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Safety comformation study of R435 (Bevacizumab) in patients with metastatic colorectal cancer

ABSTRACT: Intervention name : Bevacizumab Dosage And administration of the intervention : Injection Primary outcome(s): Safety Study Design: Open, Single Arm study

DISEASE(S): Metastatic Colorectal Cancer

PROVIDER: 2609945 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Phase I/II study of R435 (Bevacizumab) in patients with metastatic colorectal cancer

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Safety comformation study of R435 (Bevacizumab) in patients with metastatic colorectal cancer

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

Project description: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

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Project description: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

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