UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy for patients with resectable pancreatic cancer.
Title of the study (Brief title)	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	Hirochika Toyama
Organization	Kobe University Graduate School of Medicine
Division name	Division of Hepato-biliary-pancreatic Surgery Department of Surgery
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	Hirochika Toyama
Organization	Kobe University Graduate School of Medicine
Division name	Division of Hepato-biliary-pancreatic Surgery Department of Surgery
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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