UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002976 |
|---|---|
| Receipt number | R000003611 |
| Scientific Title | Effects of 5-FU and heparin-based portal infusion chemotherapy combined with MMC and CDDP after curative resection of pancreatic cancer. |
| Date of disclosure of the study information | 2010/01/20 |
| Last modified on | 2017/10/15 22:32:15 |
* 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
Effects of 5-FU and heparin-based portal infusion chemotherapy combined with MMC and CDDP after curative resection of pancreatic cancer.
Acronym
5-FU and heparin-based portal infusion chemotherapy after the resection of pancreatic cancer
Scientific Title
Effects of 5-FU and heparin-based portal infusion chemotherapy combined with MMC and CDDP after curative resection of pancreatic cancer.
Scientific Title:Acronym
5-FU and heparin-based portal infusion chemotherapy after the resection of pancreatic cancer
Region
| Japan |
Condition
Condition
patients after the resection of pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of 5-FU and heparin-based portal infusion chemotherapy as the adjuvant therapy of pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival
Key secondary outcomes
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
with the portal infusion chemotherapy after the resection of pancreatic cancer
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cases with the curative resection of pancreatic cancer
Key exclusion criteria
inoperable cases
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Kitago |
Organization
Department of Surgery, Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
Shinanomachi 35, Shinnjuku-ku, Tokyo 160-8582
TEL
03-3353-1211(ext62529)
contact@keio-hpbts.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minoru Kitago |
Organization
Department of Surgery, Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
Shinanomachi 35, Shinnjuku-ku, Tokyo 160-8582
TEL
03-3353-1211(ext62529)
Homepage URL
contact@keio-hpbts.jp
Sponsor or person
Institute
Keio University School of Medicine
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
慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2001 | Year | 07 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2001 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 05 | Day |
Last modified on
| 2017 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003611
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
