Head and Neck Cancer Clinical Trial
Official title:
Phase II Study Evaluating Radiotherapy-chemotherapy and Cetuximab in Patients With Histologically Proven Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Hypopharynx, or Larynx and With a Poor Prognosis After Complete Surgical Resection
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such
as cetuximab, can block tumor growth in different ways. Some block the ability of tumor
cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing
substances to them. Giving chemotherapy together with radiation therapy and cetuximab may
kill more tumor cells.
PURPOSE: This phase II trial is studying how well chemotherapy given together with radiation
therapy and cetuximab works in treating patients with head and neck cancer.
OBJECTIVES:
Primary
- Evaluate disease-free survival at 2 years in patients with poor prognosis squamous cell
carcinoma of the head and neck treated with chemoradiotherapy and cetuximab after
complete surgical resection.
Secondary
- Evaluate quality of life.
- Evaluate tolerability.
- Evaluate overall survival.
- Analyze germinal polymorphisms.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV on day 1. Treatment with cetuximab repeats every week for up
to 8 courses. Patients also receive cisplatin IV on day 8. Treatment with cisplatin repeats
every 3 weeks for up to 3 courses. Patients undergo concurrent radiotherapy 5 times a week
for 7 weeks beginning on day 8.
After completion of study treatment, patients are followed at 1 month and then every 3
months for 2 years.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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