NCT04034459

FOLFOXIRI Plus Cetuximab vs. FOLFOXIRI Plus Bevacizumab 1st-line in BRAF-mutated mCRC

Randomised Study to Investigate FOLFOXIRI Plus Cetuximab vs. FOLFOXIRI Plus Bevacizumab as First-line Treatment of BRAF-mutated Metastatic Colorectal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Once randomisation has been completed, the study treatment should be started preferably immediately; at the latest within one week following randomisation. The patients will be randomised in a ratio of 1:2 to the following two treatment arms. Patients in both treatment arms will receive standard chemotherapy with FOLFOXIRI as background treatment, which can be de-escalated to FOLFIRI in case of toxicity. Standard arm A: The patient will be treated with FOLFOXIRI plus bevacizumab for up to 12 cycles (24 weeks) or until progression (if the latter occurs before completing the 12 cycles). Within the 12 cycles, the FOLFOXIRI plus bevacizumab regimen may be de-escalated, owing to toxicity, to FOLFIRI and bevacizumab at the treating physician's discretion. After 12 cycles of the study treatment, a switch to a maintenance regimen with a fluoropyrimidine (5-FU infusion or capecitabine) plus bevacizumab, administered until progression occurs, is recommended. The recommended maintenance phase of the study is not part of the study treatment. However, maintenance therapy will be counted as first-line therapy. Experimental arm B: The patient will be treated with FOLFOXIRI plus weekly administration of cetuximab for up to 12 cycles (24 weeks) or until progression (if the latter occurs before completing the 12 cycles). Within the 12 cycles, the FOLFOXIRI plus cetuximab regimen may be de-escalated owing to toxicity, to FOLFIRI and cetuximab at the treating physician's discretion. After 12 cycles, a switch to a maintenance regimen with 5-FU and cetuximab or with irinotecan and cetuximab, administered until progression occurs, is recommended. The recommended maintenance phase of the study is not part of the study treatment. However, maintenance therapy will be counted as first-line therapy.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab	Bevacizumab 5 mg/kg BW iv over 30 to 90\* min day 1
DRUG	Irinotecan	Irinotecan 150 mg/m² iv, 30 - 90 min. day 1
DRUG	Folinic acid	Folinic acid (racemic) 400 mg/m² iv, 120 min. day 1
DRUG	Oxaliplatin	Oxaliplatin 85mg/m² day 1
DRUG	5-FU	5-FU 3000 mg/m² iv over 48 h days 1-2
DRUG	Cetuximab	Cetuximab initially 400 mg/m² with infusion rate of ≤5 mg/min., subsequently 250 mg/m² iv with infusion rate of ≤10 mg/min. days 1+8

Timeline

• Start date: 2016-11-25
• Primary completion: 2023-11-01
• Completion: 2023-12-31
• First posted: 2019-07-26
• Last updated: 2023-11-14

Locations

1 site across 1 country: Germany