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Recruiting Phase 1 NCT06005324

Personalized, Adaptive Treatment for Locally Advanced Head and Neck Cancer

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Plain-language summary for patients

Trial Parameters

Condition HPV-Negative Squamous Cell Carcinoma
Sponsor University of Chicago
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 36
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-12-18
Completion 2026-06
Interventions
PaclitaxelCarboplatinCetuximab

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Brief Summary

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

Inclusion Criteria: * 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. * Patients must be at least 18 years of age. * Measurable disease (either primary site and/or nodal disease) by RECIST 1.1 criteria. * No previous radiation or chemotherapy for a head and neck cancer. * No complete surgical resection for a head and neck cancer within 8 weeks of enrollment (although lymph node biopsy including excision of an individual node with presence of re

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