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ERMES: FOLFIRI + Cetuximab Strategy in mCRC
NCT02484833Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2015
- Primary completion
- Dec 2019
- Countries
- 1
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- cetuximab
- Conditions
- metastatic colorectal cancer (mCRC)
01
Overview
Phase 3, randomised, open-label trial of cetuximab in metastatic colorectal cancer (mCRC) (2 arms). Primary endpoints: Progression-free survival at 48 months and Incidence of grade 3-4 Adverse Events at 48 months. Started Feb 2015; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Continuous FOLFIRI + Cetuximab
FOLFIRI + Cetuximab until disease progression
Cetuximab Maintenance
FOLFIRI + Cetuximab for 8 cycles followed by Cetuximab alone
03
Who it enrols
Patients with histologically proven metastatic colorectal adenocarcinoma, RAS and BRAF wild-type, ECOG PS 0-2, and no prior chemotherapy for metastatic disease.
04
Endpoints
Primary
Progression-free survival
Incidence of grade 3-4 Adverse Events
Secondary
Response rate
Early tumor shrinkage
Overall survival
Cetuximab-related skin toxicity
Safety profile
Quality of life
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