UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase II trial of neoadjuvant therapy with GEM/IMRT for potentially resectable pancreatic cancer
Title of the study (Brief title)	Neoadjuvant chemoradiation therapy for potentially resectable pancreatic cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of neoadjuvant chemoradiation therapy using Gemcitabine combined with IMRT for potentially resectable pancreatic cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	overall survival
Key secondary outcomes	disease-free survival, pathological responce rate, incident of adverse event, mortality

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 Maneuver
Interventions/Control_1	To investigate the overall survival rate following chemoradiation using Gemcitabine combined with IMRT for potentially resectable pancreatic cancer
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1.Patients with Histo-cytologically confirmed pancreatic cancer 2.Patients with radiologically defined patentially borderline resectable pancreatic cancer 3.Patients with Performance status of 0/1 4.Patients who have not undergone chemo and/or radiotherapyPatients with no metastatic disease confirmed by staging laparoscopy 5.Patiants who can oral intake 6.Patients with normal ECG findings 7.Patients with sustained organ function 8.Patients who received informed consent
Key exclusion criteria	1) Patients with lung fibrosis or interstitional pneumonia 2) Patients who can not underwent radiation therapy because of past radiation therapy 3) Severe co-morbid diseases 4) Intractable pleural and pericardical effusion, or ascites 5) Patients with other active cancers 6)Pregnancy or insufficient contraception 7) severe mental illness 8) Patients seems inadequate for this study by investigator(s)
Target sample size	60

Research contact person
Name of lead principal investigator	Shinji Uemoto
Organization	Graduate School of Medicine and Faculty of Medicine, Kyoto University
Division name	Hepato-pancreato-biliary Surgery and Transplantation
Address	54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,
TEL	075-751-3242
Email	tmasui@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Toshihiko Masui
Organization	Graduate School of Medicine and Faculty of Medicine KyotoUniversity
Division name	Hepato-pancreato-biliary Surgery and Transplantation
Address	54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,
TEL	075-751-3242
Homepage URL
Email	tmasui@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Hepato-pamcreato-biliary Surgery and Transplantation, Graduate School of Medicine and Faculty of Medicine, Kyoto University
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	京都大学医学部附属病院（京都府）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 07 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 05 Month 07 Day
Anticipated trial start date	2016 Year 06 Month 13 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	2016 Year 05 Month 13 Day
Last modified on	2016 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025696