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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027758
Receipt No. R000031808
Scientific Title Preoperative gemcitabine plus nab-paclitaxel, concurrent 3D conformal radiation therapy for resectable and borderline resectable pancreatic cancer: Phase II study
Date of disclosure of the study information 2017/06/14
Last modified on 2019/06/16

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Basic information
Public title Preoperative gemcitabine plus nab-paclitaxel, concurrent 3D conformal radiation therapy for resectable and borderline resectable pancreatic cancer: Phase II study
Acronym GEM/nabPTX CRT for advanced pancreatic cancer
Scientific Title Preoperative gemcitabine plus nab-paclitaxel, concurrent 3D conformal radiation therapy for resectable and borderline resectable pancreatic cancer: Phase II study
Scientific Title:Acronym GEM/nabPTX CRT for advanced pancreatic cancer
Region
Japan

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

Objectives
Narrative objectives1 The objective of this trial is to evaluate the treatment efficacy and safety of gemcitabine plus nab-paclitaxel and concurrent radiation therapy for resectable and borderline resectable pancreatic cancer as a preoperative treatment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Overall survival
Key secondary outcomes Disease free survival, Response (either radiological or pathological), R0 resection rate, safety, pattern of recurrence

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/nPTX followed by GEM/nPTX CRT as a preoperative treatment for 3 months.
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 resectable and borderline resecable pancreatic cancer (JPS-T3/4)
(2) PS(ECOG):0 or 1
(3) Adequate bone marrow reserves, liver/renal function:
WBC:>=3,500/mm3, <=12,000/mm3
Neutrophil: >=1,500/mm3
platelet: >=100,000/mm3
Hb: >=9.5g/dL
GOT,GPT,ALP: less than 2.5-fold of the upper limit of normal range
TBil: <=1.5mg/dL
Cr: <=1.2ng/dL
Ccr: >=50ml/min
(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 50

Research contact person
Name of lead principal investigator
1st name Hidenori
Middle name
Last name Takahashi
Organization Osaka International Cancer Institute
Division name Gastroenterological Surgery
Zip code 541-8567
Address 3-1-69, Ohtemae, Chuo-ku, Osaka City, Japan
TEL 0669451181
Email takahasi-hi@mc.pref.osaka.jp

Public contact
Name of contact person
1st name Hidenori
Middle name
Last name Takahashi
Organization Dept. Surgery, Osaka International Cancer Institute
Division name Gastroenterological Surgery
Zip code 541-8567
Address 3-1-69, Ohtemae, Chuo-ku, Osaka City, Japan
TEL 0669451181
Homepage URL
Email takahasi-hi@mc.pref.osaka.jp

Sponsor
Institute Department of Gastroenterological Surgery, Osaka International Cancer Institute
Institute
Department

Funding Source
Organization Osaka International Cancer Institute
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 Osaka International Cancer Institute
Address 3-1-69, Otemae, Chuo-ku, Osaka City
Tel 06-6945-1181
Email matsumotochi@opho.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 大阪国際がんセンター(大阪府)

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 14 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 Enrolling by invitation
Date of protocol fixation
2017 Year 03 Month 31 Day
Date of IRB
2017 Year 03 Month 31 Day
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
2022 Year 05 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
2017 Year 06 Month 14 Day
Last modified on
2019 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031808

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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