Intraoperative Placement of Cesium-131 Permanent Interstitial Brachytherapy in Head and Neck Cancer
NCT02794675 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2020-12-23
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.
Conditions
Interventions
- DRUG
-
Cesium 131
The number sources and activity will be based on the target volume to deliver total radiation dose, this will vary per patient.
Sponsors & Collaborators
-
Case Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
Min Yao, MD · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-12-21
- Primary Completion
- 2020-07-24
- Completion
- 2020-07-24
- FDA Drug
- Yes
Countries
- United States
Study Locations
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