Clinical Trial: S0225 Capecitabine in Treating Patients Who Have Undergone Surgery for Locally Recurrent or Persistent Head and Neck Cancer
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
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
Brief Summary:
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.
Detailed Summary:
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.
Sponsor: Southwest Oncology Group
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Southwest Oncology Group
Dates:
Date Received: November 5, 2004
Date Started:
Date Completion:
Last Updated: November 7, 2013
Last Verified: November 2013
