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

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02467738
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 75.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Head and Neck Carcinoma	Radiation: Brachytherapy; Drug: Cesium-131; Procedure: Conventional surgery	Early Phase 1

Detailed Description

PRIMARY OBJECTIVES:

1. Assess the impact of cesium 131 (cesium Cs 131) on recurrence rate, disease free survival and over all survival.

SECONDARY OBJECTIVES:

1. 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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study Using Surgical Resection and Intraoperative Cesium-131 Permanent Interstitial Brachytherapy Implant in Resectable Recurrent Head and Neck Cancer
• Actual Study Start Date: Mar 17, 2015
• Anticipated Primary Completion Date: Jul 1, 2021
• Anticipated Study Completion Date: Jul 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Disease free survival (DFS) [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 [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 Outcome Measures

1. Recurrence rate [Up to 24 months]

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

2. Overall survival [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 [Up to 24 months]

   Estimated by cohort along with exact 95% confidence intervals

4. Adverse event rate [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University

Investigators

• Principal Investigator: Adam Luginbuhl, MD, Thomas Jefferson University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
• ClinicalTrials.gov Identifier: NCT02467738
• Other Study ID Numbers: 15D.067; 2014-112
• First Posted: Jun 10, 2015
• Last Update Posted: Dec 9, 2020
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Head and Neck Neoplasms

Study Results

No Results Posted as of Dec 9, 2020