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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-112 | Other Identifier | CCRRC | |
| JT 7243 | Other Identifier | JeffTrial Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cesium-131 Brachytherapy | Experimental | Patients undergo brachytherapy using Cesium-131 during surgical resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brachytherapy | Radiation | Undergo brachytherapy with Cesium-131 |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Luginbuhl, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34900741 | Derived | Luginbuhl A, Calder A, Kutler D, Zender C, Wise-Draper T, Patel J, Cheng M, Karivedu V, Zhan T, Parashar B, Gulati S, Yao M, Lavertu P, Takiar V, Tang A, Johnson J, Keane W, Curry J, Cognetti D, Bar-Ad V. Multi-Institutional Study Validates Safety of Intraoperative Cesium-131 Brachytherapy for Treatment of Recurrent Head and Neck Cancer. Front Oncol. 2021 Nov 26;11:786216. doi: 10.3389/fonc.2021.786216. eCollection 2021. |
| Label | URL |
|---|---|
| Jefferson University Hospitals | View source |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| C000614985 | Cesium-131 |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Cesium-131 |
| Drug |
Undergo brachytherapy with Cesium-131 |
|
| Conventional surgery | Procedure | Undergo surgical resection |
|
| 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 |