NCT03303495

A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC

A Multinational, Randomized, Phase III Study of FOLFIRI With/Without Bevacizumab Versus Irinotecan With/Without Bevacizumab As Second-line Therapy in Patients With Metastatic Colorectal Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to determine the non-inferiority of overall survival FOLFIRI with or without Bevacizumab compared with Irinotecan (CPT-11) with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.

Detailed description

Primary endpoint: Overall survival (OS), Secondary endpoints: Progression-free survival (PFS), Time to treatment failure (TTF), Overall response rate (ORR),Disease Control Rate (DCR), Safety.

Conditions

• Colorectal Neoplasms
• Neoplasm Metastasis
• Intestinal Neoplasms
• Gastrointestinal Neoplasms
• Digestive System Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	Bevacizumab	5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle.
DRUG	CPT-11	180 mg/m2 intravenously administered over 90 minutes on day 1 of a 2-week cycle
DRUG	5-FU Bolus	400 mg/m2 intravenous bolus on day 1 of a 2-week cycle.
DRUG	5-FU Infusion	2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle.
DRUG	l-LV (dl-LV)	200 (dl-LV: 400) mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.

Timeline

• Start date: 2011-11-14
• Primary completion: 2017-12-31
• Completion: 2018-12-31
• First posted: 2017-10-06
• Last updated: 2017-10-06

Locations

1 site across 1 country: China