Locally Advanced Head and Neck Cancer (HPV-negative)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Biopsy proven diagnosis of squamous cell carcinoma of HNC originating in the oropharynx, hypopharynx, larynx, or oral cavity (base of tongue) • The primary radiotherapy with curative intend, either in combination with chemotherapy or not • Inoperable locally advanced disease, defined as: • AJCC 8th stage = III • T stage =2 • Negative for HPV by p16 IHC or ISH
Exclusion criteria
Exclusion criteria: • Previous radiation treatment in the head and neck region • Head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies • Pregnant or breast-feeding females • Patients younger than 18 years • Patients with ECOG performance score of 2 or lower • Contraindications to MRI • Patients that continue to smoke or abuse alcohol during treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severe unacceptable local adverse events which are radiotherapeutically attributable. Specifically, CTCAEv5 grade 4 mucositis, dermatitis or aspiration that does not resolve to a grade =3 in 3 months, and CTCAEv5 grade=3 myelopathy, and/or osteonecrosis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rates of grade 3 toxicity in 3 to 6 months after radiation oncology. Specifically, CTCAEv5 grade 3 mucositis, dermatitis, aspiration, dysphagia, hearing impaired, xerostomia, weight loss, trismus, hoarseness, oropharyngeal pain. | — |
Contacts
MD Andeson Cancer Center