Recurrent Head and Neck Carcinoma Clinical Trial
Official title:
A Pilot Study Using Surgical Resection and Intraoperative Cesium-131 Permanent Interstitial Brachytherapy Implant in Resectable Recurrent Head and Neck Cancer
Verified date | July 2023 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | May 28, 2020 |
Est. primary completion date | August 3, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: 1. Diagnosis: Subjects with a diagnosis of recurrent head and neck cancer 2. Based on clinical and radiographic evidence the tumor needs to be deemed resectable preoperatively 3. Age: Subjects must be = 18 years of age and = 90 years old 4. Informed Consent: All subjects must be able to comprehend and sign a written informed consent document Exclusion Criteria: 1. Subjects who are pregnant or may become pregnant 2. Unresectable tumor 3. 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 |
Country | Name | City | State |
---|---|---|---|
United States | Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Cancer Center at Thomas Jefferson University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Recurrence rate | Comparisons of 6-month and one-year recurrence rates will be performed using logistic regression | Up to 24 months | |
Secondary | 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 | |
Secondary | Complication rate | Estimated by cohort along with exact 95% confidence intervals | Up to 24 months | |
Secondary | 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 |
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