Actively Recruiting
Major Radiation Dose De-Escalation Concurrent With Chemotherapy for Advanced Stage Human Papilloma Virus Associated Oropharyngeal Carcinoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-11
74
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether lower doses of radiation therapy combined with standard chemotherapy can effectively treat people with Human Papilloma Virus (HPV)-positive throat cancer. This Phase 2 study compares reduced radiation therapy to the standard radiation dose, aiming to find if fewer treatments over a shorter time work as well. The chemotherapy drugs used include cisplatin, carboplatin, and 5-fluorouracil (5-FU). Participants start with 6 weeks of standard induction chemotherapy. If their cancer shrinks to certain stages and they show no signs of hypoxia on a special PET/CT scan called 18F-FMISO, they receive a reduced radiation dose of 30Gy along with 2 cycles of chemotherapy. If hypoxia is detected, they continue with the standard radiation dose of 70Gy plus 3 cycles of chemotherapy. An optional baseline 18F-FMISO scan is also offered. During the study, participants undergo imaging scans, including 18F-FMISO PET/CT and FDG PET scans, to assess their cancer and hypoxia status. They also complete questionnaires about their health and quality of life. The primary outcome measured is locoregional control of the cancer over 2 years. Safety and treatment effects are monitored as participants receive radiation and chemotherapy over several weeks.
CONDITIONS
Brief 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 from biopsy or surgical resection
- Squamous cell carcinoma of the neck of unknown primary with biopsy proof allowed
- Evidence of HPV positivity by p16 expression and mRNA HPV testing
- Clinically or radiographically measurable disease at primary tumor site or lymph nodes
- Tumor stage T3-4/N0-2c or any N3 regardless of T stage, without distant metastasis
- CT or MRI scan of the neck with and without contrast as planning tools
- ECOG Performance Status 0-2 or Karnofsky Performance Status ≥ 70
- Age 18 years or older
- Adequate blood counts within 30 days before registration
- Adequate kidney function within 30 days before registration
- Adequate liver function within 30 days before registration
- Negative pregnancy test within 14 days before registration for women of childbearing age
- One cycle of induction chemotherapy allowed before registration
- Ability to undergo MRI scans unless medically contraindicated
You will not qualify if you...
- Prior radiation therapy to head and neck
- Simultaneous primary cancers outside the oropharynx unless approved by study leadership
- Prior invasive malignancy unless disease free for 3 years or high cure rate
- Prior systemic chemotherapy for the study cancer
- Severe active medical conditions such as unstable angina, recent heart attack, active infections requiring IV antibiotics, recent severe lung illness, or liver failure causing jaundice or clotting issues
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.
Duration - 6 weeks
Participants receive 6 weeks of induction chemotherapy with carboplatin, paclitaxel, and cetuximab.
Duration - 1 day
Participants undergo an 18F-FMISO PET/CT scan at 8 to 10 days into chemoradiation to assess tumor hypoxia.
1 visit (in-person)
Duration - Approximately 3 weeks
Participants receive reduced radiation therapy (30Gy over 15 days) concurrent with 2 cycles of chemotherapy if no hypoxia is detected; otherwise, standard radiation therapy (70Gy) with 3 cycles of chemotherapy is given.
Daily radiation therapy visits for 15 days and chemotherapy visits as scheduled
Duration - 2 years
Participants are monitored for treatment outcomes including locoregional control over 2 years after completion of therapy.
Periodic follow-up visits
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
N
Nadeem Riaz, MD
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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