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

Primary Purpose

Recurrent Head and Neck Carcinoma

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Brachytherapy
Cesium-131
Conventional surgery
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Head and Neck Carcinoma

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cesium-131 Brachytherapy

Arm Description

Patients undergo brachytherapy using Cesium-131 during surgical resection

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Recurrence rate
Comparisons of 6-month and one-year recurrence rates will be performed using logistic regression
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.
Complication rate
Estimated by cohort along with exact 95% confidence intervals
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

Full Information

First Posted
June 5, 2015
Last Updated
July 24, 2023
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT02467738
Brief Title
Surgical Resection and Intraoperative Cesium-131 Brachytherapy for Head and Neck Cancer
Official Title
A Pilot Study Using Surgical Resection and Intraoperative Cesium-131 Permanent Interstitial Brachytherapy Implant in Resectable Recurrent Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 17, 2015 (Actual)
Primary Completion Date
August 3, 2018 (Actual)
Study Completion Date
May 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Head and Neck Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cesium-131 Brachytherapy
Arm Type
Experimental
Arm Description
Patients undergo brachytherapy using Cesium-131 during surgical resection
Intervention Type
Radiation
Intervention Name(s)
Brachytherapy
Intervention Description
Undergo brachytherapy with Cesium-131
Intervention Type
Drug
Intervention Name(s)
Cesium-131
Intervention Description
Undergo brachytherapy with Cesium-131
Intervention Type
Procedure
Intervention Name(s)
Conventional surgery
Intervention Description
Undergo surgical resection
Primary Outcome Measure Information:
Title
Disease free survival (DFS)
Description
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
Time Frame
Up to 24 months
Title
Incidence of toxicity
Description
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.
Time Frame
Up to 90 days
Secondary Outcome Measure Information:
Title
Recurrence rate
Description
Comparisons of 6-month and one-year recurrence rates will be performed using logistic regression
Time Frame
Up to 24 months
Title
Overall survival
Description
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.
Time Frame
Up to 24 months
Title
Complication rate
Description
Estimated by cohort along with exact 95% confidence intervals
Time Frame
Up to 24 months
Title
Adverse event rate
Description
Evaluated using the National Cancer Institute, Common Terminology Criteria for Adverse Events version 4.0 Estimated by cohort along with exact 95% confidence intervals
Time Frame
Up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Luginbuhl, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34900741
Citation
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.
Results Reference
derived
Links:
URL
http://hospitals.jefferson.edu/
Description
Jefferson University Hospitals

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

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