Radiation Therapy and Cetuximab in Treating Patients With Recurrent Head and Neck Cancer
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.
Head and Neck Cancer
Radiation: stereotactic body radiation therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30 [ Time Frame: Daily while on Treatment ] [ Designated as safety issue: Yes ]
- Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Local and Distant Control [ Time Frame: very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter. ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5
Given IVRadiation: stereotactic body radiation therapy
- To assess the toxicity of stereotactic body radiotherapy delivered concurrently with cetuximab in patients with recurrent squamous cell carcinoma of the head and neck.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00891904
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Anurag K. Singh, MD||Roswell Park Cancer Institute|