This phase II trial studies how well involved nodal radiation therapy works for the treatment of head and neck squamous cell cancer. In standard neck radiation, a majority of the neck receives a preventative dose of radiation in the hopes to treat any microscopic disease (disease that may be present but not seen on scans). Involved nodal radiation therapy targets radiation only onto the affected disease site to reduce the amount of radiation delivered to the surrounding normal tissue. This study may help doctors better understand how to best reduce the side effects of radiation therapy for the treatment of head and neck cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03953976.
PRIMARY OBJECTIVE:
I. To determine the risk of solitary elective volume recurrence following elective volume reduction using involved nodal radiation therapy (INRT).
SECONDARY OBJECTIVES:
I. Comparison of solitary elective volume recurrence (SEVR) risks by p16 status and anatomic site.
II. To determine patient-reported outcomes (PRO) following treatment with INRT.
III. To describe the rates of grade 3 and 4 acute and late toxicities following treatment with INRT.
IV. To estimate the rates of gastrostomy dependence at 3, 6, 12 and 24 months following treatment with INRT.
V. To characterize patient utilities following treatment with INRT.
VI. To determine 2-year overall and progression-free survival following treatment with INRT.
VII. To describe the patterns-of-failure following INRT.
OUTLINE:
Patients undergo INRT 5 days per week for 35 treatments in the absence of disease progression or unacceptable toxicity. Patients may also receive standard of care chemotherapy per investigator.
After completion of study treatment, patients are followed up at 1, 3, 6, 9, 12, 18, 24, 30, and 36 months.
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
Principal InvestigatorDavid Jonathan Sher
