Actively Recruiting
Adaptive De-escalation of Radiation Therapy Dose in HPV-Positive Oropharyngeal Carcinoma Demonstrating Favorable Mid-Treatment Response
Led by NYU Langone Health · Updated on 2026-01-06
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatment options for people with HPV-positive oropharyngeal carcinoma, a type of throat cancer. This phase II clinical trial aims to see if reducing the intensity of chemoradiation based on how tumors respond mid-treatment is feasible. The study focuses on progression-free survival at 2 years and also looks at survival, quality of life, and long-term side effects. It includes testing for HPV markers in blood and saliva and uses imaging to predict outcomes. Participants receive radiation therapy combined with chemotherapy drug cisplatinum. Those showing a strong tumor response at 4 weeks may have their radiation dose lowered and duration shortened, with different groups receiving varying treatment lengths and doses based on tumor shrinkage and HPV DNA clearance. Some groups receive standard treatment, while others receive de-escalated radiation schedules to reduce treatment burden. During the study, patients undergo scans and blood tests to monitor tumor response and HPV DNA levels. Quality of life questionnaires and assessments of side effects are completed to understand treatment impact. The main measure is progression-free survival at 2 years, with ongoing follow-up to assess disease control and long-term effects. Participation lasts through treatment and extends to at least 2 years for outcome evaluation.
CONDITIONS
Brief Title
Adaptive Treatment De-escalation in Favorable Risk HPV-Positive Oropharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with squamous cell carcinoma of the oropharynx including tonsil, base of tongue, soft palate, or posterior oropharyngeal wall
- Tumor tissue positive for p16 by immunohistochemical staining (>70% staining)
- Detectable HPV circulating tumor DNA in plasma at screening
- Clinical cancer stage T1 to T3, N1 to N2b with no distant metastases
- Fiberoptic exam and specific imaging within 8 weeks prior to registration
- Smoking history not exceeding 10 pack-years
- Zubrod Performance Status of 0-1 within 8 weeks prior to registration
- Adequate blood counts and kidney function within 2 weeks prior to registration
- Negative pregnancy test for women of childbearing potential within 14 days prior to registration
- HIV positive patients allowed if no AIDS-defining illness and adequate CD4 count
- Immune to hepatitis B or negative for hepatitis B and C
- Provided informed consent prior to study entry
You will not qualify if you...
- Missing or undetectable baseline plasma HPV DNA
- Cancer from oral cavity sites, nasopharynx, hypopharynx, or larynx
- Carcinoma of unknown primary origin
- Distant metastasis or adenopathy below the clavicles
- Complete surgical removal of both primary and nodal disease
- Simultaneous or bilateral primary cancers
- Prior invasive malignancy unless disease free for at least 3 years
- Prior systemic chemotherapy for this cancer
- Prior radiotherapy overlapping the study treatment area
- Severe active medical conditions such as unstable heart disease, recent heart attack, serious infection, or severe respiratory illness
- Hepatic insufficiency with clinical jaundice or coagulation defects
- AIDS based on CDC definition with significant immune compromise
- Pregnancy
- Prior allergic reaction to cisplatin
- MRI exclusion criteria including presence of certain implants, claustrophobia, history of seizures
- Severe kidney impairment preventing contrast MRI scans
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 - 5 to 7 weeks
Participants receive radiation therapy and chemotherapy with the treatment plan adapted based on mid-treatment response. This includes standard radiation therapy with cisplatinum or dose-deescalated radiation therapy with weekly cisplatinum for 5 to 7 weeks depending on response.
Weekly visits for radiation and chemotherapy administration
Trial Site Locations
Total: 1 location
1
New York University School of Medicine
New York, New York, United States, 10016
Actively Recruiting
Research Team
K
Kenneth Hu
F
Fraustina Hsu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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