Intraoperative Placement of Cesium-131 Permanent Interstitial Brachytherapy in Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT02794675|
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : August 26, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Head and Neck Squamous Cell Carcinoma||Drug: Cesium 131||Early Phase 1|
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Using Intraoperative Placement of Cesium-131 Permanent Interstitial Brachytherapy in Resectable High Risk Recurrent Head and Neck Cancer|
|Actual Study Start Date :||December 21, 2016|
|Actual Primary Completion Date :||January 27, 2019|
|Actual Study Completion Date :||January 27, 2019|
Experimental: Cesium 131 brachytherapy
Cesium 131 is the radioactive isotope in the protocol. The prescribed dose will range from 50-80 Gy at maximal delivery. It comes in 0.5 cm seeds that will be placed in the tumor resection bed at 1cm intervals. They are implantable seeds that do not require removal.
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.
- Median disease free survival (DFS) [ Time Frame: Up to two years ]DFS defined as the time of diagnosis with no evidence of disease through death by any cause or relapse of disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794675
|United States, Ohio|
|University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Chad Zender, MD, FACS||University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|