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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012456
Receipt No. R000014580
Scientific Title Preoperative gemcitabine plus nab-paclitaxel, concurrent 3D conformal radiation therapy for borderline resectable pancreatic cancer: Phase I study
Date of disclosure of the study information 2013/12/03
Last modified on 2017/06/14

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Basic information
Public title Preoperative gemcitabine plus nab-paclitaxel, concurrent 3D conformal radiation therapy for borderline resectable pancreatic cancer: Phase I study
Acronym GEM/nabPTX CRT for BR pancreatic cancer
Scientific Title Preoperative gemcitabine plus nab-paclitaxel, concurrent 3D conformal radiation therapy for borderline resectable pancreatic cancer: Phase I study
Scientific Title:Acronym GEM/nabPTX CRT for BR 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 The trial objectives is to identify the maximum-tolerated dose (MTD) of gemcitabine plus nab-paclitaxel and concurrent radiation therapy for borderline resectable pancreatic cancer in the setting of preoperative treatment sequence.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety
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 Induction chemotherapy with GEM/n-P followed by GEM/n-P CRT.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria (1)Patients with BR pancreatic cancer involving 180 degree of less of the circumference of the SMA, CA, or CHA.
(2)Performance Status (ECOG): 0 or 1
(3)Adequate bone marrow reserves, liver/renal functions:
WBC: >=3500/mm3, =<;12000/mm3
Neutrophil: >=1500/mm3
Platelet: >=100000/mm3
Hb: >=9.5g/dL
AST, ALT, AL-P: less than twofold of the upper limit of normal range
T-Bil: =<1.5mg/dL
Cr: =<1.2mg/dL
CCr: >=50ml/min
PaO2: >=70torr
(4)Life expectancy more than 6 months
(5)Written informed consent
Key exclusion criteria (1)evident infection
(2)Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings.
(3)Severe complication(liver cirrhosis, uncontrolled diabetes etc)
(4)the onset of myocardial infarction within 3 months
(5)active synchronous malignancy
(6) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
(7)history of severe drug allergy
(8)neuropathy
(9)patients who are judged inappropriate for the entry of the trial by the investigators
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidenori Takahashi
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Gastroenterological Surgery
Zip code
Address 1-3-3, Nakamichi, Higashinari-ku, Osaka city, Japan
TEL +81-6-6972-1181
Email takahasi-hi@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidenori Takahashi
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Gastroenterological Surgery
Zip code
Address 1-3-3, Nakamichi, Higashinari-ku, Osaka city, Japan
TEL +81-6-6972-1181
Homepage URL
Email takahasi-hi@mc.pref.osaka.jp

Sponsor
Institute Department of Gastroenterological Surgery, Osaka Medical Center for Cancer & Cardiovascular Diseases
Institute
Department

Funding Source
Organization Department of Gastroenterological Surgery, Osaka Medical Center for Cancer & Cardiovascular Diseases
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
2013 Year 12 Month 03 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
2013 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 03 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
2013 Year 12 Month 02 Day
Last modified on
2017 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014580

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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