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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002976
Receipt No. 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

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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)
Email 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
Email contact@keio-hpbts.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.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


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