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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02467738
Other study ID # 15D.067
Secondary ID 2014-112
Status Completed
Phase Early Phase 1
First received
Last updated
Start date March 17, 2015
Est. completion date May 28, 2020

Study information

Verified date July 2023
Source Thomas Jefferson University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Brachytherapy
Undergo brachytherapy with Cesium-131
Drug:
Cesium-131
Undergo brachytherapy with Cesium-131
Procedure:
Conventional surgery
Undergo surgical resection

Locations

Country Name City State
United States Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

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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