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Intraoperative Placement of Cesium-131 Permanent Interstitial Brachytherapy in Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:
A Pilot Study Using Intraoperative Placement of Cesium-131 Permanent Interstitial Brachytherapy in Resectable High Risk Recurrent Head and Neck Cancer

Clinical Trial Summary

The purpose of this study is to explore the use of a treatment called interstitial brachytherapy for patients who have a high risk resectable (able to be treated with surgery) recurrent head and neck cancer. Brachytherapy is a form of radiation therapy that uses radioactive seeds and implants them into a specific place on your body. This study is using Cesium-131 permanent interstitial brachytherapy. Cesium-131 is FDA approve for brachytherapy use, however, there are currently no research studies to show how effective it is for head and neck cancer. The goal of this study is determine the effect that the placement of Cesium-131 brachytherapy seeds has on overall survival as well as to assess possible side effects.

Clinical Trial Description

Primary Objective: To assess the effect of Cesium 131 brachytherapy in subjects with resectable recurrent cancer of the head and neck by evaluating disease free survival (DFS) and comparing to a previous cohort. Potential effects on locoregional control rate and overall survival will be explored. Secondary Objective: To assess toxicity associated with cesium 131 brachytherapy treatment. Study Design Patients with a head and neck recurrent cancer who are planned to undergo definitive tumor resection surgery that meet our inclusion and exclusion criteria will be offered participation in this clinical trial. Participant's Follow-up. The participant's medical records will be reviewed every 3 months for 24 months to assess: loco-regional control, distant metastasis free survival, disease free survival, and overall survival. This will allow us to assess the potential treatment effect of cesium 131. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02794675
Study type Interventional
Source Case Comprehensive Cancer Center
Contact
Status Completed
Phase Early Phase 1
Start date December 21, 2016
Completion date July 24, 2020
View Details
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