Surgical Resection and Intraoperative Cesium-131 Brachytherapy for Head and Neck Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study Using Surgical Resection and Intraoperative Cesium-131 Permanent Interstitial Brachytherapy Implant in Resectable Recurrent Head and Neck Cancer

Conditions
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Recurrent Head and Neck Carcinoma

Intervention / Treatment
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* Radiation: Brachytherapy
* Drug: Cesium-131
* Procedure: Conventional surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Subjects who are pregnant or may become pregnant Unresectable tumor 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cesium-131 Brachytherapy<br>Patients undergo brachytherapy using Cesium-131 during surgical resection | Radiation: Brachytherapy<br>* Undergo brachytherapy with Cesium-131<br>Drug: Cesium-131<br>* Undergo brachytherapy with Cesium-131<br>Procedure: Conventional surgery<br>* Undergo surgical resection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate | Comparisons of 6-month and one-year recurrence rates will be performed using logistic regression | 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. | Up to 24 months | 
| Complication rate | Estimated by cohort along with exact 95% confidence intervals | 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 | Up to 30 days |