At a glance
ClinicalIndex Comparison Record- ✓Pathologically proven squamous cell carcinoma of oropharynx (tonsil, base of tongue, soft palate, posterior wall)
- ✓p16 positive by immunohistochemistry (>70% staining) if primary site biopsied
- ✓Detectable HPV ctDNA at screening or baseline (Naveris test)
- ✓Clinical stage T1-T3, N1-N2b (AJCC 7th Edition) with no distant metastases
- ✕Undetectable baseline plasma HPV DNA level
- ✕Cancers from oral cavity, nasopharynx, hypopharynx, or larynx sites
- ✕Carcinoma of neck from unknown primary site
- ✕Distant metastasis or adenopathy below clavicles
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Adaptive De-escalation of Radiation Therapy Dose in HPV-Positive Oropharyngeal Carcinoma (ART) Demonstrating Favorable Mid-Treatment Response
In Brief
A Phase 2 clinical trial evaluating Standard Radiation Treatment, Dose-Deescalated Treatment, and 1 other intervention for Oropharyngeal Carcinoma and HPV Positive Oropharyngeal Squamous Cell Carcinoma. Currently recruiting, targeting 120 participants across 1 site.
Detailed Summary
This is a phase II clinical trial. The purpose of this study is to determine the feasibility of deescalating chemoradiation treatment based on mid-treatment tumor response determined by rapid nodal shrinkage and clearance of circulating HPV plasma tumor DNA . The primary objective of this study is to evaluate progression-free survival at 2 years.
Study Details
Timeline
Interventions
An interval scan at 4 weeks to assess for a good response defined as \>40% nodal shrinkage will stratify patients into receiving standard treatment (≤40% nodal shrinkage) or a dose-deescalated treatment regimen (\>40% nodal shrinkage). Those with nodal shrinkage and clearance of circulating plasma HPV DNA shall undergo further treatment de-escalation.
Intensity-modulated radiation therapy (IMRT) is an advanced type of radiation therapy used to treat cancer and noncancerous tumors. IMRT uses advanced technology to manipulate photon and proton beams of radiation to conform to the shape of a tumor. Patients will be treated with intensity-modulated radiation therapy (IMRT) with megavoltage photons
Standard of care chemotherapy