Surgical Resection and Intraoperative Cesium-131 Brachytherapy for Head and Neck Cancer

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

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
• 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
• 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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Recurrent Head and Neck Carcinoma

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

External Links

•   Jefferson University Hospitals
•   Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center