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

Launched by GEORGETOWN UNIVERSITY · Aug 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether patients with low-risk HPV-related oropharyngeal cancer can be effectively treated with a lower dose of radiation and a smaller treatment area. The researchers want to find out if this approach can achieve the same results in controlling the cancer as the standard higher-dose radiation treatment. The trial is for adults aged 18 and older who have been diagnosed with specific types of HPV-positive oropharyngeal cancer and have undergone surgery to remove the tumor.

To participate, patients must meet certain criteria, such as being current non-smokers with a limited smoking history, having a good overall health score, and having undergone a specific type of surgery. Those who join the trial will receive radiation treatment that targets only the neck area, excluding the original tumor site, with a lower total radiation dose than usual. This study is currently recruiting participants, and it aims to provide new insights into how to treat this type of cancer more safely and effectively.

Gender

ALL

Eligibility criteria

• 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 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 Criteria:
• • 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