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Reirradiation with Cetuximab for Relapsed Head and Neck Cancer
NCT00934518Phase 2
Key facts
- Status
- Withdrawn
- Start
- Jul 2009
- Primary completion
- Jul 2011
- Countries
- 1
- Sponsor
- Penn State Health Milton S. Hershey Medical Center
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- cetuximab
- Conditions
- squamous cell carcinoma of the head and neck (HNSCC)
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Overview
Phase 2, open-label, single-arm trial of cetuximab in squamous cell carcinoma of the head and neck (HNSCC), sponsored by Penn State Health Milton S. Hershey Medical Center. Primary endpoint: Incidence rate of acute and late toxicities at 5 years. Planned start Jul 2009; status: withdrawn.
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Design
1 arm- Study design
- Non-randomizedOpen-label
Radiation and Cetuximab
Image Guided Intensity Modulated Reirradiation with Concurrent Cetuximab
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Who it enrols
Patients with pathologically confirmed locoregional recurrence of squamous cell carcinoma of the head and neck who have received prior radiation therapy.
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Endpoints
Primary
Incidence rate of acute and late toxicities
Secondary
Overall Survival
Disease-Free Survival
Pattern of disease progression
Quality of Life
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