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NCT07513389 · ClinicalTrials.gov registry record · Phase 2
Omission of Postoperative Radiation in HPV-Associated Oropharyngeal Cancer Using ctHPVDNA Surveillance (OPERATION)
A Phase 2 study, sponsored by Medical University of South Carolina.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT07513389: Recruiting Phase 2 study, sponsored by Medical University of South Carolina.
NCT07513389 is a Phase 2 study that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07513389, a Phase 2 study, is actively recruiting participants, sponsored by Medical University of South Carolina.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Proportion of participants without local or regional recurrence above the clavicles at 2 years following definitive surgery, including participants who recur but are successfully salvaged with radiation or chemotherapy during the 2-year postoperative period.
Interventions
- OTHER Active Surveillance With ctHPVDNA (NavDx®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2026-10-01 |
| Est. Completion | 2030-07-01 |
| Phase | Phase 2 |
What NCT07513389 shows while recruiting
NCT07513389 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Active Surveillance With ctHPVDNA (NavDx®) is the first listed.
NCT07513389 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07513389 about?
NCT07513389 is a clinical study titled "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 adj...
What is the current status of trial NCT07513389?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2026-10-01. Estimated completion is 2030-07-01.
What interventions are being tested in trial NCT07513389?
The interventions under investigation include: Active Surveillance With ctHPVDNA (NavDx®) (OTHER).
Who is sponsoring clinical trial NCT07513389?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07513389's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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