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.
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.
3.2.1 Patients with cT4, cN3, or cM1 disease by AJCC 8 th edition.
3.2.2 Patients who have had prior RT to the head/neck region that would result in overlap of RT fields. 3.2.3 Patients who have had prior major surgery to the head/neck region that could disrupt lymphatic flow.
3.2.4 Patients who have an uncontrolled intercurrent illness that would interfere with the receipt of RT including, but not limited to any of the following, are not eligible: • Uncontrolled connective tissue disorders (e.g. lupus, scleroderma) given potential for this to interfere with RT • Psychiatric illness/social situations that would limit compliance with study requirements • Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
Northwestern University
Lead sponsor
National Cancer Institute (NCI)
Collaborator