Actively Recruiting
Treatment De-Escalation for Favorable Prognosis Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer Receiving Definitive Radiotherapy A Phase II Study of Treatment De-Escalation for Favorable Prognosis, Stage I-II Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer
Led by Georgetown University · Updated on 2026-04-17
30
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a treatment approach for patients with favorable prognosis Human Papillomavirus (HPV) or p16-positive oropharyngeal cancer. This research focuses on reducing the intensity of radiation therapy by omitting chemotherapy and lowering the radiation dose to the tumor and nearby areas at highest risk of cancer spread. The study aims to see if this adjusted treatment maintains cancer control while potentially reducing long-term side effects compared to the current standard combined chemotherapy and full-dose radiation therapy. The treatment being studied involves giving radiation therapy alone, with a total dose of 66 Gray (Gy) directed at the visible tumor. This approach excludes chemotherapy to assess if the cancer control remains effective with this lower intensity treatment. The study includes a single treatment group receiving this radiation-only therapy. Participants will be followed to measure several outcomes over two years, including progression-free survival, local and regional control of cancer, distant metastasis-free survival, overall survival, and quality of life. Additional evaluations include clinical and radiographic responses, rates of feeding tube placement, and neck dissection. Monitoring involves biopsies of active areas on PET-CT scans 3 to 4 months after treatment. The total study duration for participants includes these assessments and follow-up visits to track treatment effects and safety.
CONDITIONS
Brief 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 of age or older at the time of signing informed consent.
- Diagnosis of p16-positive and/or HPV-positive squamous cell carcinoma of the oropharynx.
- Clinical stage I or II (T1-2 N1 M0, or T3 N0-1 M0) according to AJCC 8th edition.
- Debulking surgery allowed if gross unresected tumor remains.
- Agree to biopsy of FDG-avid areas on PET-CT 3 to 4 months after treatment.
- Karnofsky Performance Status (KPS) score of 60 or higher within 8 weeks before registration.
- Neutrophil to lymphocyte ratio of 5 or less within 8 weeks before registration.
- Hemoglobin count of at least 10 within 8 weeks before registration; transfusions allowed to meet this.
- Current non-smoker for at least 6 months with 15 or fewer pack-year smoking history.
- Agree to use adequate contraception during and for 90 days after study participation if of child-bearing potential.
- Ability to understand and willingness to sign 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 (multiple nodes totaling more than 4 cm allowed).
- Lymph node disease fixed to or invading adjacent neck muscles.
- History of malignancy diagnosed within 2 years prior to registration, except treated nonmelanomatous skin cancer or low-risk prostate cancer under surveillance.
- Pregnant or nursing women.
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 - Duration of radiation therapy (not specified)
Participants receive radiation therapy only to a dose of 66Gy to gross disease as the main treatment.
Duration - Up to 2 years
Participants are monitored for disease control, survival, and quality of life after completing radiation therapy.
Visits occur periodically over 2 years for assessments including clinical, radiographic, and quality of life evaluations.
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
N
Nicole Swanson
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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