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Personalized vs. Standard Radiation for HPV-Positive Throat Cancer

This study is comparing two ways to treat HPV-positive throat cancer (HPV-Related Squamous Cell Carcinoma): a personalized radiation therapy that might use a lower dose, and the standard radiation therapy. Both approaches combine radiation with standard chemotherapy (cisplatin, carboplatin, and 5-FU). Researchers want to see if the personalized approach is just as effective and causes fewer side effects, while also looking at how treatments affect your quality of life. You may be able to join if you are 18 or older and have a confirmed diagnosis of HPV-associated throat cancer. The main goal is to see how long people live after two years. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 291 participants. It compares two different approaches to chemoradiation therapy.
What's involved
You would undergo an 18F-FMISO scan (a diagnostic test) around week two of radiation treatment. You would also complete three questionnaires about your quality of life.
Compensation
Not stated in the trial record.
Follow-up
Your overall 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.

NCT06563479

A Study Comparing Personalized Radiation Therapy With Standard Radiation Therapy in People With HPV-Positive Throat Cancer

Recruiting
PHASE3Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~291 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:FMISO-PET ScanChemoradiationAssessments

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
overall survival
Measured over 2 years

Conditions

HPV-Related Squamous Cell Carcinoma

Explore related trials

Oropharyngeal Squamous Cell CarcinomaCDKN2A wt AlleleHPV

Where it's being run

9 sites across 4 states
New York4
New Jersey3
Connecticut1
Florida1

Study leadership

  • Nancy Lee, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Nancy Lee, MD
[email protected]
212-639-3341
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 HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls) or squamous cell carcinoma with an unknown primary. Surgical removal of primary site is allowed.
Patients must test positive for both p16 expression (70% nuclear and cytoplasm expression; Ventana Medical Systems) and mRNA HPV in situ hybridization (RNAscope® 2.5 HD Reagent kit (Advanced Cell Diagnostics, Inc, Hayward, CA). Any CLIA certified testing method can be used.
Clinical stage Tx-2, N1-2c (AJCC, 7th ed.) without evidence of distant metastasis based on FDG PET/CT.
ECOG Performance Status of 0-1 or KPS \>/=70
Age ≥ 18
Adequate hematologic function within 30 days prior to registration, defined as follows:
White Blood Count (WBC) ≥ 2 K/mcL
Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
Platelets ≥ 100,000 cells/mm\^3
Hemoglobin ≥ 10.0 g/dl
Adequate renal function within 30 days prior to registration, defined as follows:
Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
The patient must provide study-specific informed consent prior to study entry
Optional section of the protocol: Patients must be able to undergo MRI scans, i.e. not claustrophobic

Exclusion

Patients with prior head and neck radiation therapy where there is \>30% overlap with the current head and neck radiation fields. Exceptions can be made if determined by the PI/Co-PI that the patient can proceed with protocol activities
Patients whose tumors are borderline T4 based on anterior tumor extension to the extrinsic muscles of the tongue
Patients with simultaneous primary cancers outside of the oropharynx
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years to be 90% or greater
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
No particle therapy
Patients who are deemed non-compliant to all the protocol related activities
Contraindications to receive either cisplatin or the combination of carboplatin/5-fluorouracil at the prescribed doses.
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 registration
Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
Hepatic Insufficiency resulting in clinical jaundice and/or coagulation defects

What this trial measures

  • overall survival2 years

    The measurement of survival will be evaluated as a time from randomization to events endpoint (i.e., death due to any cause) so that censored data are allowed. To assess the overall survival rate, Kaplan-Meier estimates will be calculated and reported.