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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-17

Study Completion Date

2020-05-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Recurrent Head and Neck Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cesium-131 Brachytherapy

Patients undergo brachytherapy using Cesium-131 during surgical resection

Group Type EXPERIMENTAL

Brachytherapy

Intervention Type RADIATION

Undergo brachytherapy with Cesium-131

Cesium-131

Intervention Type DRUG

Undergo brachytherapy with Cesium-131

Conventional surgery

Intervention Type PROCEDURE

Undergo surgical resection

Interventions

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Brachytherapy

Undergo brachytherapy with Cesium-131

Intervention Type RADIATION

Cesium-131

Undergo brachytherapy with Cesium-131

Intervention Type DRUG

Conventional surgery

Undergo surgical resection

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No