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Reduced Radiation and Chemotherapy for HPV-Positive Throat Cancer

This study is looking at whether a lower dose of radiation therapy, combined with standard chemotherapy, can reduce side effects for people with HPV-positive throat cancer (oropharyngeal cancer). The chemotherapy drugs used are cisplatin, carboplatin, and 5-fluorouracil (5-FU). Researchers want to see if this approach can prevent the cancer from returning in the treated area. You may be able to join if you are 18 or older and have HPV-associated squamous cell carcinoma of the oropharynx. The study plans to enroll 121 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 121 participants. It is testing a reduced radiation dose alongside standard chemotherapy.
What's involved
You will receive an 18F-FMISO PET/CT scan, radiation therapy over 3 weeks, and two cycles of chemotherapy with cisplatin, or carboplatin and 5-fluorouracil.
Compensation
Not stated in the trial record.
Follow-up
Researchers will check for cancer recurrence in the treated area for 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.

NCT05491512

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~121 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:18 F-FMISO PET/CTRadiationCisplatinCarboplatin5-fluorouracil

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with any locoregional recurrences
Measured over 2 years

Conditions

HPV
Throat Cancer
Oropharyngeal Carcinoma
Oropharyngeal Cancer
Human Papilloma Virus

Explore related trials

Oropharyngeal CarcinomaHPV

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.
Oropharyngeal Carcinoma (AJCC, 7th ed.) without evidence of distant metastasis based on FDG PET/CT.
CT 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 ≥ 50
Age ≥ 18 Patients over 70yrs will be able to enroll in Cohort B only).
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:
Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
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
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

  • Number of participants with any locoregional recurrences2 years

    The primary objective of this protocol is to demonstrate that the 2 year locoregional control for these subjects treated with a major de-escalated radiation dose of 30Gy is acceptable as compared to historical locoregional control rate for subjects treated with the current standard chemoradiation at 70Gy. To examine if subjects receiving 30Gy have an acceptable treatment outcome when compared to the radiation of 70Gy both in the setting of concurrent chemotherapy, we will test the hypothesis that H0: P\<=85% vs H1: P\>85%, where P represents the 2-year locoregional control rate.