UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of gemcitabine and nab-paclitaxel followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer
Acronym	A phase II study of gemcitabine and nab-paclitaxel followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer
Scientific Title	A phase II study of gemcitabine and nab-paclitaxel followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer
Scientific Title:Acronym	A phase II study of gemcitabine and nab-paclitaxel followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer
Region	Japan

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

Objectives
Narrative objectives1	To assess the efficacy and safety of gemcitabine and nab-paclitaxel followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival
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	GEM+nab-PTX for 12 weeks or 3cycles: nab-PTX 125mg/m2 day1, 8, 15 every 4 weeks GEM 1000 mg/m2 day1, 8, 15 every 4 weeks S-1+RT: S-1 80/100/120 mg/day based on BSA, day1-14 and 22-35 RT 1.8Gy/day, 28fractions, total 50.4Gy
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)Radiographic diagnosis of pancreatic ductal adenocarcinoma and histologic or cytologic confirmation of adenocarcinoma (2)Unresectable locally advanced pancreatic cancer without distant metastases (3)No evidence of gastroduodenal invasion or obstruction (4)Age: 20-75 (5)ECOG PS: 0 or 1 (6)No prior chemotherapy or radiotherapy (7)Written informed consent (8)Adequate organ function
Key exclusion criteria	(1)Severe concurrent disease (2)Interstitial pneumonia or severe pulmonary emphysema (3)Clinically significant mental disorder (4)Active concomitant malignancy (5)Moderate or severe diarrhea, hemorrhagic colitis or peptic ulcer (6)Infection requiring systemic treatment (7)Fever of 38 degrees centigrade or higher (8)Pregnant or lactating females (9)Under treatment with systemic steroid or immunosuppressive agent (10)Severe drug hypersensitivity (11)Regular use of phenytoin, warfarin or frucitocin (12)Gr2 or more peripheral sensory neuropathy (13)Inappropriate for entry onto the study, as diagnosed by primary physician
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kentaro Sudo
Organization	Chiba Cancer Center
Division name	Gastroenterology
Zip code
Address	Nitona-cho 666-2, Chuo-ku, Chiba, Japan 260-8717
TEL	043-264-5431
Email	ksudo@chiba-cc.jp

Public contact
Name of contact person	1st name Middle name Last name Kentaro Sudo
Organization	Chiba Cancer Center
Division name	Gastroenterology
Zip code
Address	Nitona-cho 666-2, Chuo-ku, Chiba, Japan 260-8717
TEL	043-264-5431
Homepage URL
Email	ksudo@chiba-cc.jp

Sponsor
Institute	Chiba Cancer Center
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 03 Month 13 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	2017 Year 03 Month 08 Day
Date of IRB	2017 Year 03 Month 08 Day
Anticipated trial start date	2017 Year 03 Month 14 Day
Last follow-up date	2021 Year 12 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 03 Month 13 Day
Last modified on	2022 Year 03 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030448