Personalized, Adaptive Treatment for Locally Advanced Head and Neck Cancer
ConditionHPV-Negative Squamous Cell Carcinoma
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Paclitaxel
DrugGiven as part of induction chemotherapy.
Carboplatin
DrugGiven as part of induction chemotherapy.
Cetuximab
DrugGiven as part of induction chemotherapy.
Standard Dose Radiation
RadiationRadiation given once daily for 5 days for 7 weeks as part of CRT regimen.
Low Dose Radiation
RadiationRadiation given once daily for 5 days for 6.5 weeks as part of CRT regimen.
Cisplatin
DrugGiven as part of CRT regimen (7 weekly doses). Investigator will choose the appropriate chemotherapy backbone to be given during CRT.
TFHX Regimen
DrugChemotherapy with paclitaxel, fluorouracil (5FU), and hydroxyurea given in combination with radiation therapy. Investigator will choose the appropriate chemotherapy backbone to be given during CRT.
Treatment groups
36 Participants
are divided into 3 treatment groupsGroup A: Induction Treatment ArmOther 3 interventions
Group B: De-Escalation CRT CohortExperimental treatment 3 interventions
Group C: Standard Treatment CohortActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
Percentage of participants that complete study treatment and provide all required research blood draws.
Time frame
To be measured at end of treatment period (9 weeks)2
Determine if ctDNA levels is predicative of disease response
Researchers will look at amount of ctDNA in the blood to determine if it correlates to disease response based on imaging results per RECIST v1.1.
Time frame
To be measured at end of treatment period (9 weeks)Secondary outcomes
1
Number of participants with side effects related to study treatment
Time frame
To be measured at 3 months after end of treatment period2
Long Term Disease Response based on RECIST 1.1
Time frame
To be assessed at 2 years after end of treatment periodSponsors and contacts
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Source ClinicalTrials.gov