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Adaptive Treatment De-escalation for HPV-Positive Oropharyngeal Carcinoma

This study is looking at a new way to treat HPV-positive oropharyngeal (throat) cancer. It's a Phase 2 trial that aims to see if we can reduce the amount of radiation treatment for some patients. You might receive either standard radiation treatment or a lower dose of radiation (Dose-Deescalated Treatment) if your tumor shrinks significantly after 4 weeks. All patients will also receive Cisplatinum, a standard chemotherapy drug. We want to see how many patients are free from cancer progression after 2 years. To join, you must have squamous cell carcinoma of the oropharynx, be at least 18 years old, and of any gender. The study status is currently unclear.

Study design
This is a Phase 2 interventional study planning to enroll 120 participants. Treatment will be adjusted based on how well your tumor responds after 4 weeks.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your progression-free survival will be measured at 2 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03215719

Adaptive Treatment De-escalation in Favorable Risk HPV-Positive Oropharyngeal Carcinoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
NYU Langone Health
~120 participants
Updated 2026-01-06 on ClinicalTrials.gov
What's tested:Standard Radiation TreatmentDose-Deescalated TreatmentCisplatinum

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival at 2 years
Measured over 2 Years

Conditions

Oropharyngeal Carcinoma
HPV Positive Oropharyngeal Squamous Cell Carcinoma

Explore related trials

Oropharyngeal CarcinomaCDKN2A wt AlleleHPV

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Kenneth Hu, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Kenneth Hu
[email protected]
212-731-5003
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the oropharynx, which include the sites tonsil, base of tongue, soft palate, or posterior oropharyngeal wall. Histologic variants will be included (papillary squamous cell carcinoma and basaloid squamous cell carcinoma). Cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx.
If the primary site is biopsied, Patient's tissue must be positive for p16 by immunohistochemical staining (\>70% staining). Fine needle aspiration (FNA) biopsy specimens may be used as the sole diagnostic tissue if formalin-fixed paraffin-embedded cell block material is not available for p16 immunohistochemistry.
Patients must have detectable HPV ctDNA Score Report at Screening or have a detectable baseline HPV ctDNA Score Report (Naveris test) if no primary site is biopsied. Must have detectable screening plasma HPV DNA (also referred to as ctHPV DNA).
Clinical stage T1-T3, N1-N2b (AJCC 7th Edition) with no distant metastases based on the following diagnostic workup:
Fiberoptic exam with laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within 8 weeks prior to registration.
One of the following combinations of imaging is required within 8 weeks of registration:
Patients must provide their personal smoking history prior to registration. Patients cannot have a cumulative personal smoking history that exceeds 10 pack-years.
Zubrod Performance Status of 0-1 within 8 weeks prior to registration;
Adequate hematologic function within 2 weeks prior to registration, defined as follows:
Adequate renal function within 2 weeks prior to registration, defined as follows:
Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential;
Patients who are HIV positive but who have no prior AIDS-defining illness and have CD4 cells of at least 350/mm3 are eligible. HIV-positive patients must not have multi-drug resistant HIV infection or other concurrent AIDS-defining conditions. Patients must not be sero-positive for Hepatitis B (Hepatitis B surface antigen positive or anti-hepatitis B core antigen positive) or sero-positive for Hepatitis C (anti-Hepatitis C antibody positive). However, patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B).
The patient must provide study-specific informed consent prior to study entry.

Exclusion

Missing or undetectable baseline plasma HPV DNA level
Cancers considered to be from an oral cavity site (oral tongue, floor of mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive;
Carcinoma of the neck of unknown primary site origin (even if p16 positive);
Distant metastasis or adenopathy below the clavicles;
Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease.
Simultaneous primary cancers or separate bilateral primary tumor sites;
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible);
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
Severe, active co-morbidity defined as follows:
Pregnancy; this exclusion is necessary because the treatment in this study may be significantly teratogenic
Prior allergic reaction to cisplatin.
Electrical implants such as cardiac pacemakers or perfusion pumps
Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants
Ferromagnetic objects such as jewelry or metal clips in clothing
Claustrophobia
History of seizures
Patients with GFR \< 15 ml/min/1.73m2 or who are on dialysis will not have DCE-MRI scan. These patients will have conventional anatomical MRI without contrast.

What this trial measures

  • Progression-free survival at 2 years2 Years

    The non-inferiority (NI) analysis will be conducted on the pooled de-escalated cohort (Arms 3+4 combined) to evaluate whether the 2-year PFS is acceptable relative to the historical benchmark. For Arm 3 and Arm 4 separately, Kaplan-Meier curves and 2-year PFS estimates with 95% confidence intervals will be provided. Patients who do not experience progression of disease and have not died will be censored on the date of last follow up.