Omission of Postoperative Radiation in HPV-Associated Oropharyngeal Cancer Using ctHPVDNA Surveillance (OPERATION)

This single-arm Phase II trial evaluates whether omission of postoperative radiotherapy is feasible and oncologically safe in select patients with HPV-associated oropharyngeal squamous cell carcinoma (HPV-OPSCC). Eligible patients undergo transoral robotic surgery (TORS) and are observed without adjuvant radiation if they demonstrate low or intermediate pathological risk features and have negative circulating tumor HPV DNA (ctHPVDNA) two weeks post-operatively. Patients are followed with standard clinical surveillance combined with serial ctHPVDNA testing (NavDx®) to facilitate early detection

Trial Details

NCT ID
NCT07513389
Phase
PHASE2
Sponsor
Medical University of South Carolina
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • Active Surveillance With ctHPVDNA (NavDx®)
Locations (sample)
  • Charleston, South Carolina, United States|32.77632,-79.93275

Key Eligibility Criteria

  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Male or female, ≥ 18 years of age (no upper age limit).
  • Biopsy proven squamous cell carcinoma.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Head and Neck Cancer Trials on Trialify →