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Reduced Radiation Therapy for HPV-Positive Throat Cancer

This study is looking at whether a lower dose of radiation therapy, combined with standard chemotherapy, is as effective as standard radiation doses for people with HPV-positive throat cancer (oropharyngeal carcinoma). The chemotherapy drugs used in this study include carboplatin, paclitaxel, and cetuximab, followed by carboplatin, cisplatin, or 5-fluorouracil (5-FU) with radiation. You may be eligible if you have HPV-associated squamous cell carcinoma of the oropharynx. Researchers will measure how well the treatment controls the cancer in the treated area (locoregional control) after two years. The current status of this study is unclear, and it plans to enroll 74 participants.

Study design
This is an interventional study with a planned enrollment of 74 participants. The phase of the study is not specified.
What's involved
You would receive an 18F-FMISO PET/CT scan during chemoradiation. You would also complete questionnaires like EQ-5D-5L, MDADI-HN, and COST-FACIT.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, locoregional control, will be measured at 2 years.

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NCT06984861

A Study of Reduced Radiation Therapy With Chemotherapy in People With HPV-Positive Throat Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~74 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:18F-FMISO PET/CT ScanChemoradiationQuestionnaires

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Locoregional control
Measured over 2 years

Conditions

Oropharyngeal Carcinoma

Explore related trials

Oropharyngeal CarcinomaCDKN2A wt AlleleHPV

Where it's being run

7 sites across 2 states
New York4
New Jersey3

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) from biopsy, surgical resection or excisional biopsy regardless of margin status.
Subjects must have clinically or radiographically evident measurable gross disease at either the primary tumor site or nodal stations.
T3-4/N0-2c or any N3 regardless of Tstage (AJCC 7th Edition) HPV+ OPC\* or HPV associated squamous cell carcinoma with nodal metastasis (es) but unknown primary sites without evidence of distant metastasis based on FDG PET/CT.
CT Neck with contrast or MRI of the neck with and without contrast Note: A CT scan of neck and/or a PET/CT performed for the purposes of radiation planning may serve as planning tools.
ECOG Performance Status of 0-2 or KPS ≥ 70
Age ≥ 18
Adequate hematologic function within 30 days prior to registration, defined as follows:
Adequate renal function within 30 days prior to registration, defined as follows:
Adequate hepatic function within 30 days prior to registration, defined as follows:
One cycle of induction chemo therapy is allowed prior to registration based on clinical needs.
The subject must provide study-specific informed consent prior to study entry Subject able to undergo MRI scans except for major medical contraindications like presence of a pacemaker or approved by the PI or the CO-PI that the subject does not need to undergo MRI scans

Exclusion

Subjects with prior head and neck radiation therapy
Subjects with simultaneous primary cancers outside of the oropharynx if determined by the PI/Co-PI the patient can proceed with protocol activities.
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
Severe, active co-morbidity defined as follows (exceptions can be made if approved by the PI and/or co-PI)

What this trial measures

  • Locoregional control2 years

    Researchers will test the null hypothesis H0: P=78% vs the alternative hypothesis H1:P=91%, where P represents the 2-year locoregional control (LRC). We will use the Kaplan-Meier method to estimate the LRC rate at 2 years and construct a 0.975 1-sided confidence interval in order to achieve a test size alpha = 0.05 (this is based on a finite-sample correction using 100,000 simulations).