What is the Purpose of this Study?
The purpose of this study is to determine whether using less intense radiation therapy and chemotherapy (chemoradiation) after trans-oral robotic surgery (TORS) will be as effective in treating HPV-associated oropharyngeal cancer as standard treatment while also reducing side effects. Patients will receive 3, 4, or 5 weeks of treatment depending on the extent of the disease at the time of surgery and the presence or absence of tumor tissue in the blood after the completion of surgery, instead of the standard 6-6.5 weeks of treatment. The chemotherapy drugs used in this study (cisplatin, or carboplatin and paclitaxel, if applicable) are approved by the U.S. Food and Drug Administration (FDA).
Eligibility
- * AJCC 8th edition T0-3N0-2 p16-positive oropharyngeal (tonsil, base of tongue, glossotonsillar sulcus, soft palate, oropharyngeal wall) squamous cell carcinoma or squamous cell carcinoma of unknown primary involving the cervical lymph nodes. Cytologic diagnosis from a cervical lymph node is sufficient for diagnosis in the presence of clinical evidence of a primary tumor in the oropharynx.
- * For patients with pT0 tumors (unknown primary), there must be at least one metastatic lymph node present in cervical level II.
- * p16 is strongly positive by immunohistochemistry or high-risk HPV is detected by in-situ hybridization.
- * Have undergone or will undergo gross total resection of all known disease in the head and neck via transoral robotic surgery. For patients with clinical unknown primary tumors, a patient must undergo both ipsilateral tonsillectomy and base of tongue resection unless the primary is identified clinically or pathologically at the time of surgery. If the primary is identified, then only resection of the primary site is required. If the primary tumor is resected with negative margins with a non-robotic surgery, such as a diagnostic tonsillectomy, this is considered acceptable and further robotic surgery is not necessary.
Where can I participate?
- CS Cancer Tarzana
- CS Cancer at Beverly Hills
- CS Cancer at Cedars-Sinai Medical Center
- CS Cancer at The Angeles Clinic and Research Institute
- Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer
More about this Clinical Trial
What is the full name of this clinical trial?
IIT2023-14-Zumsteg-ULTRA-HPV: Using CircuLating Tumor DNA to Risk Adapt Post-Operative Therapy for HPV-associated Oropharyngeal Cancer