Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06984861

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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