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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001450
Receipt No. R000001672
Scientific Title Phase II trial of neoadjuvant combination chemotherapy with gemcitabine and S-1 for locally advanced pancreatic cancer
Date of disclosure of the study information 2008/10/21
Last modified on 2016/05/13

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Basic information
Public title Phase II trial of neoadjuvant combination chemotherapy with gemcitabine and S-1 for locally advanced pancreatic cancer
Acronym Phase II trial of neoadjuvant chemotherapy with gemcitabine and S-1 for locally advanced pancreatic cancer
Scientific Title Phase II trial of neoadjuvant combination chemotherapy with gemcitabine and S-1 for locally advanced pancreatic cancer
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Yoshiya Kawaguchi
Organization Faculty of Medicine, Kyoto University
Division name Surgery
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo, Kyoto
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyoto University
Division name Surgery
Zip code
Address
TEL
Homepage URL
Email tmasui@kuhp.kyoto-u.ac.jp

Sponsor
Institute Faculty of Medicine, Kyoto University
Institute
Department

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)

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
2008 Year 10 Month 21 Day

Related information
URL releasing protocol
Publication of results 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 Completed
Date of protocol fixation
2008 Year 09 Month 08 Day
Date of IRB
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

Other
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

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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