A Phase II Study of Post-Resection Radiation Dose and Treatment Site De-Escalation for Favorable Prognosis Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer
Georgetown University
Summary
The goal of this clinical trial is to learn whether for intermediate-risk patients who have undergone Transoral Robotic Surgery for HPV/p16(+) oropharyngeal cancer and have minimal smoking history, whether these patients can be treated with a lower-than standard dose, with omission of the primary site in the oropharynx. The main questions it aims to answer are: Does radiotherapy site and dose-de-escalation lead to similar outcomes compared to historical data on tumor control in patients who are treated with standard radiation doses and treatment fields? Participants will: Undergo treatment with a lower than standard radiation dose (50Gy in 25 fractions, with either Intensity Modulated Radiation Therapy (IMRT) or proton beam therapy) and to a smaller than standard radiation field (to the neck only, excluding the original site of tumor in the oropharynx)
Description
HPV+ oropharyngeal carcinoma can be treated with either definitive radiotherapy or transoral surgery (TOS, using a predominantly robotic or laser approach), with equivalent oncologic results.23 The proportion of patients who receive definitive radiotherapy or TOS followed by adjuvant radiotherapy (in over 80% of patients) has roughly reached parity. At large academic centers with significant head and neck cancer expertise, the decision to treat with either definitive radiation or TOS followed by adjuvant radiotherapy is driven by non-oncologic considerations most often dictated by anatomic fac…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Patients must be ≥ 18 years of age on the day of signing informed consent. * Patients must have a diagnosis of p16+ and/or HPV+ squamous cell carcinoma of the oropharynx (including base of tongue, glossotonsilar sulcus, tonsil, soft palate, vallecula, and/or posterior oropharyngeal wall). * pathologic stage T1-2 N1 M0 (AJCC 8th ed.) stage I or T3 N0-1 M0 stage II (AJCC 8th ed.) SCCA of the oropharynx, with ≤ 5 distinct nodes involved with tumor, ≤ 2mm ECE (extracapsular extension), ≥ 2mm surgical margins at primary site. * Karnofsky Performance Status (KPS) ≥ 60 within 8…
Interventions
- RadiationRadiation Therapy
De-escalation of Adjuvant Radiotherapy
Location
- Medstar Georgetown University HospitalWashington D.C., District of Columbia