UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Survey of treatment strategy and analysis of prognostic factors in borderline resectable pancreatic cancer
Title of the study (Brief title)	Prognostic factors in borderline resectable pancreatic cancer
Region	Japan

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

Objectives
Narrative objectives1	We survey the current status of the treatment strategy for borderline resectable pancreatic cancer in each facility. In addition, we investigate the prognostic factors of borderline resectable pancreatic cancerin a case series study.
Basic objectives2	Others
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	disease-free survival, neoadjuvant theraphy methods, completion rates of neoadjuvant theraphy, RECIST, CA19-9, SUVmax, Pathological effect, R0 resection rate, postoperative complications, postoperative diarrhea rate, readmission rate, completion rates of adjuvant theraphy, the administration period of adjuvant chemotherapy, patterns of recurrence

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	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Borderline resectable pancreatic cancer
Key exclusion criteria	Unsuitable case in this study
Target sample size	700

Research contact person
Name of lead principal investigator	Akihiko Tsuchida
Organization	Tokyo Medical University
Division name	Department of Gastrointestinal and Pediatric Surgery
Address	6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL	03-3342-6111
Email	akihikot@tokyo-med.ac.jp

Public contact
Name of contact person	Yuichi Nagakawa
Organization	Tokyo Medical University
Division name	Department of Gastrointestinal and Pediatric Surgery
Address	6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL	03-3342-6111
Homepage URL	http://gakkai.co.jp/jsps43/index.html
Email	naga@tokyo-med.ac.jp

Sponsor
Institute	Tokyo Medical 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	None (Self-funding)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Participating institutions of Japanese Society of Pancreatic Surgery
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	2016 Year 04 Month 06 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 02 Month 24 Day
Anticipated trial start date	2016 Year 04 Month 06 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	Survay and case series study

Management information
Registered date	2016 Year 04 Month 06 Day
Last modified on	2016 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000025139