Actively Recruiting
Radiation De-Escalation Pilot Study for p16-Negative Oropharyngeal and p16-Negative or Positive Laryngeal and Hypopharyngeal Cancers
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-27
12
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a treatment approach involving reduced radiation and chemotherapy followed by planned neck dissection surgery in people with head and neck cancer. This phase 2 study focuses on patients with squamous cell carcinoma of the head and neck who test negative for hypoxia using a special PET/CT scan. The goal is to see how effective this de-escalated treatment is against their cancer. Participants who are hypoxia-negative will receive chemoradiation therapy with lower radiation doses to certain areas, combined with two cycles of standard chemotherapy drugs like cisplatin or carboplatin/5-Fluorouracil. Those who test positive for hypoxia on the PET/CT scan will be removed from the study and receive the standard higher radiation dose treatment. The study uses 18F-FMISO PET/CT to determine hypoxia status and adjusts radiation doses accordingly. During the study, participants will undergo imaging scans including PET/CT, CT, or MRI of the neck, as well as blood tests to monitor their health and organ function. The main outcome measured is the number of participants alive 2.5 years after chemoradiation therapy. Participants must meet specific health criteria and will be followed throughout treatment and after to assess their response and survival.
CONDITIONS
Brief Title
A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed squamous cell carcinoma of the head and neck excluding nasopharynx, nasal cavity/paranasal sinus, oral cavity, salivary, thyroid, and cutaneous primaries
- Unknown primary SCC with radiographically detectable gross nodes allowed with biopsy confirmation
- P16 IHC negative if primary site is oropharynx or unknown; any P16 status accepted for hypopharynx or larynx
- Clinical stage T0-3 N1-2C M0 without distant metastasis by FDG PET/CT
- Age 18 years or older
- No prior radiation therapy or chemotherapy for head and neck cancer
- Primary tumor removed by surgery allowed if residual grossly enlarged, radiographically detectable lymph nodes remain
- Karnofsky Performance Status (KPS) of 70 or higher
- CT or MRI of the neck with and without contrast
- Adequate blood counts, renal, and liver function within 30 days prior to registration
- Negative serum pregnancy test within 14 days prior for women of childbearing potential
- Signed informed consent obtained prior to study entry
You will not qualify if you...
- Nasopharyngeal, nasal cavity/paranasal sinus, oral cavity, salivary gland, thyroid, and cutaneous primary malignancies
- Clinical stage T4 or N3
- Prior radiotherapy to head and neck region
- Prior systemic chemotherapy for head and neck cancer
- Chemotherapy or radiotherapy within last 3 years
- Prior surgical resection for same disease except biopsy or surgery removing primary tumor with residual nodal disease
- Prior invasive malignancy unless disease free for 3 years or high cure rate
- Simultaneous primary cancers outside oropharynx unless approved by investigators
- Pregnant or breastfeeding women
- Severe active co-morbidities including recent unstable angina, heart failure hospitalization, recent myocardial infarction, infections requiring IV antibiotics, recent respiratory illness requiring hospitalization, or hepatic insufficiency causing jaundice or coagulation defects
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 - Duration of chemoradiation therapy as per protocol
Participants receive chemoradiation therapy with de-escalated radiation concurrent with 2 cycles of chemotherapy after being confirmed hypoxia-negative by 18F-FMISO PET/CT scan performed 5 to 10 days after radiation therapy starts.
1 visit for 18F-FMISO PET/CT scan and multiple visits for chemoradiation therapy and chemotherapy
Trial Site Locations
Total: 6 locations
1
Memorial Sloan Kettering 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 @ 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
Research Team
Z
Zeinab Abou Yehia, MD
E
Eric Sherman, 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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