Intraoperative Placement of Cesium-131 Permanent Interstitial Brachytherapy in Head and Neck Cancer

December 21, 2020 updated by: Case Comprehensive Cancer Center

A Pilot Study Using Intraoperative Placement of Cesium-131 Permanent Interstitial Brachytherapy in Resectable High Risk Recurrent Head and Neck Cancer

The purpose of this study is to explore the use of a treatment called interstitial brachytherapy for patients who have a high risk resectable (able to be treated with surgery) recurrent head and neck cancer.

Brachytherapy is a form of radiation therapy that uses radioactive seeds and implants them into a specific place on your body. This study is using Cesium-131 permanent interstitial brachytherapy.

Cesium-131 is FDA approve for brachytherapy use, however, there are currently no research studies to show how effective it is for head and neck cancer. The goal of this study is determine the effect that the placement of Cesium-131 brachytherapy seeds has on overall survival as well as to assess possible side effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary Objective:

To assess the effect of Cesium 131 brachytherapy in subjects with resectable recurrent cancer of the head and neck by evaluating disease free survival (DFS) and comparing to a previous cohort. Potential effects on locoregional control rate and overall survival will be explored.

Secondary Objective:

To assess toxicity associated with cesium 131 brachytherapy treatment.

Study Design Patients with a head and neck recurrent cancer who are planned to undergo definitive tumor resection surgery that meet our inclusion and exclusion criteria will be offered participation in this clinical trial.

Participant's Follow-up. The participant's medical records will be reviewed every 3 months for 24 months to assess: loco-regional control, distant metastasis free survival, disease free survival, and overall survival. This will allow us to assess the potential treatment effect of cesium 131.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must have histologically or cytologically confirmed recurrent head and neck cancer.
  • Based on clinical and radiographic evidence the tumor needs to be deemed resectable preoperatively by the surgeon and when necessary (determined by the surgeon) tumor board review.
  • Patients must have potentially curable disease
  • Karnofsky Performance status ≥ 60% (ECOG/Zubrod 0,1,or 2)

  • Subjects must have normal organ and marrow function as defined below:

    • Hemoglobin ≥ 7.0 g/dl
    • Absolute neutrophil count (ANC) > 500/mcL
    • Platelet count ≥ 75,000/mcL
  • Patients with recurrent/previous treated head and neck squamous cell carcinoma that is deemed surgically resectable by the treating physician but at high risk for recurrence due to concerns regarding close and/or margins due to locations on or near critical structures such as internal or common carotid, skull base, deep cervical musculature, and other areas that may limit the possibility of an enbloc resection. This group otherwise would be considered for retreatment with radiation and/or chemoradiation.
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients deemed to have un-resectable disease by the treating surgeon or upon tumor board review.

    • Patients with exposed carotid artery preoperatively requiring sacrifice or bypass intra-operatively
    • Patients with active pharyngocutaneous fistula

    • Patients may have had a recent previous hospital admission (within 30 days) or be admitted preoperatively but not for the following conditions

      • Unstable angina
      • Congestive heart failure

      • Severe hypothyroidism TSH >10

        ---- Endocrine consult and intervention may allow participation at the discretion of the principal investigator for a thyroid-stimulating hormone (TSH) > 10.

      • Patients deemed to be "High Risk" by pre admission testing (CPM) or by a preoperative risk assessment by the hospitalist for perioperative complications
      • Subjects with more than one site of distant metastatic disease (beyond the head and neck) as evidenced by computerized tomography (CT) scan or positron emission tomography/CT (PET/CT) or biopsy ---- A subject with a single lung nodule (deemed cancerous by PET/CT or Biopsy) will not be excluded.
  • Subjects receiving any other investigational agents.
  • Subjects with untreated brain metastases/central nervous system disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cesium 131 or other agents used in this study.
  • Pregnant or breastfeeding women are excluded from this study because Cesium 131 has the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with Cesium 131, breastfeeding should be discontinued if the mother is treated with Cesium 131. These potential risks may also apply to other agents used in this study.
  • Subjects who are HIV-positive will be excluded from the study. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Cesium 131. In addition, these subjects are at increased risk of lethal infections when treated with marrow suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cesium 131 brachytherapy
Cesium 131 is the radioactive isotope in the protocol. The prescribed dose will range from 50-80 Gy at maximal delivery. It comes in 0.5 cm seeds that will be placed in the tumor resection bed at 1cm intervals. They are implantable seeds that do not require removal.
Drug: Cesium 131
The number sources and activity will be based on the target volume to deliver total radiation dose, this will vary per patient.
Other Names:
  • Cs-131
  • Cesium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median disease free survival (DFS)
Time Frame: Up to two years
DFS defined as the time of diagnosis with no evidence of disease through death by any cause or relapse of disease.
Up to two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Investigators

  • Principal Investigator: Min Yao, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 21, 2016

Primary Completion (ACTUAL)

July 24, 2020

Study Completion (ACTUAL)

July 24, 2020

Study Registration Dates

First Submitted

June 6, 2016

First Submitted That Met QC Criteria

June 6, 2016

First Posted (ESTIMATE)

June 9, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 23, 2020

Last Update Submitted That Met QC Criteria

December 21, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE5315
  • NCI-2017-00023 (REGISTRY: NCI CTRP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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