A Phase II Multi-Center Study of Concomitant Cetuximab and Cisplatin With Re-Irradiation Using Intensity-Modulated Radiotherapy in Patients With Recurrent Squamous Cell Carcinoma of the Head-and-Neck
- To evaluate whether treatment with cetuximab, cisplatin, and intensity-modulated
radiotherapy improves the overall survival of patients with recurrent squamous cell
carcinoma of the head and neck.
- To determine the progression-free survival and local-regional progression in these
- To identify and estimate the incidence rate of acute and late toxicities associated
with this treatment regimen.
- To determine the pattern of disease progression in these patients.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-7. Patients also
receive cisplatin IV over 60 minutes once weekly and undergo intensity-modulated
radiotherapy once daily 5 days a week in weeks 2-7.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 4 years.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
1-year crude survival
Lucien A. Nedzi, MD
Simmons Cancer Center
United States: Food and Drug Administration
|Medical College of Wisconsin||Milwaukee, Wisconsin 53226|
|University Hospitals of Cleveland||Cleveland, Ohio 44106|
|Baylor Research Institute||Dallas, Texas 75246|
|University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|