Phase 2/3 study of fluoropyrimidine and irinotecan plus bevacizumab versus trifluridine/tipiracil plus bevacizumab as second-line for metastatic colorectal cancer (TRUSTY)

ABSTRACT: Intervention name : trifluridine/tipiracil INN of the intervention : trifluridine/tipiracil Dosage And administration of the intervention : Trifluridine/tipiracil was given in a dose of 35-75 mg twice daily (after breakfast and dinner) (70-150 mg/day) from after dinner on Day 1 to after breakfast on Day 6 and from after dinner on Day 8 to after breakfast on Day 13. Treatment was given orally for 5 consecutive days followed by a 2-day rest. This treatment was repeated twice, followed by a 14-day rest. This 28-day cycle was repeated until the criteria for withdrawal of the study treatment were met. Intervention name : bevacizumab INN of the intervention : bevacizumab Dosage And administration of the intervention : Bevacizumab 5 mg/kg was given as a 30-min continuous intravenous infusion on Day 1 and Day 15. Control intervention name : fluorouracil INN of the control intervention : fluorouracil Dosage And administration of the control intervention : [Treatment with FOLFIRI + bevacizumab] Fluorouracil 400 mg/m2 was given by rapid intravenous injection on Day 1, followed by a 46-h continuous intravenous infusion of 2400 mg/m2. Each cycle was 14 days, and treatment was repeated until the criteria for withdrawal of the study treatment were met. Control intervention name : TS-1(tegafur + gimeracil + oteracil potassium) INN of the control intervention : TS-1(tegafur + gimeracil + oteracil potassium) Dosage And administration of the control intervention : [Treatment with TS-1+ irinotecan +bevacizumab (3-week cycles) ] TS-1 is given orally in a dose of 40-60 mg twice daily (after breakfast and dinner) in accordance with body-surface area (80-120 mg/day), starting from after dinner on Day 1 to after breakfast on Day 15, followed by a 7-day rest. Each cycle was 21 days, and treatmen Primary outcome(s): efficacy Overall survival Study Design: Randomized, open-label, comparative study

DISEASE(S): Metastatic Colorectal Cancer

PROVIDER: 2611617 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR