Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07513389 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 3 months later Jul 1, 2029 → Oct 31, 2031
See other at-risk trials from Medical University of South Carolina

Record History

  1. Primary completion pushed from Jul 1, 2029 to Oct 31, 2031 Completion pushed from Jul 1, 2030 to Jul 1, 2034 · Start date changed from estimate of Oct 1, 2026 to Aug 12, 2026v4 Show 2 more changesShow less
    • Completion pushed from Jul 1, 2030 to Jul 1, 2034
    • Start date changed from estimate of Oct 1, 2026 to Aug 12, 2026
  2. Start date: Jul 1, 2026 to Oct 1, 2026v3
  3. Recruitment opened Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 of recurrence and prompt salvage therapy as needed.
Trial Details
NCT Number NCT07513389
Lead Sponsor Medical University of South Carolina
Conditions Squamous Cell Carcinoma, Human Papilloma Virus (HPV), Oropharyngeal Squamous Cell Carcinoma (OPSCC)
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov