Unique ID issued by UMIN | UMIN000009634 |
---|---|
Receipt number | R000010813 |
Scientific Title | Phase II/III study of Gemcitabine and S-1 (GS therapy) as Neoadjuvant chemotherapy for resectable pancreatic cancer (Prep-02/JSAP-05) |
Date of disclosure of the study information | 2012/12/26 |
Last modified on | 2019/07/04 09:22:36 |
Phase II/III study of Gemcitabine and S-1 (GS therapy) as Neoadjuvant chemotherapy for resectable pancreatic cancer (Prep-02/JSAP-05)
Neoadjuvant GS therapy for pancreatic cancer : Prep-02/JSAP-05
Phase II/III study of Gemcitabine and S-1 (GS therapy) as Neoadjuvant chemotherapy for resectable pancreatic cancer (Prep-02/JSAP-05)
Neoadjuvant GS therapy for pancreatic cancer : Prep-02/JSAP-05
Japan |
Resectable pancreatic cancer
Hepato-biliary-pancreatic surgery |
Malignancy
NO
Phase II: To evaluate the equivalence of safety and resection rate for neoadjuvant GS therapy comparing standard therapy.
Phase III: To evaluate superiority in survival of neoadjuvant GS therapy against standard surgery-first therapy in patients with resectable pancreatic cancer
Safety,Efficacy
Confirmatory
Pragmatic
Phase II,III
Phase II: Resection rate
Phase III: Overall survival
Phase II: Adverse events
Phase III: Adverse events, Resection rate, Residual tumor, Nodal involvement rate, Histological response, Relapse-free survival, Tumor marker kinetics, Dose intensity, Patterns of Recurrence, Radiological tumor response
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
Neoadjuvant chemotherapy with gemcitabine and S-1 followed by surgery and adjuvant with 4 course of oral S-1 (Test arm).
Surgery and adjuvant with 4 course of oral S-1 (Control arm).
20 | years-old | <= |
79 | years-old | >= |
Male and Female
1) invasive ductal carcinoma of the pancreas
2) no distant metastasis
3) R0/1 resectable
4) all adult who anticipate to undergo pancreatectomy
5) no prior therapy
6) written informed consent
6) ECOG performance status of 0 or 1
7) Adequate organ function
8) Written informed consent
1) pulmonary fibrosis or interstitial pneumonitis
2) Uncontrolled watery diarrhea
3) Active double cancer
4) Active infection
5) HBs antigen positive
6) Pregnant females, possibly pregnant females
360
1st name | Michiaki |
Middle name | |
Last name | Unno |
Tohoku University Graduate School of Medicine
Division of gastroenterological surgery
980-8574
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
022-717-7205
m_unno@surg.med.tohoku.ac.jp
1st name | Fuyuhiko |
Middle name | |
Last name | Motoi |
Tohoku University Graduate School of Medicine
Surgery
980-8574
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
022-717-7205
http://www.surg.med.tohoku.ac.jp/society/prep02.html
fmotoi@surg.med.tohoku.ac.jp
Study group of preoperative therapy for pancreatic cancer (PREP)/Japanese Study Group of Adjuvant Therapy for pancreatic Cancer (JSAP)
Ministry of Health, Labour and Welfare
Japanese Governmental office
Japan
IRB of Tohoku Univ.
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
022-717-8007
rinri-2@proj.med.tohoku.ac.jp
NO
2012 | Year | 12 | Month | 26 | Day |
Published
https://meetinglibrary.asco.org/record/169433/abstract
364
Main results already published
2012 | Year | 12 | Month | 26 | Day |
2012 | Year | 11 | Month | 27 | Day |
2013 | Year | 01 | Month | 04 | Day |
2019 | Year | 01 | Month | 31 | Day |
2012 | Year | 12 | Month | 26 | Day |
2019 | Year | 07 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010813