Cetuximab and Stereotactic Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery
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.
Head and Neck Cancer
Radiation: stereotactic body radiation therapy
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Official Title:||Re-irradiation and Stereotactic Cetuximab in Patients With Recurrent Carcinoma of the Head and Neck|
- Percentage of patients with nonprogressive disease at 12 months according to RECIST criteria [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
- Evaluate local control at 12 months in patients with recurrent squamous cell carcinoma of the head and neck treated with cetuximab and stereotactic radiotherapy.
- 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.