UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000048 |
|---|---|
| Receipt number | 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 11:43:44 |
* 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
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/
jivrosgoffice@ml.res.ncc.go.jp
Sponsor or person
Institute
Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Institute
Department
Personal name
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
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
Value
https://center6.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 |
