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

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT07513389
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Active Surveillance With ctHPVDNA (NavDx®) — OTHER
    Active surveillance without postoperative radiation using routine clinical follow-up and serial ctHPVDNA testing to detect recurrence.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Jul 1, 2029
Completion
Jul 1, 2030

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Active Surveillance With ctHPVDNA After Surgery
    Participants with negative postoperative ctHPVDNA are observed without adjuvant radiation and followed with routine clinical surveillance and serial ctHPVDNA testing.

Primary Outcome Measure

Local-Regional Control [ Time Frame: 2 years post-surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
HCC Clinical Trials Office
[email protected]
843-792-9321

Find similar trials in Charleston, SC

By condition
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By specialty
OncologySkin cancerDermatology
By research site
Medical University of South Carolina· Charleston, SC

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