Loading clinical trials...

A Study of Reduced Radiation Therapy With Chemotherapy in People With HPV-Positive Throat Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

Major Radiation Dose De-Escalation Concurrent With Chemotherapy for Advanced Stage Human Papilloma Virus Associated Oropharyngeal Carcinoma

NCT06984861•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The researchers are doing this study is to find out if lower doses (given in fewer treatments over a shorter period of time) of radiation therapy in combination with standard-of-care chemotherapy is an effective treatment for people with Human Papilloma Virus (HPV)-positive throat cancer and works as well as the standard doses of radiation therapy in combination with standard-of-care chemotherapy. The chemotherapy drugs used in combination with radiation therapy in this study include cisplatin, carboplatin, and 5-fluorouracil (5-FU).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•1. Squamous cell carcinoma of the neck of unknown primary is allowed with excision biopsy of a lymph node (or core biopsy) or consent from the PI or co-PI. Patient must have excisional biopsy or core biopsy done in order to be on protocol.
•Note: Evidence of HPV associated oropharyngeal cancer from either the primary tumor site or from a lymph node. A patient is HPV positive when he or she tests positive having tested positive for both p16 expression (70% nuclear and cytoplasm expression; Ventana Medical Systems) and mRNA HPV in situ hybridization.
•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:
•1. White Blood Count (WBC) ≥ 2 K/mcL
+11 more criteria

Exclusion Criteria

•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.
•Note: Exceptions can be made for patients with simultaneous primaries outside 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)
•1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
•2. Transmural myocardial infarction within the last 6 months
•3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
•4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
+1 more criteria

Locations (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

Key Dates

Start Date

May 13, 2025

Primary Completion Date

May 1, 2028

Completion Date

May 1, 2028

Last Updated

March 9, 2026

Enrollment

ESTIMATED participants

Conditions

Oropharyngeal Carcinoma

Interventions

18F-FMISO PET/CT Scan

DIAGNOSTIC_TEST

Chemoradiation

COMBINATION_PRODUCT

Questionnaires

OTHER

Contacts

Nancy Lee, MD

CONTACT

212-639-3341 leen2@mskcc.org

Nadeem Riaz, MD

CONTACT

646-888-3495

Intensity Modulated Proton or X-Ray Therapy After Surgery for Treatment of Head and Neck Cancer, the HEADLIGHT Study

NCT05075980

Head and Neck CarcinomaHead and Neck Carcinoma of Unknown Primary+10 more

View study

RECRUITINGPHASE2

Lovastatin and Pembrolizumab for the Treatment of Patients With Recurrent or Metastatic Head and Neck Cancer, LAPP Trial

NCT06636734

Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Human Papillomavirus-Related Neck Squamous Cell Carcinoma of Unknown Primary+20 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Intensity Modulated Proton or X-Ray Therapy After Surgery for Treatment of Head and Neck Cancer, the HEADLIGHT Study

Lovastatin and Pembrolizumab for the Treatment of Patients With Recurrent or Metastatic Head and Neck Cancer, LAPP Trial

Blood Tests and Questionnaires in Studying Adherence to Preventative Swallowing Exercises in Participants With Metastatic Head and Neck Cancer

Comparing an Investigational Scan (F-18 NaF PET/CT) to Standard of Care Imaging (F-18 FDG PET/CT) for Evaluating Vascular Complications in Patients Receiving Radiation Therapy for Head and Neck Cancer

Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study

Testing Immunotherapy Versus Observation in Patients With HPV Throat Cancer