De-escalation of Adjuvant Radiation for Low-Risk HPV Oropharyngeal Cancers
ConditionOropharynx Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeorgetown University
About this trial
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)
Eligibility criteria
Qualifiers
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 weeks prior to registration.
Disqualifiers
Perineural invasion at primary site
Lymphovascular space invasion at primary site
Level 4 nodal involvement (even if resected)
Retropharyngeal nodal involvement (even if resected)
Trial design
Treatments tested in this trial
- Radiation Therapy
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Georgetown University
Lead sponsor
MedStar Georgetown University Hospital
Collaborator
Source ClinicalTrials.gov