Philadelphia, Pennsylvania 19107


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: 1. Diagnosis: Subjects with a diagnosis of recurrent head and neck cancer 2. Based on clinical and radiographic evidence the tumor needs to be deemed resectable preoperatively 3. Age: Subjects must be ≥ 18 years of age and ≤ 90 years old 4. Informed Consent: All subjects must be able to comprehend and sign a written informed consent document Exclusion Criteria: 1. Subjects who are pregnant or may become pregnant 2. Unresectable tumor 3. 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


NCT ID:

NCT02467738


Primary Contact:

Principal Investigator
Adam Luginbuhl, MD
Thomas Jefferson University

Adam Luginbuhl, MD
Email: axl010@jefferson.edu


Backup Contact:

Elizabeth Duddy, RN
Phone: 215-503-6828


Location Contact:

Philadelphia, Pennsylvania 19107
United States

Adam Luginbuhl, MD
Email: axl010@jefferson.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.