Actively Recruiting
Treatment De-Escalation for Favorable Prognosis Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer Receiving Definitive Radiotherapy
Led by Georgetown University · Updated on 2026-04-17
30
Participants Needed
2
Research Sites
595 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The current standard treatment option for Human Papillomavirus (HPV) or p16-positive oropharyngeal cancer is full-dose radiation combined with chemotherapy. Results with chemotherapy combined with full-dose radiation therapy leads to high rates of cure; this has called into question whether therapy can be decreased in intensity since both chemotherapy and radiation have long-term side effects. One approach to decrease intensity of treatment is to give radiation alone (excluding chemotherapy) and to decrease radiation therapy dose. The investigator believes that omitting chemotherapy and decreasing radiation dose both to tumor and the regions of the head and neck at highest risk of potential spread, may have no significant impact on the cancer recurring while potentially leading to fewer long-term side effects.
CONDITIONS
Official Title
Treatment De-Escalation for Favorable Prognosis Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer Receiving Definitive Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 years or older at consent.
- Diagnosis of p16-positive and/or HPV-positive squamous cell carcinoma of the oropharynx.
- Clinical stage I-II (T1-2 N1 M0 or T3 N0-1 M0) according to AJCC 8th edition.
- Definitive chemoradiation would be standard care if standard radiation fractionation was used.
- Debulking of tumor allowed if gross unresected tumor remains.
- Agreement to biopsy FDG-avid areas on PET-CT 3-4 months post-treatment.
- Karnofsky Performance Status of 60 or higher within 8 weeks prior to registration.
- Neutrophil to lymphocyte ratio of 5 or less within 8 weeks prior to registration.
- Hemoglobin count of 10 or higher within 8 weeks prior to registration; transfusions allowed.
- Non-smoker for at least 6 months with 15 pack-year smoking history or less.
- Agreement to use contraception if of child-bearing potential during and 90 days after study.
- Ability and willingness to provide informed consent.
You will not qualify if you...
- Gross involvement of level 4 lymph nodes.
- Endophytic T3 disease as determined by the principal investigator.
- Any single lymph node larger than 4 cm.
- Nodal disease fixed to or invading adjacent neck muscles.
- Prior malignancy diagnosed within 2 years except treated nonmelanomatous skin cancer or Gleason 6 prostate cancer on active surveillance.
- Pregnant or nursing women.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
2
Medstar Southern Maryland Hospital Center
Clinton, Maryland, United States, 20735
Actively Recruiting
Research Team
P
Peter H Ahn, MD
CONTACT
N
Nicole Swanson
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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