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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025675
Receipt No. R000029539
Scientific Title Observational study of neoadjuvant GS chemotherapy for patients with pancreatic cancer
Date of disclosure of the study information 2017/01/14
Last modified on 2017/01/14

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Basic information
Public title Observational study of neoadjuvant GS chemotherapy for patients with pancreatic cancer
Acronym Neoadjuvant GS chemotherapy for pancreatic cancer
Scientific Title Observational study of neoadjuvant GS chemotherapy for patients with pancreatic cancer
Scientific Title:Acronym Neoadjuvant GS chemotherapy for pancreatic cancer
Region
Japan

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

Objectives
Narrative objectives1 Assesment of safety and efficacy of neoadjuvant chemotherapy using gemcitabine and S1 for patients with oancreatic cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Safety and efficacy of the neoadjuvant GS chemotherapy
Key secondary outcomes Changes in tumour size and tumour markers, resection rate and R0 resection rate

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
Interventions/Control_1 Two cycles of neoadjuvant chemotherapy using Gemcitabine(100mg/m2,day1,day8) and S1(100mg/body or 120mg/body, day1-day14)
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)clinical diagnosis of pancreatic cancer
2)no distant metastasis
3)possible macroscopic curative resection
4)treatment naive
5)presence of measurable lesion
6)possible oral intake of S1
7)possible written informed consent
8)age not less than 20
Key exclusion criteria 1)patients with lung fibrosis and/or interstitial pneumoniae
2)unresectable SMA invasion
3)active double cancer
4)active infectious disease
5)creatinine clearance < 30mL/min
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiichi Kubota
Organization Dokkyo Medical University Hospital
Division name Second department of surgery
Zip code
Address Kitakobayashi 880, Mibu, Tochigi, Japan
TEL 0282861111
Email kubotak@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taku Aoki
Organization Dokkyo Medical University Hospital
Division name Second department of surgery
Zip code
Address Kitakobayashi 880, Mibu, Tochigi, Japan
TEL 0282861111
Homepage URL
Email aoki-2su@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

Funding Source
Organization Dokkyo Medical University
Organization
Division
Category of Funding Organization Other
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
2017 Year 01 Month 14 Day

Related information
URL releasing protocol
Publication of results Partially 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 Enrolling by invitation
Date of protocol fixation
2014 Year 02 Month 04 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 04 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
2017 Year 01 Month 14 Day
Last modified on
2017 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029539

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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