Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity Clinical Trial
Official title:
S0225: Phase II Study of Adjuvant Low-Dose Capecitabine After Salvage Surgery in Patients With Locally Recurrent or Persistent Squamous Cell Carcinoma of the Head and Neck
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop
tumor cells from dividing so they stop growing or die. Giving capecitabine after surgery may
kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well capecitabine works in treating patients
who have undergone surgery for locally recurrent or persistenthead and neck cancer.
OBJECTIVES:
- Determine 2-year disease-free survival of patients treated with surgical salvage
followed by adjuvant low-dose capecitabine for locally recurrent or persistent squamous
cell carcinoma of the head and neck .
- Determine the toxic effects of this drug in these patients.
- Determine 2-year overall survival of patients treated with this drug.
- Determine patterns of disease relapse in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral capecitabine once daily for 12 months in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 2 years.
;
Primary Purpose: Treatment
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