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RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Cisplatin and docetaxel may make the tumor cells more sensitive to radiation therapy. Giving chemoradiotherapy after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well adjuvant chemoradiotherapy using cisplatin and docetaxel works in treating patients with completely resected stage III or stage IV head and neck cancer.
- Determine the disease-free survival and overall survival of patients with high-risk stage III or IV squamous cell carcinoma of the head and neck treated with adjuvant chemoradiotherapy comprising docetaxel and cisplatin.
- Determine the toxicity of this regimen in these patients.
- Categorize the site(s) of disease relapse in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36 and cisplatin IV over 1.5 hours on days 1, 22, and 43. Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-45. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years from registration.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 17.5-23.5 months.
Masking: Open Label, Primary Purpose: Treatment
Head and Neck Cancer
cisplatin, docetaxel, radiation therapy
USC/Norris Comprehensive Cancer Center and Hospital
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:54:19-0400
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