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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023591
Receipt No. R000027167
Scientific Title Feasibility study of neoadjuvant gemcitabine plus nab-paclitaxel for borderline resectable pancreatic cancer
Date of disclosure of the study information 2016/08/10
Last modified on 2019/03/07

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Basic information
Public title Feasibility study of neoadjuvant gemcitabine plus nab-paclitaxel for borderline resectable pancreatic cancer
Acronym Feasibility study of NAC GEM+nab-PTX for BRPC
Scientific Title Feasibility study of neoadjuvant gemcitabine plus nab-paclitaxel for borderline resectable pancreatic cancer
Scientific Title:Acronym Feasibility study of NAC GEM+nab-PTX for BRPC
Region
Japan

Condition
Condition Borderline resectable pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate feasibility of neoadjuvant gemcitabine plus nab-paclitaxel in patients with borderline resectable pancreatic cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Feasibility for 2 cycles of GEM+nab-PTX therapy
Key secondary outcomes R0 resection rate, Response rate, Histological effect, Adverse events, Severe adverse events, Treatment-related death

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 Administration of neoadjuvant GEM+nab-PTX
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) Diagnosed as pancreatic cancer by imaging and histologically proven adenocarcinoma
2) No distant metastasis
3) Borderline resectable pancreatic cancer by NCCN Guidelines Version 2.2015
4) Without ascites/pleural effusion
5) Measurable disease not mandatory
6) Eastern Cooperative Oncology Group performance status 0-1
7) Peripheral neuropathy (Grade0 or 1)
8) No prior therapy for malignancy
9) Adequate organ function
10) Written informed consent
Key exclusion criteria 1) With pulmonary fibrosis or interstitial pneumonia
2) With active double cancers
3) With severe complications such as heart failure, bowel obstruction and uncontrollable diabetes millitus
4) With active infection
5) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant
6) Psychosis or severe mental disorder
7) Recieving systemic steroid therapy
8) With severe drug allergy
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junji Furuse
Organization Kyorin University, School of Medicine
Division name Department of Medical Oncology
Zip code
Address 6-20-2, Shinkawa, Mitaka-shi, Tokyo, 181-8611, Japan
TEL 0422-47-5511
Email jfuruse@ks.kyorin-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naohiro Okano
Organization Kyorin University, School of Medicine
Division name Department of Medical Oncology
Zip code
Address 6-20-2, Shinkawa, Mitaka-shi, Tokyo, 181-8611, Japan
TEL 0422-47-5511
Homepage URL
Email naohiro-okano@ks.kyorin-u.ac.jp

Sponsor
Institute Kyorin University, School of Medicine
Institute
Department

Funding Source
Organization Kyorin University, School of Medicine
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
2016 Year 08 Month 10 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 Completed
Date of protocol fixation
2016 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 24 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
2016 Year 08 Month 10 Day
Last modified on
2019 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027167

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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