UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility and potential benefits of preoperative chemotherapy with Gemcitabine+nab/Paclitaxel in patients with resectable pancreatic cancer: a multicenter phase I/II trial (APCS-01 study).
Title of the study (Brief title)	Multicenter phase I/II study of preoperative chemotherapy with Gemcitabine and nab/Paclitaxel for resectable pancreatic cancer (APCS-01).
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to clarify the safety and efficacy of preoperative chemotherapy with Gemcitabine and nab-Paclitaxel for resectable pancreatic cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	relapse-free survival time
Key secondary outcomes	completion rate of preoperative chemotherapy, over-all survival time, down-staging rate, R0 resection rate, adverse event rate, anti-tumor efficacy

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	Regimen of the chemotherapy: 1000mg/2 of Gemcitabine and 125mg/m2 of nab-Paclitaxel are administered. Schedule: Gemcitabine and nab-Paclitaxel are administered once a week concurrently. A cycle is consisted of three weeks administration and a rest week. Number of chemotherapy cycles is four, and the treatment period is four months.
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Adenocarcinoma and adenosquamous carcinoma is confirmed pathologically. 2. No distant metastases are pointed out. 3. Resectability is diagnosed as "Resectable" according to General Rules for the Study of Pancreatic Cancer, 7th edition. 4. Radical surgery is tolerable. 5. No treatment history of pancreatic cancer. 6. Patient over 20 years old. 7. Good performance status (ECOG PS 0-1). 8. Appropriate biliary drainage has been performed when the patient had obstructive jaundice. 9. Main organ's functions are maintained. 10. Informed consent has been obtained in writing by the patient about the trial participation.
Key exclusion criteria	1. Patient with the treatment history of gemcitabine or nab/paclitaxel. 2. R0 resection is judged to be impossible. 3. Patient with sever diarrhea. 4. Patient with sever ascites and pleural effusion. 5. Patient with active other cancer. 6. Patient with sever coexisting disease. 7. Patients with active infectious disease. 8. Patient with remarkable abnormal electrocardiogram or sever cardiac disorder. 9. Patient with severe psychiatric disorder. 10. Pregnant female, lactating female, female who might be pregnant, female who hopes to be pregnant, and male who hopes the partner's pregnancy. 11. Patient with the history of sever medication allergy. 12. Patient with continuous systemic administration of the steroid. 13. Patient with contraindication of gemcitabine and nab-paclitaxel. 14. Patient where the attending doctor judged unsuitable for safely carrying out.
Target sample size	30

Research contact person
Name of lead principal investigator	Keinosuke Ishido
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Address	5 Zaifu-cho, Hriosaki, Aomori, Japan 036-8562
TEL	0172-39-5079
Email	k-ishido@hirosaki-u.ac.jp

Public contact
Name of contact person	Keinosuke Ishido
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Address	5 Zaifu-cho, Hriosaki, Aomori, Japan 036-8562
TEL	0172-39-5079
Homepage URL
Email	k-ishido@hirosaki-u.ac.jp

Sponsor
Institute	Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization	nothing
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

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 15 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 08 Month 15 Day
Anticipated trial start date	2018 Year 09 Month 15 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	2018 Year 08 Month 26 Day
Last modified on	2018 Year 08 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038663