Ph II Long Term/Low Dose Xeloda in Head and Neck Squamous Cell Carcinoma After Surgery, Radiation & or Chemo
- Conditions
- Head and Neck Cancer
- Interventions
- Procedure: Surgery, chemotherapy and/or radiotherapy
- Registration Number
- NCT00258310
- Lead Sponsor
- Barbara Ann Karmanos Cancer Institute
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving capecitabine after surgery, radiation therapy, and/or chemotherapy may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well capecitabine works in treating patients who have undergone previous surgery, radiation therapy, and/or chemotherapy for head and neck cancer.
- Detailed Description
OBJECTIVES:
Primary
* 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.
Secondary
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Capecitabine capecitabine Surgery, chemotherapy and/or radiotherapy, prior to administration of Capecitabine 1000mg/day for one year. Capecitabine Surgery, chemotherapy and/or radiotherapy Surgery, chemotherapy and/or radiotherapy, prior to administration of Capecitabine 1000mg/day for one year.
- Primary Outcome Measures
Name Time Method Compliance With Treatment . within 365 days Compliance is defined as taking at least 80% of the prescribed dose for one year.
- Secondary Outcome Measures
Name Time Method Recurrence-free Survival Within 3 years of end of study. Time to recurrence or death
Overall Survival Within 3 years of end of study Estimated time from study entry to death from any cause
Incidence of Second Primary Tumors Within 3 years of end of study
Trial Locations
- Locations (1)
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States