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
OBJECTIVES:
Primary
- 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.
Secondary
- To determine the progression-free survival and local-regional progression in these
patients.
- 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
crude survival
1-year crude survival
one year
No
Lucien A. Nedzi, MD
Principal Investigator
Simmons Cancer Center
United States: Food and Drug Administration
CDR0000632295
NCT00833261
December 2008
December 2018
Name | Location |
---|---|
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 |