This early phase I trial studies how well cesium Cs-131 permanent interstitial brachytherapy works in treating patients with high risk head and neck cancer that has come back (recurrent) and can be removed by surgery. Interstitial brachytherapy is a form of radiation therapy that uses radioactive seeds and implants them directly into the tissue on a specific location of your body.
Additional locations may be listed on ClinicalTrials.gov for NCT02794675.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. Assess the impact of cesium Cs-131 (cesium 131) on disease free survival (DFS).
SECONDARY OBJECTIVES:
I. Assess complications associated with cesium 131 treatment in subjects with head and neck cancer.
II. Assess safety and tolerability of cesium 131 treatment and assess the potential complication to ensure the morbidity cost does not overshadow any measurable oncologic cure.
OUTLINE:
Patients undergo implantation of cesium Cs-131 brachytherapy seeds at the time of surgery.
After completion of study, patients are followed up every 2 months for the first year, every 3-4 months for the second year, and at 90 days, 3 months, 12 months, and 24 months.
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorMin Yao
