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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003629
Receipt No. R000004401
Scientific Title Phase II study of surgical resection following neoadjuvant chemoradiation using Gemcitibine and TS-1 in patients with potentially and borderline resectable pancreatic cancer
Date of disclosure of the study information 2010/06/01
Last modified on 2018/11/23

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Basic information
Public title Phase II study of surgical resection following neoadjuvant chemoradiation using Gemcitibine and TS-1 in patients with potentially and borderline resectable pancreatic cancer
Acronym Phase II study of surgical resection following neoadjuvant chemoradiation in pancreatic cancer
Scientific Title Phase II study of surgical resection following neoadjuvant chemoradiation using Gemcitibine and TS-1 in patients with potentially and borderline resectable pancreatic cancer
Scientific Title:Acronym Phase II study of surgical resection following neoadjuvant chemoradiation in pancreatic cancer
Region
Japan

Condition
Condition potentially and borderline resectable pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to examine the efficacy and safety
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes frequency of radical resection (R0)
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 Maneuver
Interventions/Control_1 To investigate the frequency of histological curative resection following chemoradiation using Gemcitabine and TS-1in patients with potentially resectable 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
80 years-old >
Gender Male and Female
Key inclusion criteria 1.Patients with Histo-cytologically confirmed pancreatic cancer
2.Patients who have not undergone chemo and/or radiotherapy
3.Patients with radiologically defined patentially resectable pancreatic cancer
4.Patients with no metastatic disease confirmed by staging laparoscopy
5.Patients with Performance status of 0/1
6.Patients with sustained organ function
7.Patients with potentially resectable pancreatic cancer by CT following neoadjuvant chemoradiation
8.Patients who received informed consent
Key exclusion criteria 1) Patients with other active cancers
2) Patients with watery diarrhea
3) Intractable pleural and pericardical effusion, or ascites
4) Severe co-morbid diseases
5) Pregnancy or insufficient contraception
6) Past history of severe drug-allergy
7) Active bacterial or viral infection
8) younger than 20 years old or older than 90 years old.
9) No written informed consent of the patients
10) Pregnancy or insufficient contraception
11) HIV infection
12) Doubtful understanding or contractual capacity of the patient
13) Patients seems inadequate for this study by investigator(s)
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sohei SATOI MD
Organization Kansai Medical University Hospital
Division name Department of Surgery
Zip code
Address 2-3-1, Shin-machi, Hirakata, Osaka 573-1191
TEL 072-804-0101
Email

Public contact
Name of contact person
1st name
Middle name
Last name Sohei SATOI MD
Organization Kansai Medical University Hospita
Division name Department of Surgery
Zip code
Address
TEL
Homepage URL
Email satoi@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University Hospital
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
2010 Year 06 Month 01 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 Terminated
Date of protocol fixation
2010 Year 05 Month 18 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 05 Month 18 Day
Last modified on
2018 Year 11 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004401

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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