Actively Recruiting
Phase III Randomized Double-blinded Trial Comparing Personalized De-escalated Radiation Versus Standard Radiation in HPV Positive Oropharyngeal Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-06-03
291
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a personalized approach to chemoradiation therapy compared to standard chemoradiation therapy in people with HPV-positive throat cancer. This study aims to find out if using a lower dose of radiation with standard chemotherapy is as effective as the standard radiation dose combined with chemotherapy. The study also looks at whether the lower radiation dose causes fewer side effects and how each treatment affects patients' quality of life, measured through questionnaires. Participants will be randomly assigned to one of two treatment groups. One group receives personalized chemoradiation therapy where radiation dose is adjusted based on tumor hypoxia detected by a special FMISO-PET scan; hypoxia-negative patients receive 30 Gy of radiation, while hypoxia-positive patients receive 70 Gy. The other group receives the standard chemoradiation therapy of 70 Gy radiation regardless of hypoxia status. Both groups receive concurrent chemotherapy as per guidelines. After treatment, a PET/CT scan is done about four months later to check for persistent disease, and further standard care is provided as needed. During the study, participants will undergo the FMISO-PET scan, routine chemotherapy and radiation treatments, and quality of life assessments using specific questionnaires. Researchers will monitor overall survival over two years as the primary outcome. Safety and treatment effects will be evaluated through follow-up scans and clinical assessments. Participation involves regular visits for scans, treatments, and questionnaires, with the study lasting at least two years to assess outcomes.
CONDITIONS
Brief 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...
- Diagnosis of HPV-associated squamous cell carcinoma of the oropharynx or squamous cell carcinoma with unknown primary confirmed by pathology
- Positive test for both p16 expression and HPV mRNA by approved methods
- Clinical stage Tx-2, N1-2c without distant metastasis by FDG PET/CT
- ECOG performance status 0-1 or Karnofsky Performance Status ≥70
- Age 18 years or older
- Adequate blood cell counts within 30 days before registration
- Adequate kidney function within 30 days before registration
- Negative pregnancy test within 14 days before registration for women of childbearing potential
- Ability to provide informed consent
- Able to undergo MRI scans (optional)
You will not qualify if you...
- Prior head and neck radiation with >30% overlap with current treatment area (exceptions possible)
- Tumors borderline T4 with anterior extension to tongue muscles
- Simultaneous primary cancers outside the oropharynx (exceptions possible)
- Prior invasive malignancies unless disease-free for 3 years or high cure rate
- Prior systemic chemotherapy for current throat cancer
- Use of particle therapy
- Non-compliance with study procedures
- Contraindications to receive cisplatin or carboplatin/5-fluorouracil at prescribed doses
- Severe active conditions such as unstable angina, recent heart attack, serious infections requiring IV antibiotics, recent severe lung illness, or liver failure causing jaundice or coagulation problems
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 15 to 25 days
Participants receive personalized or standard chemoradiation therapy with concurrent chemotherapy. Radiation dose and duration depend on hypoxia status and treatment arm.
Daily visits for radiation treatment over 3 to 5 weeks
Duration - 1 day during treatment
Participants undergo an FMISO-PET scan during the second week of radiation treatment to assess tumor hypoxia.
1 scan session (in-person)
Duration - Approximately 4 months
Participants have a post-treatment FDG PET/CT scan about 4 months after completing therapy to check for persistent disease and may have additional care based on findings.
1 follow-up visit (in-person)
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
N
Nadeem Riaz, MD
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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