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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028101
Receipt No. R000032172
Scientific Title Multicenter phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy for patients with resectable pancreatic cancer.
Date of disclosure of the study information 2017/08/15
Last modified on 2017/07/06

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Basic information
Public title Multicenter phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy for patients with resectable pancreatic cancer.
Acronym Multicenter phase II study of neoadjuvant GEM+nab-PTX for resectable pancreatic cancer.
Scientific Title Multicenter phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy for patients with resectable pancreatic cancer.
Scientific Title:Acronym Multicenter phase II study of neoadjuvant GEM+nab-PTX for resectable pancreatic cancer.
Region
Japan

Condition
Condition Invasive ductal adenocarcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of gemcitabine+nab-paclitaxel therapy as neoadjuvant chemotharpy for resectable pancreatic cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 2 year progression-free survival rate (the initial date in reckoning is set at the date of registration)
Key secondary outcomes Overall survival from registration
Radiological response rate
R0 resection rate
Histological response rate
Protocol compliance
Relative dose intensity
Incidence of 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 gemcitabine and nab-paclitaxel therapy as neoadjuvant therapy
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 1. Resectable pancreatic cancer
2. Adenocarcinoma or adenosquamous carcinoma
3. Age 20-79
4. ECOG PS 0-1
5. Able to eat orally
6. Appropriate biliary drainage if bile duct obstructed
7. No apparent sensory or motor neuropathy
8. No history of chemotherapy within last 3 years
9. No prior therapy for pancreatic cancer 10. Meet all the criteria of laboratory examination
11. Informed consent by patient
Key exclusion criteria 1. History of gemcitabine, nab-paclitaxel
2. Ongoing active other malignancy
3. Allergic to gemcitabine and nab-
4. Computed tomography contrast media allergy
5. poor control of diarrhea
6. Intestinal pneumonia
7. Moderate amount of ascites or pleural effusion
8. Active infection
9. Poor control of diabetes mellitus
10. Serious comorbid conditions
11.Myocardial infarction within last 6 months
12. Systemic steroid therapy
13. Serious psychiatric diseases
14. Planning a baby or pregnancy
15. Planning a baby
16. Judged unable to guarantee safety
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirochika Toyama
Organization Kobe University Graduate School of Medicine
Division name Division of Hepato-biliary-pancreatic Surgery Department of Surgery
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL 078-382-6302
Email tymhr@me.com

Public contact
Name of contact person
1st name
Middle name
Last name Hirochika Toyama
Organization Kobe University Graduate School of Medicine
Division name Division of Hepato-biliary-pancreatic Surgery Department of Surgery
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL 078-382-6302
Homepage URL
Email tymhr@me.com

Sponsor
Institute Division of Hepato-biliary-pancreatic Surgery Department of Surgery, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization Self-funding
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 神戸大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 15 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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 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
2017 Year 07 Month 06 Day
Last modified on
2017 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032172

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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