UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of adjuvant chemotherapy with gemcitabine and regional arterial infusion of nafamostat mesilate for the patients with resectable pancreatic cancer
Acronym	Chemotherapy with gemcitabine and nafamostat mesilate for the patients with resectable pancreatic cancer
Scientific Title	Phase II study of adjuvant chemotherapy with gemcitabine and regional arterial infusion of nafamostat mesilate for the patients with resectable pancreatic cancer
Scientific Title:Acronym	Chemotherapy with gemcitabine and nafamostat mesilate for the patients with resectable pancreatic cancer
Region	Japan

Condition
Condition	Adenocarcinoma of pancreas after curative resection
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of adjuvant chemotherapy with gemcitabine and nafamostat mesilate for the patients with resectable adenocarcinoma of pancreas.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall Survival
Key secondary outcomes	Disease Free survival one-year and three-year survival rate incidence rate of adverse events

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
Interventions/Control_1	Gemcitabine was i.v. administered at a fixed dose of 1000 mg/m2 for 30 min on days 1, 8 and 15, every 4 weeks for six cycles. Nafamostat mesilate is administered via a port-catheter system for 24 h through the common hepatic artery and celiac artery on days 1, 8 and 15, every 4 weeks for six cycles.
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	1)Patients of age =>20 and 80> 2)Patients with gross complete (R0 or R1) resection of adenocarcinoma of pancreas 3)Tolerable to chemotherapy within 8 weeks after surgery 4)Karnofsky performance status =>70% 5)Hemoglobin >=9.0g/dl, WBC>=3,000/mm3,12,000/mm3, Neutrophils >=1,500/mm3, Platelets >=100,000/mm3, AST/ALT </=2.5 x ULN, Total bilirubin </=2.0 x ULN, Serum creatinine </=1.0 x ULN, BUN </=1.0 x ULN, PaO2 >= 70 torr Creatinine clearance>=60 ml/min 6)No replaced common hepatic artery, gastroduodenal artery and celiac artery 7)Written informed consent
Key exclusion criteria	1)Pulmonary fibrosis or interstitial pneumonia detectable on chest X-ray 2)Active infection 3)Uncontrollable heart disease and myocardial infarction within 6 months 4)Uncontrollable DM 5)Pregnant or lactation women, or women with known or suspected pregnancy 6)History of severe drug allergy 7)Active synchronous or metachronous malignancy 8)Severe complications after operation 9)No chemotherapy or radiotherapy for pancreatic cancer in the past 10)Patients who are judged inappropriate for the entry into the study by the investigater
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Katsuhiko Yanaga
Organization	Jikei University school of Medicine
Division name	Department of surgery, Division of hepatobiliary pancreas surgery
Zip code
Address	3-25-8 Nishi-shinbashi, Minato-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Tadashi Uwagawa
Organization	Jikei University school of Medicine
Division name	Department of surgery, Division of hepatobiliary pancreas surgery
Zip code
Address
TEL
Homepage URL
Email	uwatadashi@msn.com

Sponsor
Institute	Jikei University school of Medicine
Institute
Department

Funding Source
Organization	Jikei University school of Medicine Department of surgery Division of hepatobiliary pancreas surgery
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

Other administrative information
Date of disclosure of the study information	2011 Year 08 Month 12 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	2011 Year 07 Month 04 Day
Date of IRB	2011 Year 07 Month 04 Day
Anticipated trial start date	2011 Year 08 Month 01 Day
Last follow-up date	2021 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 08 Month 12 Day
Last modified on	2022 Year 08 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007284