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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025398
Receipt No. R000029075
Scientific Title A phase 2 trial of nab-paclitaxel, oxaliplatin, S1 and itraconazole for unresectable pancreatic cancer
Date of disclosure of the study information 2016/12/27
Last modified on 2016/12/26

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Basic information
Public title A phase 2 trial of nab-paclitaxel, oxaliplatin, S1 and itraconazole for unresectable pancreatic cancer
Acronym Combination chemotherapy with itraconazole for pancreatic cancer
Scientific Title A phase 2 trial of nab-paclitaxel, oxaliplatin, S1 and itraconazole for unresectable pancreatic cancer
Scientific Title:Acronym Combination chemotherapy with itraconazole for pancreatic cancer
Region
Japan

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

Objectives
Narrative objectives1 To assess the efficiency and safety of nab-paclitaxel,oxaliplatin, S-1 and itraconazole for unresectable pancreatic cancer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Response rate, operability
Key secondary outcomes Overall survival, progression free survival, disease conctrol rate, adverse events

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 itraconazole 400 mg po day -2~+3
nabpaclitaxel 125 mg/m2 day 1
gemcitabine 1000 mgm2 day 1
L-OHP 85 mg/m2 day 1

q14d
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
80 years-old >
Gender Male and Female
Key inclusion criteria Stage IV pancreatic cancer
no previous chemotherapy
Key exclusion criteria diarrhea
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Sonoda
Organization Meiwa Hospital
Division name Medical Oncology
Zip code
Address Nishinomiya Agenaruo 4-31
TEL 0798-47-1767
Email tsuba@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Sonoda
Organization Meiwa Hospital
Division name Medical Oncology
Zip code
Address Nishinomiya Agenaruo 4-31
TEL 0798-47-1767
Homepage URL
Email tsuba@hyo-med.ac.jp

Sponsor
Institute Meiwa Hospital
Institute
Department

Funding Source
Organization Meiwa Hospital
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 12 Month 27 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
2016 Year 05 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 01 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
2016 Year 12 Month 26 Day
Last modified on
2016 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029075

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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