Unique ID issued by UMIN | UMIN000017115 |
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Receipt number | 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 14:00:52 |
Inverse Probability of Treatment Weighting Analysis of Upfront Surgery versus Neoadjuvant Chemoradiotherapy followed by Surgery for Pancreatic Adenocarcinoma with Arterial Abutment
NACRT for PDAC abutted with the artery
Inverse Probability of Treatment Weighting Analysis of Upfront Surgery versus Neoadjuvant Chemoradiotherapy followed by Surgery for Pancreatic Adenocarcinoma with Arterial Abutment
NACRT for PDAC abutted with the artery
Japan |
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).
Hepato-biliary-pancreatic surgery |
Malignancy
NO
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).
Efficacy
Survival, short-term clinic benefit, the effect of NACRT, adverse events
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
Neoadjuvant chemoradiotherapy
Upfront surgery
20 | years-old | <= |
85 | years-old | > |
Male and Female
(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
(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.
92
1st name | |
Middle name | |
Last name | Yasuhiro Kodera |
Nagoya University Graduate School of Medicine
Gastroenterological Surgery (Surgery II)
65,Tsurumai-cho,Showa-ku,Nagoya,Aichi
052-744-2245
fjt@med.nagoya-u.ac.jp
1st name | |
Middle name | |
Last name | Tsutomu Fujii |
Nagoya University Graduate School of Medicine
Gastroenterological Surgery (Surgery II)
65,Tsurumai-cho,Showa-ku,Nagoya,Aichi
052-744-2245
fjt@med.nagoya-u.ac.jp
Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine
Nagoya University Graduate School of Medicine
NO
2015 | Year | 04 | Month | 13 | Day |
Unpublished
Main results already published
2000 | Year | 01 | Month | 01 | Day |
2000 | Year | 03 | Month | 01 | Day |
2015 | Year | 04 | Month | 13 | Day |
2015 | Year | 10 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019855
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