Northwestern University
This clinical trial evaluates how decreasing the dose of radiation to the elective neck (areas of lymph nodes not directly involved in the cancer) impacts treatment outcomes in patients with human papillomavirus (HPV)-related oropharyngeal cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Radiation therapy plays an important role in the treatment of HPV-related oropharyngeal cancer, but it also causes significant toxicities. Given the significant toxicities associated with treatment, and the excellent outcomes of HPV-related oropharyngeal cancer, researchers are attempting to identify methods to de-escalate treatment for HPV-related oropharyngeal cancer in an effort to maintain excellent treatment outcomes while reducing the risk of toxicities. Reducing the dose of radiation therapy to the lymph nodes in the neck that aren't directly involved in the cancer may improve patient quality of life while still maintaining excellent rates of cure of disease.
PRIMARY OBJECTIVE: I. To determine 2-year locoregional progression free survival (LRPFS). SECONDARY OBJECTIVES: I. To determine 2-year progression free survival (PFS). II. To determine 2-year regional failure in the low-dose elective region. III. To determine 2-year overall survival (OS). IV. To determine physician-reported toxicities at 1, 3, 12-months as measured by Common Terminology Criteria for Adverse Events (CTCAE). V. To assess patient-reported toxicities at 1, 3, 12-months as measured by Functional Assessment of Cancer Therapy - Head \& Neck Radiotherapy Index (FACT-HN-Rad). OUTL…
Inclusion Criteria: * 3.1.1 Patients must have a histologically confirmed HPV-related OPSCC, confirmed by HPV insitu hybridization. * 3.1.2 Patients must not have received prior treatment (i.e., no induction chemotherapy). * 3.1.3 Patients must have evaluable disease (per RECIST v1.1 response criteria). See Section 6. * 3.3 for the evaluation of measurable disease. * 3.1.4 Patients must be age ≥ 18 years. * 3.1.5 Patients must have AJCC 8 th edition Stage I-II disease, as defined by a T-classification of T1-3, and N-classification of N1-2, without metastases (M0), as defined by physical exami…
Undergo CT
Undergo nasopharyngolaryngoscopy
Undergo PET
Ancillary studies
Undergo radiation therapy