Status: Active, not recruiting
Condition: Recurrent Head and Neck Carcinoma
Study Type: Interventional
Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
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.
I. Assess the impact of cesium 131 (cesium Cs 131) on recurrence rate, disease free survival and over all survival.
I. Assess complications associated with cesium 131 treatment in subjects with head and neck cancer.
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.
Diagnosis: Subjects with a diagnosis of recurrent head and neck cancer
Based on clinical and radiographic evidence the tumor needs to be deemed resectable preoperatively
Age: Subjects must be ≥ 18 years of age and ≤ 90 years old
Informed Consent: All subjects must be able to comprehend and sign a written informed consent document
Subjects who are pregnant or may become pregnant
Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation, and in the judgment of the investigator would make the subject inappropriate for entry into this study
Healthy Volunteers: No
Min Age: 18 Years
Max Age: 90 Years
Sidney Kimmel Cancer Center at Thomas Jefferson University