Unique ID issued by UMIN | UMIN000027633 |
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Receipt number | R000031637 |
Scientific Title | Randomized phase II study of neoadjuvant chemoradiotherapy (S-1+radiation) for resectable pancreatic cancer with less than 180 degree portal vein abutment |
Date of disclosure of the study information | 2017/07/01 |
Last modified on | 2018/01/31 22:35:47 |
Randomized phase II study of neoadjuvant chemoradiotherapy (S-1+radiation) for resectable pancreatic cancer with less than 180 degree portal vein abutment
Randomized phase II study of neoadjuvant chemoradiotherapy (S-1+radiation) for resectable pancreatic cancer with less than 180 degree portal vein abutment
Randomized phase II study of neoadjuvant chemoradiotherapy (S-1+radiation) for resectable pancreatic cancer with less than 180 degree portal vein abutment
Randomized phase II study of neoadjuvant chemoradiotherapy (S-1+radiation) for resectable pancreatic cancer with less than 180 degree portal vein abutment
Japan |
resectable pancreatic cancer with less than 180 degree portal vein abutment
Hepato-biliary-pancreatic surgery |
Malignancy
NO
To evaluate the local control efficacy of neoadjuvant chemoradiotherapy with S-1 for resectable pancreatic cancer with less than 180 degree portal vein abutment.
Efficacy
Local recurrence rate within 2 years after surgery
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine | Maneuver |
ArmA; Neoadjuvant chemotherapy group
S-1: 80mg/m2/day, 2 weeks administration followed by 1 week withdrawl and 2 weeks administration, for a total of 5 weeks.
Radiotherapy: 1.8 Gy/day, 28days, a total of 50.4Gy
Arm B: Surgery group without neoadjuvant therapy
20 | years-old | <= |
75 | years-old | >= |
Male and Female
(1) Patients diagnosed with pancreatic cancer
(2) Patients without distant metastasis, M0 (UICC8th TNM)
(3) Resectable pancreatic cancer by NCCN guideline (Version 2. 2016) with less than180 degree portal vein abutment and without encasement
(4) ECOG PS 0-1
(5) No prior therapy for pancreatic cancer
(6) Patients without active cancer of other organs
(7) Patients who can intake orally
(8) Main organs function test almost within normal range
(9) Patients who fully understand the study procedures and consent the document voluntary after an adequate explanation
(1) Patients who have allergies to S-1
(2) Patients who have active infection
(3) Patients with active peptic ulcer
(4) Patients with ileus
(5) Patients with Grade>=2 diarrhea according to CTCAE v4.0
(6) Patients with uncontrolled ascites or pleural effusion
(7) Patients with flucytosine, phenytoin, or warfarin potassium administration
(8) Patients with serious comorbid conditions
(9) Patients with pregnancy
(10) Patients with serious psychiatric diseases
(11) Patients who were deemed inappropriate for medical reasons
56
1st name | |
Middle name | |
Last name | Yasuhiro Kodera |
Nagoya University, Graduate School of Medicine
Gastroenterorogical Surgery
65 Tsurumai-cho Showa-ku Nagoya city
052-744-2253
ykodera@med.nagoya-u.ac.jp
1st name | |
Middle name | |
Last name | Suguru Yamada |
Nagoya University, Graduate School of Medicine
Gastroenterorogical Surgery
65 Tsurumai-cho Showa-ku Nagoya city
052-744-2253
suguru@med.nagoya-u.ac.jp
Nagoya University, Graduate School of Medicine
Nagoya University, Graduate School of Medicine
Other
NO
2017 | Year | 07 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2017 | Year | 06 | Month | 01 | Day |
2017 | Year | 07 | Month | 01 | Day |
2017 | Year | 06 | Month | 04 | Day |
2018 | Year | 01 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031637
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