Transcription of JCOG1202
1 Japan Clinical Oncology Group 29-A-3 JCOG JCOG1202 S-1 III ver. A phase III trial of S-1 vs. observation in patients with resected biliary tract cancer ASCOT Adjuvant S-1 for CholangiOcarcinoma Trial 277-8577 6-5-1 277-8577 6-5-1 047-8550 1 1-1 2012 6 23 JCOG PC1202 2013 7 29 JCOG 2013 12 5 ver.
2 JCOG 12 6 2015 8 25 ver. JCOG 8 28 2016 9 12 ver. JCOG 9 15 2017 7 20 ve . JCOG 7 21 JCOG1202 ver. 2/93 0. Vater S-1 Primary endpoint Overall survival Secondary endpoints Relapse free survival ( ) 1 ( ) Vater 2 UICC 7 Vater T2 -4 N0 M0 T1-4 N1 M0 T1 -4 N0 -1 M0 3 R R0 R1 4 20 80 5 Performance status PS ECOG 0 1 PS 6 CT 1 MRI 1 2 1 2
3 X 3 1 7) Vater D1 5 S4a5 Vater R0 1 20 80 PS 0 1 B S-1 4 2 4 A JCOG1202 ver. 3/93 8 9 2 14 10 70 2 10 10 11 12 13 14 2 1.
4 200 /mm3 10 104/mm3 g/dL mg/dL AST GOT 100 IU/L ALT GPT 100 IU/L mg/dL 50 mL/min * Cockcroft-Gault 50 mL/min 50 mL/min 50 mL/min Cockcroft-Gault Ccr 140- kg / 72 Cr mg/dL Ccr 140- kg / 72 Cr mg/dL 14 A B S-1 S-1 1 2 28 56 14 1 4 S-1 80 120 mg/body/ 1 2 day 1 28 day 29 42 m2 80 mg/day 20 mg x 4 cap m2 m2 100 mg/day 25 mg x 4 cap m2 120 mg/day 20 mg x 6 cap 350 4 5 1 10 3 ver.
5 70% 80% 350 440 90 1 11 ver. 440 5 5 1 11 3 JCOG1202 ver. 4/93 CRF JCOG JCOG
