This pilot clinical trial studies cesium Cs 131 brachytherapy in treating patients with head and neck cancer that has come back (recurrent) and can be removed by surgery. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Radioactive drugs, such as cesium Cs 131, may carry radiation directly to tumor cells and not harm normal cells. Permanently implanting cesium Cs 131 into the wound bed after surgery may help treat microscopic cancer cells that may be in the tissue after surgical removal of the tumor.
PRIMARY OBJECTIVES: I. Assess the impact of cesium 131 (cesium Cs 131) on recurrence rate, disease free survival and over all survival. SECONDARY OBJECTIVES: I. Assess complications associated with cesium 131 treatment in subjects with head and neck cancer. OUTLINE: Patients undergo brachytherapy using cesium Cs 131 during surgical resection. After completion of study treatment, patients are followed up at 30 days and then every 3 months for 24 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Undergo brachytherapy with Cesium-131
Undergo brachytherapy with Cesium-131
Undergo surgical resection
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Disease free survival (DFS)
Will assess the impact of cesium Cs 131 on DFS by comparing the cohort to a matched historical control cohort. The distribution of DFS will be estimated using the Kaplan-Meier and a stratified log rank test will be used to test for differences between cohorts. Adjustment for other potential confounders will be performed using stratified Cox proportional hazards regression
Time frame: Up to 24 months
Incidence of toxicity
Evaluated using the Radiation Therapy Oncology Group Common Toxicity Criteria Categories of risk include infection, wound breakdown, inability to heal, fistula formation, bleeding and need for further surgery.
Time frame: Up to 90 days
Recurrence rate
Comparisons of 6-month and one-year recurrence rates will be performed using logistic regression
Time frame: Up to 24 months
Overall survival
The distribution of overall survival will be estimated using the Kaplan-Meier and a stratified log rank test will be used to test for differences between cohorts. Adjustment for other potential confounders will be performed using stratified Cox proportional hazards regression.
Time frame: Up to 24 months
Complication rate
Estimated by cohort along with exact 95% confidence intervals
Time frame: Up to 24 months
Adverse event rate
Evaluated using the National Cancer Institute, Common Terminology Criteria for Adverse Events version 4.0 Estimated by cohort along with exact 95% confidence intervals
Time frame: Up to 30 days
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