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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028116
Receipt No. R000032118
Scientific Title Phase II study of chemoradiotherapy combined with gemcitabine and nab-paclitaxel for unresectable locally advanced pancreatic cancer
Date of disclosure of the study information 2017/08/01
Last modified on 2018/01/13

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Basic information
Public title Phase II study of chemoradiotherapy combined with gemcitabine and nab-paclitaxel for unresectable locally advanced pancreatic cancer
Acronym NUPAT 05
Scientific Title Phase II study of chemoradiotherapy combined with gemcitabine and nab-paclitaxel for unresectable locally advanced pancreatic cancer
Scientific Title:Acronym NUPAT 05
Region
Japan

Condition
Condition Unresectable locally advanced pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology Hepato-biliary-pancreatic surgery
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of chemoradiotherapy with gemcitabine and nab-paclitaxel for unresectable locally advanced pancreatic cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 2-year survival rates
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Gemcitabine (800mg/m2) and nab-paclitaxel (100mg/ m2) are planed to be administered on Day 1, 8, 15, respectively concurrent with radiotherapy to 50.4 Gy in 28 fractions fore the treatment of unresectable locally advanced pancreatic cancer.
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 who were diagnosed to be pancreatic cancer
2) No distant metastasis
3) Diagnosed unresectable locally advanced pancreatic by rresectability defined by NCCN guideline
4) 20 years of age to 75 years of age
5) ECOG performance status score of 0, 1
6) No prior chemotherapy
7) Primary tumor and adjacent lymph nodes can be treated within 10*10 cm radiation field
8) Enough biliary drainage
9) No invasion to digestive tract
10) No synchronic cancer of other organs
11) Enough oral intake
12) Life expectancy at least 3 months
13) Adequate major organs' function
Key exclusion criteria 1) Distant metastasis
2) Allergy to gemcitabine or nab-paclitaxel
3) Invasion to digestive tract
4) Severe allergy to drags
5) Infection
6) Severe cardiovascular disease
7) Severe basal disease
8) Double cancer
9) Peripheral sensory neuropathy or myelopathy
10) ascites or pleural effusion
11) Active digestive tract bleeding
12) Severe diarrhea
13) Fibroid lung
14) History of radiotherapy for abdomen
15) Uncontrolled cancer pain
16) Lung would be included within radiation field
17) Uncontrolled severe mental disease
18) Pregnant
19) Not obtained consent to this trail
20) Not appropriate for the study at the physician's assessment.

Target sample size 25

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Kodera
Organization Nagoya University Graduate School of Medicine
Division name Gastroenterological Surgery
Zip code
Address 56, Tsurumai-cho, Showa-ku, Nagoya city, Japan
TEL 052-744-2249
Email ykodera@med.nagoya-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Suguru Yamada
Organization Nagoya University Graduate School of Medicine
Division name Gastroenterological Surgery
Zip code
Address 56, Tsurumai-cho, Showa-ku, Nagoya city, Japan
TEL (81)52-744-2249
Homepage URL
Email suguru@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Pancreatic Tumor Bord
Institute
Department

Funding Source
Organization none
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 08 Month 01 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 07 Month 02 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 20 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 07 Month 06 Day
Last modified on
2018 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032118

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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