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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794675
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Head and Neck Squamous Cell Carcinoma Drug: Cesium 131 Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Using Intraoperative Placement of Cesium-131 Permanent Interstitial Brachytherapy in Resectable High Risk Recurrent Head and Neck Cancer
Actual Study Start Date : December 21, 2016
Actual Primary Completion Date : January 27, 2019
Actual Study Completion Date : January 27, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794675


Locations
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United States, Ohio
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Chad Zender, MD, FACS University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02794675     History of Changes
Other Study ID Numbers: CASE5315
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019

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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
Keywords provided by Case Comprehensive Cancer Center:
resectable
Cesium 131
brachytherapy
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site