A Randomized Phase III Trial of SOX/Bevacizumab versus FOLFOX/Bevacizmab in Treating Patients with Metastatic Colorectal Cancer (SOFT).

Intervention name : S-1 (tegafur + gimeracil + oteracil potassium)
INN of the intervention : S-1: tegafur, gimeracil, oteracil potassium
Dosage And administration of the intervention : 40-60 mg bid day 1 (evening) - day 15 (morning). Repeat cycles every 3 weeks
Intervention name : L-OHP (Oxaliplatin)
INN of the intervention : oxaliplatin
Dosage And administration of the intervention : 130 mg/m2 IV on day 1. Repeat cycles every 3 weeks
Intervention name : BV (Bevacizumab)
INN of the intervention : bevacizumab
Dosage And administration of the intervention : 7.5 mg/kg IV on day 1. Repeat cycles every 3 weeks
Control intervention name : 5-FU (Fluorouracil)
INN of the control intervention : fluorouracil
Dosage And administration of the control intervention : 400 mg/m2 IV bolus on day 1, followed by 2400 mg/m2 over 46 hours. Repeat cycles every 2 weeks.
Control intervention name : l-LV (Levofolinate calcium)
INN of the control intervention : folic acid
Dosage And administration of the control intervention : 200 mg IV on day 1. Repeat cycles every 2 weeks.
Control intervention name : L-OHP (Oxaliplatin)
INN of the control intervention : oxaliplatin
Dosage And administration of the control intervention : 85 mg/m2 IV on day 1. Repeat cycles every 2 weeks.
Control intervention name : BV (Bevacizumab)
INN of the control intervention : bevacizumab
Dosage And administration of the control intervention : 5 mg/kg IV on day 1. Repeat cycles every 2 weeks.
Primary outcome(s): Progression free survival(PFS)
Study Design: Randomized, open-label, comparative study