UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000573 |
|---|---|
| Receipt number | R000000698 |
| Scientific Title | Phase I/II study of arterial infusion of 5-fluorouracil combined with systemic gemcitabine for unresectable pancreatic cancer |
| Date of disclosure of the study information | 2007/01/16 |
| Last modified on | 2010/07/13 22:58:08 |
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Basic information
Public title
Phase I/II study of arterial infusion of 5-fluorouracil combined with systemic gemcitabine for unresectable pancreatic cancer
Acronym
HAI-5-FU combined with GEM for unresectable pancreatic cancer
Scientific Title
Phase I/II study of arterial infusion of 5-fluorouracil combined with systemic gemcitabine for unresectable pancreatic cancer
Scientific Title:Acronym
HAI-5-FU combined with GEM for unresectable pancreatic cancer
Region
| Japan |
Condition
Condition
Unresectable pancreatic cancer
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 arterial infusion of 5-FU combined with GEM in patients with unresectable pancreatic cancer, and to evaluate safety and efficacy with this therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Adverse reaction
Key secondary outcomes
Response rate, progression-free survival and over all surval
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 arterial infusion of 5-FU via an indwelling catheter and port system and systemic GEM 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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)confirmention of pathologicaly proven invasive pancreatic ductal cancer (adenocarcinoma)
2)Unresectable because of locally advanced pancreatic lesion and/or liver metastases
3)Measurable lesion in the live and/or pancreas according to RECIST
4)malignant lesion in other organ
5)no prior treatment except for surgery
6)PS=0-1(Eastern Cooperative Oncology Group (ECOG) performance )
7)adequate hepatic, renal, bone marrow function
Expected survival more than 8 weeks.
WBC count>=3,000/L
ANC >=1500/L
platelet count>=100,000/L
Hb >=9.0mg/dl
T-bil <=3.0mg/dl
AST/ALP <=5times the upper nomal limits
Cre <=1.5mg/dl
8)written informed concent
Key exclusion criteria
1)distant metastaes except of liver and node
2)adequate drug distribution via celiac arterial infusion with alteration of pancreatic blood flow will not be achieved
3)Interstitial pneumonia in chest X-ray
4)active gastro-duodenal ulcer
5)Allergic reaction to iodine contrast material.
6)Infectious disease with fever over 38 degree Celcius or antibiotics required.
7)Pregnant or nursing.
8)Severe drug allergic reaction
9)The other severe complicated disease
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiro Tanaka |
Organization
Nara Medical University
Division name
Dept of radiology
Zip code
Address
840 Shijocho Kashiharashi city , Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Tanaka |
Organization
Nara Medical University
Division name
Dept of radiology
Zip code
Address
840 Shijocho Kashiharashi city , Japan
TEL
0744-29-8900
Homepage URL
rad@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
non
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
| 2007 | Year | 01 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2006 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 01 | Month | 13 | Day |
Last modified on
| 2010 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000698
