Actively Recruiting
Omission of Immediate Postoperative Radiation in Patients With Intermediate Pathological Risk Features and Negative Two-Week Post-Operative ctHPVDNA (OPERATION Trial)
Led by Medical University of South Carolina · Updated on 2026-05-20
36
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether skipping postoperative radiation therapy is safe and effective for patients with HPV-associated oropharyngeal squamous cell carcinoma (HPV-OPSCC) who have undergone transoral robotic surgery (TORS). This Phase II trial focuses on patients with low or intermediate risk pathology who test negative for circulating tumor HPV DNA (ctHPVDNA) two weeks after surgery. The goal is to determine if close monitoring without radiation can maintain cancer control while reducing treatment side effects. Participants undergo TORS, and if their ctHPVDNA test is negative postoperatively, they do not receive additional radiation. Instead, they are closely observed with regular clinical check-ups and repeated ctHPVDNA blood tests using the NavDx® technology to detect any early signs of recurrence. This ongoing monitoring aims to enable prompt treatment if the cancer returns. During the study, patients will have standard clinical surveillance combined with serial ctHPVDNA testing for up to five years. Researchers will evaluate outcomes including local-regional cancer control, progression-free survival, distant metastasis-free survival, overall survival, and swallowing function over two years. The study also tracks swallowing-related symptoms and the timing from ctHPVDNA positivity to clinical detection of recurrence. Participation requires regular follow-up visits and adherence to the monitoring schedule.
CONDITIONS
Brief Title
Omission of Postoperative Radiation in HPV-Associated Oropharyngeal Cancer Using ctHPVDNA Surveillance (OPERATION)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent is provided.
- Willingness to comply with all study procedures and availability for study duration.
- Male or female, 18 years of age or older.
- Biopsy-proven squamous cell carcinoma.
- p16 positive tumor with diffuse expression (≥70%) and moderate or higher staining intensity.
- Positive NavDx HPV16 TTMV test.
- AJCC 8th edition staging cT0-2 N1 M0.
- Well lateralized tonsil or base of tongue tumor (>1 cm from midline).
- ≤2 lymph nodes each ≤3 cm, or 1 lymph node >3 but <6 cm.
- ≤10 pack-years smoking history or no smoking for at least 5 years.
- Suitable for transoral robotic surgery (TORS) per surgeon's assessment.
- No hematogenous metastasis confirmed by imaging within 12 weeks prior to surgery.
- ECOG Performance Status 0-1.
- Adequate bone marrow, renal, and hepatic function within 8 weeks prior to surgery.
- Negative pregnancy test for women of childbearing potential within 2 weeks prior to surgery.
- Eligible for platinum chemotherapy as per physician decision.
- For females of reproductive potential, use of effective contraception during study and for 1 year after surgery.
You will not qualify if you...
- Prior head and neck surgery that may affect pathology prognostic significance.
- Prior radiation therapy to head and neck except limited skin cancer treatment.
- Cancer history within 5 years except certain early-stage skin, prostate, or thyroid cancers without metastasis.
- Prior mucosal head or neck squamous cell carcinoma treated with surgery alone.
- Current use of immunosuppressive or disease modifying rheumatoid drugs.
- Current smoker or tobacco user.
- Severe active co-morbidities including recent heart failure, myocardial infarction, infections, respiratory illness requiring hospitalization, liver failure, active autoimmune diseases, or psoriatic arthritis.
- Known HIV positive status.
- Unwillingness or inability to use contraception during and after study if of childbearing potential.
- Pregnant, breastfeeding, or planning pregnancy during study period.
- Prisoners or involuntarily incarcerated individuals.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years post-surgery
Participants undergo surgery followed by active surveillance without postoperative radiation using routine clinical follow-up and serial ctHPVDNA testing to detect recurrence.
Routine clinical visits with serial ctHPVDNA testing as per clinical schedule
Duration - Up to 5 years post-surgery
Participants are monitored with serial ctHPVDNA testing and clinical assessments to detect recurrence and evaluate long-term outcomes.
Periodic follow-up visits with ctHPVDNA testing
Trial Site Locations
Total: 1 location
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
H
HCC Clinical Trials Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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