A randomized phase III study of oxaliplatin based chemotherapy versus combination chemotherapy of TS-1,irinotecan and bevacizumab as first line therapy for unresectable or recurrent colorectal cancer

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2012
INTERVENTION: arm A‐1:mFOLFOX6+Bevacizumab Bevacizumab 5mg/kg/bi‐week L‐OHP 85mg/m2/bi‐week l‐LV 200mg/m2/bi‐week 5‐FU/bolus 400mg/m2/bi‐week 5‐FU/infusional 2,400mg/m2/bi‐week arm A‐2: CapeOX+Bevacizumab Bevacizumab 7.5mg/kg/tri‐week L‐OHP 130mg/m2/tri‐week Capecitabine 1200‐2100mg/twice/day(day 1‐15) arm B‐1:TS‐1/CPT‐11+Bevacizumab(SIRB) Bevacizumab 7.5mg/kg/tri‐week CPT‐11 150mg/m2/tri‐week S‐1 40‐60mg/twice/day(day1‐15)/tri‐week arm B‐2:TS‐1/CPT‐11+Bevacizumab(IRIS/BV) Bevacizumab 5mg/kg/(day1and15)/4‐weeks CPT‐11 100mg/m2/(day1and15)/4‐weeks S‐1 40‐60mg/twice/day(day1‐15)/4weeks CONDITION: unresectable or recurrent colorectal cancer PRIMARY OUTCOME: Progression free survival(PFS) SECONDARY OUTCOME: Overall survival(OS); Response rate(RR); Time to treatment failure(TTF); Relative dose intensity(RDI); Safety; Quality of life(QOL); Quality adjusted life years(QALY); Health economics; Translational research INCLUSION CRITERIA: 1.Histologically proven colorectal cancer (Adenocarcinoma) 2.Unresectable advanced/recurrent colorectal cancer 3.Aged over 20 years at the time of registration 4.Performance status(ECOG) :0,1 5.Patients with evaluable lesion 6.Previously not treated (chemotherapy, radiotherapy, etc.) for unresectable colorectal cancer 7.Able to receive oral treatment 8.Adequate organ function 9.Life expectancy estimated>=3 months 10.Written IC
Epistemonikos ID: d9e0ab5ba85ff65217dd97c3607f80bd25ce6b3f
First added on: Aug 22, 2024