVROSG-0301)
Date of disclosure of the study information 2005/08/07
Last modified on 2010/11/12

* 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 I/II study of hepatic arterial infusion chemotherapy of gemcitabine for unresectable cholangiocarcinoma (JIVROSG-0301)
Acronym HAI-GEM for cholangiocarcinoma (JIVROSG-0301)
Scientific Title Phase I/II study of hepatic arterial infusion chemotherapy of gemcitabine for unresectable cholangiocarcinoma (JIVROSG-0301)
Scientific Title:Acronym HAI-GEM for cholangiocarcinoma (JIVROSG-0301)
Region
Japan

Condition
Condition Unresectable cholangiocarcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology Hepato-biliary-pancreatic surgery
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the dose limiting toxicity (DLT) and the recommended dose (RD) of gemcitabine on hepatic arterial infusion in patients with unresectable cholangiocarcinoma, and to evaluate safety and tumor response with this therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Adverse reaction
Key secondary outcomes Response rate, response rate for intrahepatic lesions, overall response rate.

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 Maneuver
Interventions/Control_1 Patients receive hepatic arterial infusion of gemcitabine via an indwelling catheter and port system at day 1,8, and 15. Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.
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) Unresectable or survival-limiting intrahepatic cholangiocarcinoma with histologic confirmation.
2) No prior administration of gemcitabine, and no influence of previous treatments.
3) Measurable lesion in the liver according to RECIST.
4) A hepatic arterial catheter and port system placed and the adequate drug distribution confirmed by CT angiography or MR angiography.
5) Age 20 and over.
6) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
7) Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions.
8) Expected survival more than 8 weeks.
9) Written informed consent.
Key exclusion criteria 1) Extensive tumor involvement to hepatic hilum with or without preceding or scheduled radiation therapy.
2) Infectious disease except viral hepatitis with fever over 38 degree Celcius or antibiotics required.
3) Concurrent uncontrolled medical condition.
4) Active other malignancy.
5) Allergic reaction to iodine contrast material.
6) Severe mental disorder.
7) Pregnant or nursing.
8) Hepatic arterial catheter and port system placed by laparotomy.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Inaba
Organization Aichi Cancer Center
Division name Department of Diagnostic Radiology
Zip code
Address 1-1, Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan
TEL 052-762-6111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasuaki Arai
Organization JIVROSG, Coordinating Office
Division name Division of Diagnostic Radiology, National Cancer Center Hospital
Zip code
Address 5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan
TEL 03-3542-2511
Homepage URL http://jivrosg.umin.jp/
Email jivrosgoffice@ml.res.ncc.go.jp

Sponsor
Institute Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2005 Year 08 Month 07 Day

Related information
URL releasing protocol http://jivrosg.umin.jp/
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/20177362
Number of participants that the trial has enrolled
Results
 Of enrolled 16 pts, 6 pats received GEM with 600mg/m2, 6 pts with 800mg /m2 and 4 pts with 1,000mg/m2. DLT was observed in 2 pts at 600mg/m2 and 1 pt at 800mg/m2. All 3 DLTs were due to the delay of second cycle caused by grade 1-2 myelosuppression. No DLT was observed at 1,000mg/m2. Grade 3 or more toxicities were not observed in all cohorts. 
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
2003 Year 10 Month 03 Day
Date of IRB
Anticipated trial start date
2004 Year 05 Month 01 Day
Last follow-up date
2007 Year 06 Month 01 Day
Date of closure to data entry
2007 Year 08 Month 01 Day
Date trial data considered complete
2008 Year 09 Month 01 Day
Date analysis concluded
2009 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 08 Month 07 Day
Last modified on
2010 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000089

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.