Risk Adapted De-Intensification of Radio-Chemotherapy for Oropharyngeal Squamous Cell Carcinoma

This study builds on the results of several prior studies that we have been involved with to test the hypothesis that Risk-Adapted De-Intensification of Radiation Therapy and chemotherapy based on HPV subtype, plasma circulating free HPV DNA (cfHPV DNA) level, and cfHPV DNA clearance rate produces Local-Regional Control rates that are similar to what has been achieved with more aggressive therapy in patients with Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma (OPSCC).

Trial Details

NCT ID
NCT05268614
Phase
PHASE2
Sponsor
University of Florida
Status
RECRUITING
Cancer Type
HPV Positive Head and Neck Cancer
Interventions
  • Radiation therapy
  • Cisplatin
Locations (sample)
  • Gainesville, Florida, United States|29.65163,-82.32483
  • Jacksonville, Florida, United States|30.33218,-81.65565
  • Charleston, South Carolina, United States|32.77632,-79.93275

Key Eligibility Criteria

  • ≥ 18 years of age (no upper age limit)
  • T0-3, N0 to N2, M0 squamous cell carcinoma of the oropharynx by AJCC 8th Edition staging. If T0 the adenopathy must be predominantly in Level 2.
  • Tissue diagnosis of HPV and/or p16 positivity from the primary site or an associated lymph node.
  • Radiologic confirmation of the absence of lung metastasis within 12 weeks prior to treatment; at a minimum, CT of the chest is required. PET-CT is …

For full eligibility, visit ClinicalTrials.gov.

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