Head and Neck Cancer Clinical Trial
Official title:
Re-irradiation and Stereotactic Cetuximab in Patients With Recurrent Carcinoma of the Head and Neck
RATIONALE: 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. Radiation therapy uses high-energy
x-rays to kill tumor cells. Stereotactic radiation therapy may be able to send x-rays
directly to the tumor and cause less damage to normal tissue. Giving cetuximab together with
stereotactic radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how giving cetuximab together with stereotactic
radiation therapy works in treating patients with recurrent squamous cell carcinoma of the
head and neck cancer that cannot be removed by surgery.
OBJECTIVES:
Primary
- Evaluate local control at 12 months in patients with recurrent squamous cell carcinoma
of the head and neck treated with cetuximab and stereotactic radiotherapy.
Secondary
- Determine the incidence of cutaneous toxicity.
- Assess the care and development of skin reactions.
- Determine the quality of life of patients treated with this drug.
- Determine tumor response at 2 months.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV once weekly for 5 weeks. Patients undergo stereotactic
radiotherapy 3 times weekly during weeks 2 and 3.
After completion of study therapy, patients are followed at 2 months and then every 3 months
for 2 years.
;
Allocation: Non-Randomized, Primary Purpose: Treatment
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