A Phase II Study Examining the Feasibility of Long Term and Low Dose Oral Capecitabine (Xeloda®) in Newly Diagnosed Head and Neck Squamous Cell Carcinoma After Surgery, Radiation and/or Chemotherapy
- Determine the feasibility of adjuvant low-dose capecitabine in patients with squamous
cell carcinoma of the head and neck who have undergone prior curative surgery,
radiotherapy, and/or chemotherapy.
- Determine the time to recurrence, local-regional control, and survival rate in patients
treated with this drug.
- Determine the incidence of second primary tumors in patients treated with this drug.
OUTLINE: This is an open-label study.
Patients receive oral capecitabine once daily for 1 year in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility of treatment as assessed within 365 days
George H. Yoo, MD
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|