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