Transcription of JCOG 1016
1 Japan Clinical Oncology Group 29-A-3 jcog JCOG1016 ACNU III ver. Phase III randomized Study in patients with ANaplastic glioma of radiotherapy with Temozolomide versus nimustine hydrochloride ACNU followed by temozolomide SANTA study P-III 162-8666 8-1 ( ) 162-8666 8-1 252 0375 1 15 1 2011 6 25 jcog PC1016 2014 3 18 jcog 2015 6 29 ver.
2 jcog 7 1 2018 10 15 ver. jcog 10 22 2018 11 22 ver. jcog JCOG1016 ver. 2/118 2019 1 24 2019 8 22 ver. jcog 2019 10 3 JCOG1016 ver. 3/118 0. 29 16 jcog ACNU III SANTA study (Phase-III) ACNU / TMZ ACNU-TMZ TMZ / TMZ Primary endpoint Secondary endpoints 1 a) PS 0-2(3)
3 , 20-69 3-20 PS IDH1A TMZ TMZ+ TMZ B ACNU TMZ ACNU+ ACNU TMZ / / / Grade III JCOG1016 ver. 4/118 b) 2 84 day 1 day 84 2 3 4 X-P 5 MRI 1 50% 1 MRI 6 MRI 2 2 MRI 7 MRI 2 2 MRI 8 60 Gy 1/3 9 10 3 20 3 3 3 20 11 20 69 12 Performance status PS ECOG 0 1 2 PS 3 PS 13
4 14 3 4 4 3 1,500 /mm3 g/dL 2 5 5 2 10 104 /mm3 AST GOT 120 IU/L ALT GPT 120 IU/L mg/dL 15 IDH1 R132H 16 A TMZ TMZ TMZ / B ACNU-TMZ JCOG1016 ver. 5/118 ACNU ACNU / TMZ 230 6 5 11 2 6 ver.
5 280 7 5 1 13 2 2014 5 29 2027 5 29 CRF jcog 16. 15. jcog jcog
