UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study of chemoradiotherapy using gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic cancer
Title of the study (Brief title)	Phase I study of chemoradiotherapy using gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic cancer
Region	Japan

Condition
Condition	unresectable locally advanced pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm the safety of chemoradiotherapy using gemcitabine plus nab-paclitaxel and to determine the Recommended Dose for unresectable locally advanced pancreatic cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	incidence of dose limiting toxicity (within 2 courses)
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	(1)Concurrent radiotherapy is delivered in 28 fractions (a total dose of 50.4Gy). (2)Gemcitabine+Nab-Paclitaxel is intravenously administered on day 1,8 and 15 every 4 weeks.
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)pancreatic cancer (2)no distant metastasis (3)unresectable defined by NCCN guideline (4)age 20-75 (5)Performance Status:0-1(ECOG) (6)initial treatment (7)Radiotherapist determines that all of the primary tumor and lymph node metastasis is possible to be included in the radiation field of 10cm X 10cm (8)biliary drainage for obstructive jaundice (9)no invasion of digestive tract (10)no other organ cancer (11)adequate oral intake (12)Life expectancy more than 3 months (13)adequate organ function (bone marrow, liver, kidney etc) (14)written informed consent
Key exclusion criteria	(1)other distant metastasis (2)allergy of gemcitabine or nab-paclitaxel (3)invasion of digestive tract (4)severe drug allergy (5)active infection (6)severe heart disease (7)severe complications(bowel obstruction, lung fibrosis, interstitial pneumonia, diabetes, renal failure, liver cirrhosis) (8)active synchronous cancer (9)peripheral neuropathy (10)uncontrollable ascites or pleural effusion (11)active gastrointestinal bleeding (12)severe diarrhea (13)mental disorder (14)pregnancy (15)no informed consent (16)inappropriate case (17)pulmonary fibrosis, interstitial pneumonia (18)history of abdominal irradiation (19)uncontrollable carcinomatous pain (20)Lung in the pulmonary field
Target sample size	24

Research contact person
Name of lead principal investigator	Yasuhiro Kodera
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery (Surgery II)
Address	65,Tsurumai-cho,Showa-ku,Nagoya,Aichi,Tsurumai-cho,Showa-ku,Nagoya,Aichi
TEL	052-744-2245
Email	fjt@med.nagoya-u.ac.jp

Public contact
Name of contact person	Tsutomu Fujii
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery (Surgery II)
Address	65,Tsurumai-cho,Showa-ku,Nagoya,Aichi,Tsurumai-cho,Showa-ku,Nagoya,Aichi
TEL	052-744-2245
Homepage URL
Email	fjt@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	名古屋大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 07 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 01 Month 07 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 01 Month 07 Day
Last modified on	2018 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023458