UMIN-CTR Clinical Trial

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
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
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	2017 Year 12 Month 04 Day
Anticipated trial start date	2017 Year 12 Month 04 Day
Last follow-up date	2021 Year 12 Month 04 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 07 Month 06 Day
Last modified on	2019 Year 08 Month 14 Day

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