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Completed

NCT Number: NCT02467738

Surgical Resection and Intraoperative Cesium-131 Brachytherapy for 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.

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Key information

Conditions

Recurrent Head and Neck Carcinoma

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis: Subjects with a diagnosis of recurrent head and neck cancer
  • Based on clinical and radiographic evidence the tumor needs to be deemed resectable preoperatively
  • Age: Subjects must be ≥ 18 years of age and ≤ 90 years old
  • Informed Consent: All subjects must be able to comprehend and sign a written informed consent document

Exclusion criteria

  • Subjects who are pregnant or may become pregnant
  • Unresectable tumor
  • 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

Treatment and study plan

Brachytherapy

Radiation

Undergo brachytherapy with Cesium-131

Cesium-131

Drug

Undergo brachytherapy with Cesium-131

conventional surgery

Procedure

Undergo surgical resection

Primary outcomes

  1. Disease free survival (DFS)

    Time frame: Up to 24 months

    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

  2. Incidence of toxicity

    Time frame: Up to 90 days

    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.

Secondary outcomes

  1. Recurrence rate

    Time frame: Up to 24 months

    Comparisons of 6-month and one-year recurrence rates will be performed using logistic regression

  2. Overall survival

    Time frame: Up to 24 months

    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.

  3. Complication rate

    Time frame: Up to 24 months

    Estimated by cohort along with exact 95% confidence intervals

  4. Adverse event rate

    Time frame: Up to 30 days

    Evaluated using the National Cancer Institute, Common Terminology Criteria for Adverse Events version 4.0

    Estimated by cohort along with exact 95% confidence intervals

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jun 10, 2015
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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