Using Circulating Tumor DNA to Guide Post-Surgery Therapy for HPV-Associated Oropharyngeal Cancer
This study is looking at how to best treat HPV-associated oropharyngeal cancer (a type of throat cancer) after surgery. It will test different doses of cisplatin (a chemotherapy drug) and radiation therapy based on your tumor's characteristics, including a blood test for HPV DNA. The goal is to see if this personalized approach can prevent the cancer from returning for at least two years. You might be able to join if you have p16-positive oropharyngeal squamous cell carcinoma that has been surgically removed. The study is currently unclear on its recruitment status and plans to enroll 50 participants.
- Study design
- This is a single-institution study that will enroll 50 participants. It is an interventional study, meaning participants will receive a specific treatment.
- What's involved
- You will undergo transoral robotic surgery, followed by cisplatin-based chemoradiation. Your specific treatment will depend on your post-operative cTTMV-HPV DNA results and pathology.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure how many participants are free from cancer progression at 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06445114
Using CircuLating Tumor DNA to Risk Adapt Post-Operative Therapy for HPV-associated Oropharyngeal Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentZachary ZumstegInvestigator-initiated
~50 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Cisplatin
At a glance
Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
2-year progression-free (PFS)
Measured over 2 Years
Conditions
Where it's being run
4 sites across 1 statesCalifornia4
Study leadership
- Zachary S Zumsteg, MD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
AJCC 8th edition T0-3N0-2 p16-positive oropharyngeal (tonsil, base of tongue, glossotonsillar sulcus, soft palate, oropharyngeal wall) squamous cell carcinoma or squamous cell carcinoma of unknown primary involving the cervical lymph nodes. Cytologic diagnosis from a cervical lymph node is sufficient for diagnosis in the presence of clinical evidence of a primary tumor in the oropharynx.
For patients with pT0 tumors (unknown primary), there must be at least one metastatic lymph node present in cervical level II.
p16 is strongly positive by immunohistochemistry or high-risk HPV is detected by in-situ hybridization.
Have undergone or will undergo gross total resection of all known disease in the head and neck via transoral robotic surgery. For patients with clinical unknown primary tumors, a patient must undergo both ipsilateral tonsillectomy and base of tongue resection unless the primary is identified clinically or pathologically at the time of surgery. If the primary is identified, then only resection of the primary site is required. If the primary tumor is resected with negative margins with a non-robotic surgery, such as a diagnostic tonsillectomy, this is considered acceptable and further robotic surgery is not necessary.
Have undergone or will undergo neck dissection.
Have at least one of the following after surgery:
Pathologic stage T3
2 or more positive lymph nodes
At least one lymph node \>3cm
Contralateral lymph node involvement
Lymphovascular invasion
Perineural invasion
Extranodal extension
Close/positive margins: Close margins are considered ≤3mm from the peripheral margins and ≤1mm from the deep margin on the en bloc specimen, unless the area of close margin is re-resected and without carcinoma.
Patients consented preoperatively are required to have detectable cTTMV-HPV DNA based on pre-operative NavDx testing. For patients consented post-operatively, NavDx testing should be performed on the tumor tissue to ensure detectable HPV DNA and for HPV subtyping.
Age ≥ 18 years old
ECOG performance status 0 or 2 within 56 days of start of chemoradiation.
Women of childbearing potential require a negative serum or urine pregnancy test within 28 days prior to start of chemoradiation.
Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Adequate hematologic and renal function within 56 days of start of chemoradiation, defined as:
Hemoglobin ≥ 9.0 g/dL
Platelets ≥ 100, 000 cells/mm3
ANC ≥ 1.5 X 109/L
Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
Aspartate aminotransferase/alanine aminotransferase ≤ 3.0 x upper limit of normal (ULN)
Serum creatinine ≤1.5 x upper limit of normal (ULN) OR a calculated creatinine clearance ≥50 mL/min estimated using the following Cockcroft-Gault equation
Severe, active co-morbidity, defined as follows:
Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
Transmural myocardial infarction within the last 6 months
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of enrollment
Hepatic insufficiency resulting in clinical jaundice and/or known coagulation defects
Moderate to severe hearing loss.
Active connective tissue disease (e.g. systemic lupus erythematous, scleroderma) requiring immunosuppression.
Pregnant or breast-feeding women.
Prior allergic reaction to cisplatin.
Live vaccines within 30 days prior to the first dose of chemoradiation. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral vaccine). Season influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines and are not allowed.
Exclusion
AJCC 8th edition pT4 or cN3 disease.
Radiologic or clinical evidence of distant metastasis.
Recurrent disease.
Inability to achieve gross total resection at time of surgery.
Greater than 56 days (8 weeks) after surgical resection of the primary site.
Prior radiation to the head and neck \> 30 Gy.
What this trial measures
- 2-year progression-free (PFS)2 Years
The primary objective of this study is to assess the 2-year progression-free survival (PFS) of de-intensified post-operative chemoradiation in patients with HPV-associated oropharyngeal cancer when basing treatment intensity on both standard pathologic features and post-operative Blood-based circulating tumor tissue modified viral (cTTMV-HPV DNA)