UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Estimating the Effects of Neoadjuvant Chemoradiotherapy for Adenocarcinoma of the Pancreatic Head using Inverse Probability of Treatment Weighting: A Dual-institution Observational Study
Title of the study (Brief title)	NACRT for PDAC
Region	Japan

Condition
Condition	Resectable pancreatic adenocarcinoma, borderline resectable pancreatic adenocarcinoma with portal vein invasion or arterial invasion
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of neoadjuvant chemoradiotherapy (NACRT) in patients with resectable (R) or borderline resectable (BR) adenocarcinoma of the pancreatic head. BR diseases were classified into two groups: lesions involving exclusively the portal vein system (BR-PV) and lesions abutting the major artery (BR-A).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Survival, short-term clinic benefit, the effect of NACRT, adverse events
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Neoadjuvant chemoradiotherapy
Interventions/Control_2	Upfront surgery
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Histologically proven pancreatic adenocarcinoma (2) Age between 20 and 85 years (3) ECOG performance status of 0 or 1 (4)Resectable and Borderline resectable pancreatic cancer (NCCN criteria) (5) Adequate hematologic, renal, hepatic and respiratory function (6) Written informed consent (7)Operation performed in Nagoya University Hospital and Kansai Medical University
Key exclusion criteria	(1) Unresectable pancreatic cancer (NCCN criteria) (2)Tumors with encasement or stenosis of the arteries, those abutted with the celiac axis (3) Hematologic, renal, hepatic and respiratory dysfunction (4)Active infections (5) Severe cardiac disorder, renal disorder, liver disorder, ulcer with bleeding, intestinal tract paralysis, uncontrollable diabetes mellitus (6) Presence of pleural effusion or ascites requiring drainage (7)Pregnant females or nursing mothers who can not stop lactation. Patients or partners, who don't attempt to doing contraception during the study period. (8) Severe mental disorder (9) Severe drug hypersensitivity (10) As determined by the principal investigator or the sub-investigator the subject is not adequate to participate in the trial.
Target sample size	504

Research contact person
Name of lead principal investigator	Yasuhiro Kodera
Organization	Nagoya University Graduate School of Medicine
Division name	Gastroenterological Surgery (Surgery II)
Address	65,Tsurumai-cho,Showa-ku,Nagoya,Aichi, Japan
TEL	052-744-2245
Email	fjt@med.nagoya-u.ac.jp

Public contact
Name of contact person	Tsutomu Fujii
Organization	Nagoya University Graduate School of Medicine
Division name	Gastroenterological Surgery (Surgery II)
Address	65,Tsurumai-cho,Showa-ku,Nagoya,Aichi, Japan
TEL	052-744-2245
Homepage URL
Email	fjt@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
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	名古屋大学医学部附属病院（愛知県）、関西医科大学（大阪府）

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 09 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 01 Month 01 Day
Anticipated trial start date	2015 Year 01 Month 01 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	2015 Year 11 Month 09 Day
Last modified on	2018 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022775