UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000549 |
|---|---|
| Receipt number | R000000667 |
| Scientific Title | A phase II study to evaluate the effect of adjuvant chemotherapy using hepatic arterial infusion chemotherapy of 5-fluorouracil plus systemic chemotherapy of gemcitabine after resection of pancreatic cancer |
| Date of disclosure of the study information | 2006/12/15 |
| Last modified on | 2012/12/19 20:04:37 |
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Basic information
Public title
A phase II study to evaluate the effect of adjuvant chemotherapy using hepatic arterial infusion chemotherapy of 5-fluorouracil plus systemic chemotherapy of gemcitabine after resection of pancreatic cancer
Acronym
A phase II study to evaluate the effect of adjuvant chemotherapy using hepatic arterial 5FU plus systemic gemcitabine after resection of pancreatic cancer
Scientific Title
A phase II study to evaluate the effect of adjuvant chemotherapy using hepatic arterial infusion chemotherapy of 5-fluorouracil plus systemic chemotherapy of gemcitabine after resection of pancreatic cancer
Scientific Title:Acronym
A phase II study to evaluate the effect of adjuvant chemotherapy using hepatic arterial 5FU plus systemic gemcitabine after resection of pancreatic cancer
Region
| Japan |
Condition
Condition
resectable pancreatic cancer
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the safety and survival benefit of adjuvant chemotherapy using hepatic arterial 5FU plus systemic gemcitabine after resection of pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
disease-free survival time
Key secondary outcomes
adverse effect, treatment compliance, survival time
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
adjuvant chemotherapy using hepatic arterial 5FU (1000mg/m2) plus systemic gemcitabine (1000mg/m2) on days 1, 8, 15 every 28 days x 6 courses
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 proven ductal pancreatic cancer
2) no previous treatment
3) older than 20
4) Karnofsky Performance Status >= 50
5) normally functioning other organs
6) patient informed consent by documentation
Key exclusion criteria
1) interstitial pneumonia, pulmonary fibrosis
2) intractable pleural effusion
3) intractable diabetes mellitus or liver dysfunction
4) distant metastasis
5) other active cancers
6) apparent infection
7) sever postoperative complications
8) active peptic ulcer
9) episode of myocardial infarction within three months
10) mental disorders
11) pregnacy or patient's hope to be pregnant
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Sho |
Organization
Nara Medical University
Division name
Department of Surgery
Zip code
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-29-8863
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nara Medical University
Division name
Department of Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
Organization
Division
Category of Funding Organization
Self funding
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
| 2006 | Year | 12 | Month | 15 | 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
Completed
Date of protocol fixation
| 2006 | Year | 08 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 12 | Month | 13 | Day |
Last modified on
| 2012 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000667
