UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study of neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel for patients with borderline resectable pancreatic cancer
Title of the study (Brief title)	NAC-GEMABR
Region	Japan

Condition
Condition	Invasive ductal carcinoma
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safetyand efficacyof NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	Adverse event
Key secondary outcomes	1. R0 resection rate 2. Resection rate 3. Optimal duration before surgery to perform neoadjuvant chemotherapy 4. QOL evaluation about peripheral neuropathy using FACT-NTX(Version4)

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	neoadjuvant chemotherapy 2 courses of NAC-GEMABR 1. nab-paclitaxel(Day1,8,15)125mg/m2 30min administration 2. Gemcitabine(Day1,8,15)1000mg/m2 30min administration
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. Pathologically proven invasive pancreatic ductal carcinoma 2. Cases that meet the definition of borderline resectable pancreatic cancer 1) or 2) 1) Definition of a borderline resectable pancreatic cancer is filled in NCCN guideline version 1.2014 pancreatic adenocarcinoma 2) Patients indicated distal pancreatectomy with en bloc celiac axis resection 3. PS (ECOG) 0-1 4. >=20 years old and < 80 years old 5. First line treatment 6. The following criteria must be satisfied in laboratory tests within 14 days of registration White blood cell count <=12,000/mm3 Neutrophil count >=1,500/mm3 Platelet count >=100,000mm3 Total bilirubin <2.0mg/dL Serum Creatinine <=upper limits of normal(ULN) AST, ALT<=2.5xULN Albumin>=3.0g/dL Hemoglobin>=9.0g/dL 7. Written informed consent to participate in this study
Key exclusion criteria	1. Severe drug hypersensitivity 2. Multiple primary cancers within 5 years 3. Severe infection 4. With grade2 or more severe peripheral neuropathy 5. With intestinal paralysys, ileus 6. Interstitial pneumonia or pulmonary 7. With uncontrollable pleural effusion or ascites 8. Receiving atazanavir sulfate 9. With uncontrollable diabetes 10.With uncontrollable heart failure, angina, hypertension, arrhythmia 11.With severe psychological symptoms 12.With watery diarrhea 13.Pregnant or lactating women, or women with known or suspected pregnancy 14.Inappropriate patients for entry on this study in the judgment of the investigator
Target sample size	10

Research contact person
Name of lead principal investigator	Hiroki Yamaue
Organization	wakayama Medical University
Division name	Second Department of Surgery
Address	811-1, Kimiidera, Wakayama
TEL	073-447-2300
Email	yamaue-h@wakayama-med.ac.jp

Public contact
Name of contact person	Ken-ichi Okada
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1, Kimiidera, Wakayama
TEL	073-441-0613
Homepage URL
Email	okada@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
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)

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	和歌山県立医科大学附属病院

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 20 Day
Anticipated trial start date	2015 Year 07 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 22 Day
Last modified on	2017 Year 07 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021286