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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025416
Receipt No. R000020580
Scientific Title The feasibility phase II trial for multidisciplinary therapy for borderline resectable pancreatic cancer.
Date of disclosure of the study information 2016/12/26
Last modified on 2019/06/28

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Basic information
Public title The feasibility phase II trial for multidisciplinary therapy for borderline resectable pancreatic cancer.
Acronym GEM/nPTX & SURGERY trial
Scientific Title The feasibility phase II trial for multidisciplinary therapy for borderline resectable pancreatic cancer.
Scientific Title:Acronym GEM/nPTX & SURGERY trial
Region
Japan

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

Objectives
Narrative objectives1 To investigate the feasibility and efficacy of neoadjuvant chemotherapy using GEM/nPTX for borderline resectable pancreatic cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes The postoperative morbidity rate of pancreatectomy following neo-adjuvant GEM/nPTx
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Preoperative chemotherapy using GEM/nPTX and panreatectomy
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1)Patients with pancreatic cancer which is too advanced locally to be resected curatively.
2)The fair or more function of major organs is mainteined.
3)Written informed consent is obtained
Key exclusion criteria 1)Distant metastasis
2)Unresectable local invasion
3)Previous chemotherapy performed within 3 months
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Inoue
Middle name
Last name Yosuke
Organization Japanese foundation for cancer research, Cancer institute hospital
Division name The dept of digestive and HBP surgery
Zip code 135-8550
Address 3-8-31, Ariake, Koto-ku, Tokyo
TEL 0335200111
Email sukeyaubj@yahoo.co.jp

Public contact
Name of contact person
1st name Yosuke
Middle name
Last name Inoue
Organization Ganstointestinal Surgery department, The Cancer Institute Hospital
Division name The dept of digestive and HBP surgery
Zip code 135-8550
Address 3-8-31, Ariake, Koto-ku, Tokyo
TEL 0335200111
Homepage URL
Email sukeyaubj@yahoo.co.jp

Sponsor
Institute Japanese foundation for cancer research, Cancer institute hospital
Institute
Department

Funding Source
Organization Japanese foundation for cancer research, Cancer institute hospital
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Japanese foundation for cancer research, Cancer institute hospital
Address 3-8-25, Ariake, Koto-ku, Tokyo
Tel 0335200111
Email sukeyaubj@yahoo.co.jp

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
2016 Year 12 Month 26 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 No longer recruiting
Date of protocol fixation
2016 Year 01 Month 07 Day
Date of IRB
2016 Year 01 Month 07 Day
Anticipated trial start date
2016 Year 01 Month 07 Day
Last follow-up date
2021 Year 12 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
2016 Year 12 Month 26 Day
Last modified on
2019 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020580

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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