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

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status and phase: Completed; Early Phase 1

Conditions: Recurrent Head and Neck Carcinoma

Treatments: Procedure: Conventional surgery; Radiation: Brachytherapy; Drug: Cesium-131

Study type: Interventional

Funder types: Other

Identifiers

NCT02467738

JT 7243 (Other Identifier)

2014-112 (Other Identifier)

15D.067

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Cesium-131 Brachytherapy

Experimental group

Description:

Patients undergo brachytherapy using Cesium-131 during surgical resection

Treatment:

Drug: Cesium-131

Radiation: Brachytherapy

Procedure: Conventional surgery