Actively Recruiting
A Study Comparing Personalized Radiation Therapy With Standard Radiation Therapy in People With HPV-Positive Throat Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-23
291
Participants Needed
9
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The researchers are doing this study to find out if a personalized approach to chemoradiation therapy (which may include a lower dose of radiation) is as effective as the standard chemoradiation therapy in people with HPV-positive throat cancer. Other purposes of this study include looking at the following: * Whether a lower dose of radiation in combination with standard chemotherapy causes fewer side effects than the standard dose of radiation therapy in combination with standard chemotherapy * How the study approaches (lower dose of radiation therapy + standard chemotherapy and standard dose of radiation therapy + standard chemotherapy) affect participants' quality of life. The researchers will measure quality of life by having participants fill out questionnaires.
CONDITIONS
Official Title
A Study Comparing Personalized Radiation Therapy With Standard Radiation Therapy in People With HPV-Positive Throat Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed HPV-associated squamous cell carcinoma of the oropharynx or squamous cell carcinoma with unknown primary
- Positive test for both p16 expression (70% nuclear and cytoplasm) and mRNA HPV in situ hybridization
- Clinical stage Tx-2, N1-2c without distant metastasis based on FDG PET/CT
- ECOG Performance Status 0-1 or Karnofsky Performance Status ≥70
- Age 18 years or older
- Adequate blood counts within 30 days prior to registration (WBC ≥2 K/mcL, ANC ≥1500 cells/mm³, platelets ≥100,000 cells/mm³, hemoglobin ≥10.0 g/dl)
- Adequate kidney function within 30 days prior to registration (serum creatinine <1.5 mg/dl or creatinine clearance ≥50 ml/min)
- Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
- Provided study-specific informed consent
- Ability to undergo MRI scans if participating in optional protocol section
You will not qualify if you...
- Prior head and neck radiation therapy with >30% overlap with current treatment fields (exceptions possible)
- Tumors borderline T4 due to extension to extrinsic tongue muscles
- Simultaneous primary cancers outside the oropharynx (exceptions possible)
- Prior invasive malignancy unless disease-free for 3 years or with a cure rate ≥90% at 5 years
- Prior systemic chemotherapy for the study cancer
- Use of particle therapy
- Non-compliance with protocol activities
- Contraindications to cisplatin or carboplatin/5-fluorouracil at prescribed doses
- Severe active comorbidities including recent unstable angina, heart failure, myocardial infarction, acute infections requiring IV antibiotics, recent respiratory illness hospitalization, or hepatic insufficiency with jaundice or coagulation defects
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 9 locations
1
Hartford Healthcare (Data Collection Only)
Hartford, Connecticut, United States, 06102
Actively Recruiting
2
Baptist Alliance MCI (Data Collection Only)
Miami, Florida, United States, 33143
Actively Recruiting
3
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
4
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
5
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
6
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
7
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
8
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
9
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
N
Nancy Lee, MD
CONTACT
N
Nadeem Riaz, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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