UMIN-CTR Clinical Trial

Basic information
Public title	The feasibility phase II trial for multidisciplinary therapy for borderline resectable pancreatic cancer.
Acronym	GEM/nPTX & SURGERY trial
Scientific Title	The feasibility phase II trial for multidisciplinary therapy for borderline resectable pancreatic cancer.
Scientific Title:Acronym	GEM/nPTX & SURGERY trial
Region	Japan

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

Objectives
Narrative objectives1	To investigate the feasibility and efficacy of neoadjuvant chemotherapy using GEM/nPTX for borderline resectable pancreatic cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	The postoperative morbidity rate of pancreatectomy following neo-adjuvant GEM/nPTx
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	Preoperative chemotherapy using GEM/nPTX and panreatectomy
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)Patients with pancreatic cancer which is too advanced locally to be resected curatively. 2)The fair or more function of major organs is mainteined. 3)Written informed consent is obtained
Key exclusion criteria	1)Distant metastasis 2)Unresectable local invasion 3)Previous chemotherapy performed within 3 months
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Inoue Middle name Last name Yosuke
Organization	Japanese foundation for cancer research, Cancer institute hospital
Division name	The dept of digestive and HBP surgery
Zip code	135-8550
Address	3-8-31, Ariake, Koto-ku, Tokyo
TEL	0335200111
Email	sukeyaubj@yahoo.co.jp

Public contact
Name of contact person	1st name Yosuke Middle name Last name Inoue
Organization	Ganstointestinal Surgery department, The Cancer Institute Hospital
Division name	The dept of digestive and HBP surgery
Zip code	135-8550
Address	3-8-31, Ariake, Koto-ku, Tokyo
TEL	0335200111
Homepage URL
Email	sukeyaubj@yahoo.co.jp

Sponsor
Institute	Japanese foundation for cancer research, Cancer institute hospital
Institute
Department

Funding Source
Organization	Japanese foundation for cancer research, Cancer institute hospital
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Japanese foundation for cancer research, Cancer institute hospital
Address	3-8-25, Ariake, Koto-ku, Tokyo
Tel	0335200111
Email	sukeyaubj@yahoo.co.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	2016 Year 12 Month 26 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	No longer recruiting
Date of protocol fixation	2016 Year 01 Month 07 Day
Date of IRB	2016 Year 01 Month 07 Day
Anticipated trial start date	2016 Year 01 Month 07 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 12 Month 26 Day
Last modified on	2019 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020580