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DAHANCA 26: Paclitaxel + capecitabine with or without cetuximab in recurrent or metastatic head and neck squamous cell carcinoma
2014-001023-80Phase 2
Key facts
- Status
- Terminated
- Start
- Jan 2015
- Countries
- 1
- Sponsor
- Danish Head and Neck Cancer Group
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics
- Drugs
- cetuximab
- Conditions
- head and neck squamous cell carcinoma (HNSCC)
01
Overview
Phase 2, randomised, open-label trial of cetuximab in head and neck squamous cell carcinoma (HNSCC) (2 arms), sponsored by Danish Head and Neck Cancer Group. Primary endpoint: Tumor response (RECIST 1.1). Started Jan 2015; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Paclitaxel + capecitabine
Standard chemotherapy regimen of paclitaxel plus capecitabine as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma.
Paclitaxel + capecitabine + cetuximab
Combination of paclitaxel and capecitabine plus the EGFR-targeting monoclonal antibody cetuximab as first-line treatment.
03
Who it enrols
Adults with recurrent or metastatic squamous cell carcinoma of the head and neck and adequate performance status and organ function; patients with poor performance status or inadequate organ function are excluded.
04
Endpoints
Primary
Tumor response (RECIST 1.1)
Secondary
Progression-free survival
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