A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)

Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have very good outcomes. Patients' treatment responses depend more on their individual cancer characteristics and personal risk factors than on the specific type of treatment they receive. However, the different treatments used for this cancer can cause significant side effects. Because outcomes are often favorable regardless of treatment type, reducing treatment-related side effects should be a priority when choosing care. Studies have reported that lowering radiation doses for some patients can reduce side effec

Trial Details

NCT ID
NCT07418034
Phase
PHASE2
Sponsor
University of Maryland, Baltimore
Status
RECRUITING
Cancer Type
HPV Positive Head and Neck Cancer
Interventions
  • Dose de-escalation to contralateral neck.
  • Dose de-escalation to gross disease to contralateral neck
  • Dose de-escalation to gross disease
  • Circulating Tumor DNA test (ctDNA test)
Locations (sample)
  • Baltimore, Maryland, United States|39.29038,-76.61219
  • Baltimore, Maryland, United States|39.29038,-76.61219
  • Columbia, Maryland, United States|39.24038,-76.83942
  • Glen Burnie, Maryland, United States|39.16261,-76.62469

Key Eligibility Criteria

  • (Y) 1. Is there pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants p…
  • (Y) 2. Is the patient ≥ 18 years of age?
  • (Y) 3. Did the patient provide study specific informed consent prior to study entry, including consent for mandatory submission of tissue for requi…
  • (Y) 4. Clinical TNM staging criteria by cohort (AJCC 8th edition):

For full eligibility, visit ClinicalTrials.gov.

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