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STRATEGIC-1: Multi-Line Therapy in Metastatic Colorectal Cancer
NCT01910610Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Oct 2013
- Primary completion
- Jul 2023
- Countries
- 3
- Sponsor
- GERCOR
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Conditions
- metastatic colorectal cancer (mCRC)
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Overview
Phase 3, randomised, open-label trial of bevacizumab, cetuximab and panitumumab in metastatic colorectal cancer (mCRC) (2 arms), sponsored by GERCOR. Primary endpoint: Duration of Disease Control up to 80 months. Started Oct 2013; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
STRATEGY A
FOLFIRI-cetuximab followed by oxaliplatin-based chemotherapy with bevacizumab
STRATEGY B
OPTIMOX-bevacizumab followed by irinotecan-based chemotherapy with bevacizumab followed by anti-EGFR mab
03
Who it enrols
Patients with histologically proven unresectable metastatic adenocarcinoma of the colon or rectum, wild-type RAS (KRAS and NRAS exons 2, 3, 4), and no prior therapy for metastatic disease.
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Endpoints
Primary
Duration of Disease Control
Secondary
Quality of Life
Overall Survival
Time to Failure of Strategy
Progression-Free Survival
Response Rate
Curative salvage surgery rate
Safety profile
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