Actively Recruiting
A Study of Reduced Radiation Therapy and Standard-of-Care Chemotherapy in People With HPV-Positive Throat Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-23
121
Participants Needed
7
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to find out if lower doses of radiation may help reduce the side effects of radiation therapy in combination with standard-of-care chemotherapy in people with HPV-positive throat cancer. The chemotherapy drugs used in this study include cisplatin, carboplatin, and 5-fluorouracil (5- FU), paclitaxel and abraxane- (Albumin-bound Paclitaxel).
CONDITIONS
Official Title
A Study of Reduced Radiation Therapy and Standard-of-Care 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 resection
- Squamous cell carcinoma of unknown primary with excisional or core biopsy or PI/co-PI consent
- Measurable gross disease at primary tumor or nodal sites
- Oropharyngeal carcinoma without distant metastasis by FDG PET/CT
- CT or MRI of the neck with and without contrast performed
- ECOG Performance Status 0-2 or Karnofsky Performance Status ≥ 50
- Age 18 years or older (patients over 70 may enroll only in Cohort B)
- Adequate blood counts within 30 days prior to registration: WBC ≥ 2 K/mcL, ANC ≥ 1000 cells/mm3, platelets ≥ 100,000 cells/mm3, hemoglobin ≥ 8.0 g/dl
- Adequate kidney function within 30 days prior: serum creatinine < 1.5 mg/dl or creatinine clearance ≥ 50 ml/min
- Adequate liver function within 30 days prior: bilirubin < 2 mg/dl, AST or ALT < 3 times the upper limit of normal
- Negative pregnancy test within 14 days prior for women of childbearing potential
- Able to undergo MRI scans unless medically contraindicated or approved by PI/co-PI
- Provide informed consent before study entry
You will not qualify if you...
- Prior head and neck radiation therapy
- Simultaneous primary cancers outside the oropharynx unless approved by PI/co-PI
- Prior invasive malignancy (except non-melanoma skin cancer) unless disease-free for 3 years or cure rate ≥ 90% at 5 years
- Prior systemic chemotherapy for the study cancer (chemotherapy for other cancers allowed)
- Severe active illnesses such as unstable angina, heart failure requiring hospitalization in past 6 months
- Myocardial infarction within past 6 months
- Active bacterial or fungal infection requiring intravenous antibiotics at registration
- Recent severe respiratory illness requiring hospitalization or precluding study therapy within 30 days
- Hepatic insufficiency causing clinical jaundice or blood clotting defects
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Cancer Center at 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 Cancer Center at 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
H
Heiko Schoder, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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