NCT00891904

Radiation Therapy and Cetuximab in Treating Patients With Recurrent Head and Neck Cancer

A Feasibility Study of Re-irradiation Using Stereotactic Body Radiation Therapy (SBRT) and Cetuximab for Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. 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 stereotactic body radiation therapy together with cetuximab may kill more tumor cells. PURPOSE: This clinical trial is studying the side effects of radiation therapy given together with cetuximab and to see how well it works in treating patients with recurrent head and neck cancer.

Detailed description

OBJECTIVES: Primary * To assess the toxicity of stereotactic body radiotherapy delivered concurrently with cetuximab in patients with recurrent squamous cell carcinoma of the head and neck. Secondary * To assess the feasibility of delivering this regimen in these patients. * To assess the impact of this regimen on local control, distant control, and overall survival of these patients. OUTLINE: Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5. Patients undergo 1 fraction of stereotactic-body radiotherapy (RT) in week 2. At 4 weeks after RT completion, patients may receive additional cetuximab IV combined with a 28-day chemotherapy regimen, per investigator discretion. After completion of study treatment, patients are followed every 2 months for 1 year, every 3-4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
BIOLOGICAL	cetuximab	Given IV
RADIATION	stereotactic body radiation therapy	Undergoing Radiotherapy

Timeline

• Start date: 2009-04-01
• Primary completion: 2011-07-01
• First posted: 2009-05-01
• Last updated: 2016-04-14
• Results posted: 2014-03-12

Locations

1 site across 1 country: United States