UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019719 |
|---|---|
| Receipt number | R000022775 |
| Scientific Title | Estimating the Effects of Neoadjuvant Chemoradiotherapy for Adenocarcinoma of the Pancreatic Head using Inverse Probability of Treatment Weighting: A Dual-institution Observational Study |
| Date of disclosure of the study information | 2015/11/09 |
| Last modified on | 2018/07/25 14:50:03 |
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Basic information
Public title
Estimating the Effects of Neoadjuvant Chemoradiotherapy for Adenocarcinoma of the Pancreatic Head using Inverse Probability of Treatment Weighting: A Dual-institution Observational Study
Acronym
NACRT for PDAC
Scientific Title
Estimating the Effects of Neoadjuvant Chemoradiotherapy for Adenocarcinoma of the Pancreatic Head using Inverse Probability of Treatment Weighting: A Dual-institution Observational Study
Scientific Title:Acronym
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
| 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, Japan
TEL
052-744-2245
fjt@med.nagoya-u.ac.jp
Public contact
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, Japan
TEL
052-744-2245
Homepage URL
fjt@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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 |
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
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022775
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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