Personalized, Adaptive Treatment for Locally Advanced Head and Neck Cancer

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago

About this trial

This clinical trial will assess whether or not blood based biomarker testing can be used to personalize cancer treatment for patients with locally advanced head and neck cancer.

Eligibility criteria

Qualifiers

Patients must have pathologically confirmed locally advanced, non-metastatic, human papillomavirus (HPV) negative head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, nasopharynx, larynx, or sinuses.

Stage III or IV disease based on American Joint Committee on Cancer (AJCC) staging 8th edition.

If a primary oropharyngeal squamous cell carcinoma is diagnosed, HPV must be ruled out by immunohistochemistry.

Availability of ≥10 unstained 5 micron slides. Patients who cannot fulfill this requirement will need to undergo a new biopsy prior to enrollment on study.

Disqualifiers

Unequivocal demonstration of distant metastatic disease (M1 disease).

Unidentifiable primary site.

Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival. This includes but is not limited to ongoing or active infection, immunodeficiency, symptomatic congestive heart failure, pulmonary dysfunction, cardiomyopathy, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance. Patients with clinically stable and/or chronically managed medical illnesses that are not symptomatic and/or are not expected to impact treatment on protocol are still eligible (conditions to be reviewed by the PI to confirm eligibility).

Prior surgical therapy other than incisional/excisional biopsy or organ-sparing procedures such as debulking of airway-compromising tumors. Residual measurable tumor is required for enrollment as discussed above.

Trial design

Treatments tested in this trial

  • Paclitaxel
  • Carboplatin
  • Cetuximab
  • Standard Dose Radiation
  • Low Dose Radiation
  • Cisplatin
  • TFHX Regimen

Treatment groups

36 Participants
are divided into 3 treatment groups

Sponsors and collaborators