RecruitingNot ApplicableNCT06554158

De-escalation of Adjuvant Radiation for Low-Risk HPV Oropharyngeal Cancers

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

Sponsor

Georgetown University

Enrollment

30 participants

Start Date

Aug 1, 2019

Study Type

INTERVENTIONAL

Conditions

Oropharynx Cancer

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)

Eligibility

Min Age: 18 Years

Inclusion Criteria11

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.

Exclusion Criteria9

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