UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of 5-FU and heparin-based portal infusion chemotherapy combined with MMC and CDDP after curative resection of pancreatic cancer.
Title of the study (Brief title)	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	Minoru Kitago
Organization	Department of Surgery, Keio University School of Medicine
Division name	Department of Surgery
Address	Shinanomachi 35, Shinnjuku-ku, Tokyo 160-8582
TEL	03-3353-1211(ext62529)
Email	contact@keio-hpbts.jp

Public contact
Name of contact person	Minoru Kitago
Organization	Department of Surgery, Keio University School of Medicine
Division name	Department of Surgery
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2001 Year 07 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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