UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000017115
Receipt No. R000019855
Scientific Title Inverse Probability of Treatment Weighting Analysis of Upfront Surgery versus Neoadjuvant Chemoradiotherapy followed by Surgery for Pancreatic Adenocarcinoma with Arterial Abutment
Date of disclosure of the study information 2015/04/13
Last modified on 2015/10/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Inverse Probability of Treatment Weighting Analysis of Upfront Surgery versus Neoadjuvant Chemoradiotherapy followed by Surgery for Pancreatic Adenocarcinoma with Arterial Abutment
Acronym NACRT for PDAC abutted with the artery
Scientific Title Inverse Probability of Treatment Weighting Analysis of Upfront Surgery versus Neoadjuvant Chemoradiotherapy followed by Surgery for Pancreatic Adenocarcinoma with Arterial Abutment
Scientific Title:Acronym NACRT for PDAC abutted with the artery
Region
Japan

Condition
Condition Pancreatic adenocarcinoma (PDAC) which were deemed borderline resectable through preoperative imaging due to abutment of the major artery, including the superior mesenteric artery (SMA) or common hepatic artery (CHA).
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 pancreatic adenocarcinoma (PDAC) which were deemed borderline resectable through preoperative imaging due to abutment of the major artery, including the superior mesenteric artery (SMA) or common hepatic artery (CHA).
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
85 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) Borderline resectable pancreatic cancer (NCCN criteria)
(5) abutment with the SMA or CHA
(6) Adequate hematologic, renal, hepatic and respiratory function
(7) Written informed consent
Key exclusion criteria (1) Resectable or unresectable pancreatic cancer (NCCN criteria)
(2)Tumors with encasement or stenosis of the arteries, those abutted with the celiac axis, and those only defined as BR diseases because of the superior mesenteric vein/PV factor
(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 92

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Kodera
Organization Nagoya University Graduate School of Medicine
Division name Gastroenterological Surgery (Surgery II)
Zip code
Address 65,Tsurumai-cho,Showa-ku,Nagoya,Aichi
TEL 052-744-2245
Email fjt@med.nagoya-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Tsutomu Fujii
Organization Nagoya University Graduate School of Medicine
Division name Gastroenterological Surgery (Surgery II)
Zip code
Address 65,Tsurumai-cho,Showa-ku,Nagoya,Aichi
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 04 Month 13 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 Main results already published
Date of protocol fixation
2000 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2000 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 13 Day
Last modified on
2015 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019855

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.