De-escalation of Adjuvant Radiation for Low-Risk HPV Oropharyngeal Cancers
Recruiting now · Not applicable
Conditions studied: Oropharynx Cancer
In brief
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)
Key facts
- Study ID
- NCT06554158
- Run by
- Georgetown University
- People needed
- 30
- Starts
- 2019-08-01
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-03-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
- neutrophil:lymphocyte ratio ≤ 5 within 8 weeks of registration.
- hemoglobin count ≥ 10 within 8 weeks of registration. The patient may receive transfusion to reach this goal.
- current non-smoker (at least 6 months) with ≤ 15 pack-year smoking history
- start radiation within 8 weeks of resection (6 weeks preferable)
- have undergone resection of the primary site with Transoral Surgery and neck dissection of at least the ipsilateral neck
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and willingness to sign a written informed consent.
You may not qualify if…
- Perineural invasion at primary site
- Lymphovascular space invasion at primary site
- Level 4 nodal involvement (even if resected)
- Retropharyngeal nodal involvement (even if resected)
- any intact, unresected disease
- nodal disease pathologically invading adjacent neck musculature
- Patients treated via an invasive, non-oral approach to the primary site, including jaw-splitting mandibulotomy with resection or lateral pharyngotomy
- Prior history of malignancy diagnosed within 2 years prior to registration, except for nonmelanomatous skin cancer that has completed treatment and the patient is deemed as being disease-free or Gleason 6 prostate cancer that is undergoing active surveillance.
- Patient with extracapsular extension (ECE) who has not had a biopsy of an ipsilateral neck lymph node that demonstrated squamous cell carcinoma
Where it is running
- Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States (enrolling)
Full record on ClinicalTrials.gov
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