Actively Recruiting
A Study of Reduced Radiation Therapy With Chemotherapy in People With HPV-Positive Throat Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-11
74
Participants Needed
7
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study of Reduced Radiation Therapy With Chemotherapy 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 (tonsil, base of tongue, or oropharyngeal walls) from biopsy or surgical samples
- Squamous cell carcinoma of neck with unknown primary allowed if biopsy done and HPV positive
- Clinically or radiographically measurable disease at primary site or lymph nodes
- Tumor stage T3-4 or nodal stage N0-2c or any N3 (AJCC 7th Edition) HPV positive oropharyngeal cancer
- Neck CT with contrast or MRI with and without contrast for radiation planning
- ECOG performance status 0 to 2 or Karnofsky score 70 or higher
- Age 18 years or older
- Adequate blood counts within 30 days before registration (WBC ≥ 2 K/mcL, ANC ≥ 1,000/mm³, platelets ≥ 100,000/mm³, hemoglobin ≥ 8.0 g/dl)
- Adequate kidney function within 30 days before registration (serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 50 ml/min)
- Adequate liver function within 30 days before registration (bilirubin ≤ 2 mg/dl, AST or ALT ≤ 3 times upper limit of normal)
- Negative pregnancy test within 14 days before registration for women of childbearing potential
- One cycle of induction chemotherapy allowed before registration
- Ability to undergo MRI scans unless medically contraindicated or approved by study doctors
- Provided informed consent before study entry
You will not qualify if you...
- Prior radiation therapy to head and neck
- Simultaneous primary cancers outside the oropharynx unless approved by study doctors
- Prior invasive cancer within 3 years unless high cure rate at 5 years
- Prior chemotherapy for this cancer
- Severe active heart conditions (unstable angina, heart failure requiring hospitalization within 6 months, recent myocardial infarction within 6 months)
- Active severe infections requiring IV antibiotics at registration
- Recent severe lung disease exacerbation or respiratory illness preventing study therapy within 30 days
- Liver failure causing jaundice or blood clotting problems
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
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
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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