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 as determined by the PI.
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
Single group
Computed Tomography
Procedure/SurgeryUndergo CT
Nasopharyngeal Laryngoscopy
Procedure/SurgeryUndergo nasopharyngolaryngoscopy
Positron Emission Tomography
Procedure/SurgeryUndergo PET
Questionnaire Administration
Other interventionAncillary studies
Radiation Therapy
RadiationUndergo radiation therapy
2-year locoregional progression free survival
Response Evaluation Criteria in Solid Tumors version 1.1 will be used to assess tumor response. The 2-year progression free survival (PFS) estimate will be reported along with the confidence interval. Log-rank tests will be used to compare PFS across predefined subgroups. Cox proportional hazards models will be applied to assess the impact of covariates such as age, sex, baseline disease severity on PFS, when appropriate.
2-year PFS
Will be analyzed using the Kaplan-Meier method. Differences in survival distributions across patient subgroups will be evaluated using log-rank tests, and Cox models will be used to explore the effects of demographic and clinical variables on PFS.
2-year regional failure in the low-dose elective neck region
This will be assessed by comparing regional failures with the prior radiation plan, by overlaying radiation dose delivered to the area of nodal failure. Nodal failures in the 30 Gy volume will be considered elective neck failures.
2-year overall survival (OS)
Will be analyzed using the Kaplan-Meier method. Log-rank tests and Cox proportional hazards models may be used to explore differences in OS by covariates such as age, sex, and baseline disease severity when appropriate.
Incidence of physician-reported adverse events (AEs)
Will be measured by Common Terminology Criteria for Adverse Events version 6.0. Will generate adverse event summaries, which will include maximum grade and frequency, based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0. AEs will be graded as mild, moderate, severe, or life-threatening. All reported toxicities will be summarized by toxicity type and maximum grade, and sorted by the number of patients experiencing each toxicity. For each patient, the maximum grade of a given toxicity will be determined across all timepoints. AE data will be presented using categorical analyses and descriptive summary statistics. No formal statistical hypothesis testing will be performed.
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Northwestern University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
