GOTIC-002 Metronomic Maintenance Chemotherapy after Chemoradiotherapy for Locally Advanced Cervix Cancer Long UFT Administration Trial (LUFT Trial)
Metr Me trono onomi mic Che hemot mother herapy apy Co Contin inuous ad admin inis istrat atio ion (w (wit ithout in interva val) l) of f lo low d dose o of f cytotoxic ic dr drug w wil ill l pr provid ide anti-an angio iogenet etic ic eff ffect, a , and d tumor dorman do ancy c y can an be be o obt btai ained. d. Propo posed by d by Kerbe bel an and d Folk lkman an
UFT: : Mechani hanism sm of A f Action ion UFT H O N N O O + NH NH F O O Uracli Tegafur ( FT ) Cytotoxic Effect H O O N O HO OH OH + TS NH FdUMP F Anti- inhibition O angiogenetic F-RNA 5-FU FUTP effect O O HO COOH GHB GBL ( γ -hydroxybutyric acid ) ( γ -butyrolactone )
GOT OTIC IC-002 002 Randomi Ra omized zed Phase se III Tri Trial o l of Long g UF UFT T adminis inistra tration ion foll llowi wing ng curative ive radia iation ion therap apy y for lo locall lly advance anced d cervic ical al cancer er
Trial ial Sche hema ma Cervical ical Cancer ancer FIGO GO Ib2 Ib2-IVa IVa 期 Target Accrual After er Chem emorad radiatio iation 530 → 350 Current 264 Regi gistratio stration Random andomizat izatio ion Stratifi atifica catio ion : Sta Stage ge (Ib2,II vs III,IV a )、 In Insti tituti tution on Observation UFT 300mg or 400mg / day bid 24 months
End ndpoints points Primary Endpoint: PFS Secondary Endpoints: OS Toxicity Quality of Life ( QOL ) Cost Effectiveness
Recommend
More recommend