UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II trial of neoadjuvant combination chemotherapy with gemcitabine and S-1 for locally advanced pancreatic cancer
Title of the study (Brief title)	Phase II trial of neoadjuvant chemotherapy with gemcitabine and S-1 for locally advanced pancreatic cancer
Region	Japan

Condition
Condition	locally advanced pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to assess the pathologically margin negative status after GS therapy in patients with locally advanced, unresectable pancreatic cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	pathologically margin negative status
Key secondary outcomes	response rate, toxicity, progression free survival, overall survival

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	S1: bid d1-15 q3w x 3 courses 60mg/sq PO GEM: d1 and d1, q3w x 3 courses 1000mg/sq DIV
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Histologically proven pancreatic adenocarcinoma 2)UICC stageIII with one of the criteria below; a)tumor abutment of the SMA involving half of the artery circumference b)encasement of a short segment of HA without tumor extension to the celiac axis 3)No prior chemotherapy or radiotherapy 4)Age above 20 5)ECOG performance status of 0 or 1 6)Adequate hematologic, hepatic and renal function 7)Written informed consent
Key exclusion criteria	1)Watery diarrhea 2)Severe mental disorder 3)Active infection 4)Severe complications, such as ileus, heart failure and renal failure 5)Symptomatic pulmonary fibrosis or interstitial pneumonia 6)History of radiation therapy to the chest 7)Marked pleural or peritoneal effusion 8)Active concomitant malignancy 9)Treatment with phenytoin, potassium warfarin or flucytosine
Target sample size	35

Research contact person
Name of lead principal investigator	Yoshiya Kawaguchi
Organization	Faculty of Medicine, Kyoto University
Division name	Surgery
Address	54 Kawaharacho, Shogoin, Sakyo, Kyoto
TEL
Email

Public contact
Name of contact person
Organization	Kyoto University
Division name	Surgery
Address
TEL
Homepage URL
Email	tmasui@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Faculty of Medicine, Kyoto University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
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

Other administrative information
Date of disclosure of the study information	2008 Year 10 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 09 Month 08 Day
Anticipated trial start date	2008 Year 12 Month 01 Day
Last follow-up date	2012 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2008 Year 10 Month 21 Day
Last modified on	2016 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001672