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

A Pilot Study Using Surgical Resection and Intraoperative Cesium-131 Permanent Interstitial Brachytherapy Implant in Resectable Recurrent Head and Neck Cancer

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Head and Neck Carcinoma
• Intervention / Treatment: Radiation: Brachytherapy; Drug: Cesium-131; Procedure: Conventional surgery

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Sidney Kimmel Cancer Center at Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cesium-131 Brachytherapy; Patients undergo brachytherapy using Cesium-131 during surgical resection	Radiation: Brachytherapy; Undergo brachytherapy with Cesium-131; Drug: Cesium-131; Undergo brachytherapy with Cesium-131; Procedure: Conventional surgery; Undergo surgical resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Investigators: Principal Investigator: Adam Luginbuhl, MD, Thomas Jefferson University

Publications and helpful links

General Publications

• 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.

Helpful Links

• Jefferson University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2015
• Primary Completion (Actual): May 28, 2020
• Study Completion (Actual): May 28, 2020

Study Registration Dates

• First Submitted: June 5, 2015
• First Submitted That Met QC Criteria: June 8, 2015
• First Posted (Estimated): June 10, 2015

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Therapeutics; Radiotherapy; Brachytherapy; Cesium-131
• Other Study ID Numbers: 15D.067; 2014-112 (Other Identifier: CCRRC); JT 7243 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No