UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational cohort study of clinically diagnosed unresectable pancreatic cancer patients; A multicenter retrospective, questionnaire analysis in Hokkaido Pancreatic Cancer Study Group (HOPS).
Title of the study (Brief title)	HOPS-UR
Region	Japan

Condition
Condition	Pancreatic adenocarcinoma (PDAC), unresectable (UR)
Classification by specialty	Hepato-biliary-pancreatic medicine Hematology and clinical oncology Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to evaluate outcomes of patients who were clinically diagnosed as UR-PDAC.
Basic objectives2	Others
Basic objectives -Others	To assess the outcomes of patients who were clinically diagnosed as UR-PDAC and were treated in tertiary referral hospitals around Hokkaido prefecture.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Conversion rate to radical surgeries
Key secondary outcomes	Sequential treatment regimens and overall survival (OS)

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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients who were defined as unersectable (UR-) and were ineligible for these two studies by HOPS central MDCT review. 2) Pathologically or cytologically proven diagnosis of pancreas cancer. 3) Patients of age =>20 4) Performance Status:0-1 (ECOG) 5) Adequate oral intake 6) Good main organ function
Key exclusion criteria	Patients who were defined as resectable (R-) or borderline resectable (BR-) by HOPS central MDCT review.
Target sample size	66

Research contact person
Name of lead principal investigator	Yasutoshi Kimura
Organization	Sapporo Medical University
Division name	Department of Surgery, Surgical Oncology and Science
Address	S1 W16, Chuo-ku, Sapporo, Hokkaido 060-8543, Japan
TEL	011-611-2111
Email	kimuray@sapmed.ac.jp

Public contact
Name of contact person	Yasutoshi Kimura
Organization	Sapporo Medical University
Division name	Department of Surgery, Surgical Oncology and Science
Address	S1 W16, Chuo-ku, Sapporo, Hokkaido 060-8543, Japan
TEL	011-611-2111
Homepage URL	http://sapmed-surg1.jp/gairai/optout.shtml
Email	kimuray@sapmed.ac.jp

Sponsor
Institute	Department of Surgery, Surgical Oncology and Science, Sapporo Medical University
Institute
Department

Funding Source
Organization	Department of Surgery, Surgical Oncology and Science, Sapporo Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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	2019 Year 01 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 05 Day
Anticipated trial start date	2016 Year 06 Month 13 Day
Last follow-up date	2018 Year 04 Month 28 Day
Date of closure to data entry	2018 Year 05 Month 26 Day
Date trial data considered complete	2018 Year 05 Month 29 Day
Date analysis concluded	2019 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Background information: age, sex, medical history, Non-surgical treatment information: treatment, drug used, treatment period, treatment effect judgment Surgical information: operative method, operation time, amount of bleeding Postoperative information: postoperative complication, postoperative hospital stay Information on postoperative information: presence or absence of postoperative adjuvant chemotherapy (drug, duration) Presence or absence of recurrence (presence or absence of treatment, content, duration), presence / absence of death, cause of death

Management information
Registered date	2019 Year 01 Month 05 Day
Last modified on	2019 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040393