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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011062
Receipt No. R000012944
Scientific Title Phase I study of neoadjuvant chemotherapy with gemcitabine and nab paclitaxel for resectable pancreatic cancer.
Date of disclosure of the study information 2013/07/01
Last modified on 2019/07/03

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Basic information
Public title Phase I study of neoadjuvant chemotherapy with gemcitabine and nab paclitaxel for resectable pancreatic cancer.
Acronym NAC with GEM+nab-PTX for pancreatic cancer
Scientific Title Phase I study of neoadjuvant chemotherapy with gemcitabine and nab paclitaxel for resectable pancreatic cancer.
Scientific Title:Acronym NAC with GEM+nab-PTX for pancreatic cancer
Region
Japan

Condition
Condition resectable pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Optimal dose of GEM + nab-PTX combination therapy as preoperative chemotherapy for pancreatic cancer surgery patients and I see all the properties.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We can evaluate the sensitivity of anti-cancer drugs at a time when evaluable lesions prior to surgery. Prolongation of disease free survival and 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 dose escalation of nab-PTX
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 resectble pancreatic cancer patients withour serious complications
Key exclusion criteria 1) Patients with anti-cancer agent administration in history past
2) Active another cancer
3) Severe complications
4) Patients with interstitial pneumonia or pulmonary fibrosis
5) Active infection
6) Pregnant woman
7) Severe mental disorder
8) Others
Target sample size 18

Research contact person
Name of lead principal investigator
1st name Hidehiro
Middle name
Last name Tajima
Organization Kanazawa University Hospital
Division name Hepato-Biliary-Pancreatic Surgery
Zip code 920-8641
Address 13-1 Takaramachi, Kanazawa
TEL 076-265-2362
Email hidetaji@staff.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name Hidehiro
Middle name
Last name Tajima
Organization Kanazawa University Hospital
Division name Hepato-Biliary-Pancreatic Surgery
Zip code 920-8641
Address 13-1 Takaramachi Kanazawa
TEL 076-265-2362
Homepage URL
Email crc.irb-knz@esct.jp

Sponsor
Institute Department of Gastroenterological Surgery, Kanazawa University
Institute
Department

Funding Source
Organization None.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization JP

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

IRB Contact (For public release)
Organization Department of Gastroenterological Surgery, Kanazawa University
Address 13-1 Takaramachi
Tel +81762362
Email hidetaji@staff.kanazawa-u.ac.jp

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
2013 Year 07 Month 01 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
2013 Year 05 Month 20 Day
Date of IRB
2013 Year 06 Month 01 Day
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 28 Day
Last modified on
2019 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012944

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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