UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study of hepatic arterial infusion chemotherapy with gemcitabine and 5FU for postoperative liver metastases from pancreatic cancer.
Title of the study (Brief title)	HAI chemotherapy with GEM+5FU
Region	Japan

Condition
Condition	Postoperative liver metastases from pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Treatment for postoperative liver metastases from pancreatic cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	adverse events
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	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	chemotherapy
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Postoperative liver metastases without another recurrent plase.
Key exclusion criteria	Another metastases or not R0 resection case.
Target sample size	12

Research contact person
Name of lead principal investigator	Tetsuo Ohta
Organization	Kanazawa University Hospital
Division name	Hepato-Biliary-Pancreatic Surgery
Address	13-1 Takaramachi, Kanazawa
TEL	076-265-2362
Email	hidetaji@staff.kanazawa-u.ac.jp

Public contact
Name of contact person	Hidehiro Tajima
Organization	Kanazawa University Hospital
Division name	Hepato-Biliary-Pancreatic Surgery
Address	13-1 Takaramachi, Kanazawa
TEL	076-265-2362
Homepage URL
Email	hidetaji@staff.kanazawa-u.ac.jp

Sponsor
Institute	Department of Gastroenterologic Surgery, Kanazawa University
Institute
Department

Funding Source
Organization	Department of Gastroenterological Surgery, Kanazawa University
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 04 Month 01 Day
Anticipated trial start date	2010 Year 05 Month 13 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2016 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 06 Month 28 Day
Last modified on	2016 Year 12 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012942