NCT03279289

Study to Assess the Efficacy and Safety of Treatment With FOLFIRI-aflibercept Compared to Initial Treatment With FOLFIRI-aflibercept (for 6 Cycles) Followed by Maintenance With 5FU-aflibercept, in an Elderly Population With mCRC After Failure of an Oxaliplatin-based Regimen

Randomised, Multicentre, Phase II Pilot Study to Assess the Efficacy and Safety of Treatment With FOLFIRI-aflibercept Compared to Initial Treatment With FOLFIRI-aflibercept (for 6 Cycles) Followed by Maintenance With 5FU-aflibercept, in an Elderly Population With Metastatic Colorectal Cancer (mCRC) After Failure of an Oxaliplatin-based Regimen

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of treatment with FOLFIRI-aflibercept compared to initial treatment with FOLFIRI-aflibercept (for 6 cycles) followed by maintenance with 5FU-aflibercept, in an elderly population with metastatic colorectal cancer (mCRC) after failure of an oxaliplatin-based regimen

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Aflibercept	4 mg/kg administered intravenous infusion on day 1
DRUG	Irinotecan	180 mg/m2 intravenous infusion
DRUG	folinic acid (dl racemic)	400 mg/m2 intravenous infusion
DRUG	5Fluorouracil	400 mg/m2 intravenous bolus
DRUG	5-FU	2400 mg/m2 continuous intravenous infusion over 46 hours

Timeline

• Start date: 2017-10-25
• Primary completion: 2023-02-09
• Completion: 2023-02-09
• First posted: 2017-09-12
• Last updated: 2023-04-13

Locations

1 site across 1 country: Spain