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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026525
Receipt No. R000030448
Scientific Title A phase II study of gemcitabine and nab-paclitaxel followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer
Date of disclosure of the study information 2017/03/13
Last modified on 2017/03/13

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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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 14 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 03 Month 13 Day
Last modified on
2017 Year 03 Month 13 Day


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

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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