The study will evaluate the safety and effectiveness of a lower than standard dose of radiation for definitive or adjuvant treatment of head and neck squamous cell carcinomas.
In squamous cell carcinomas of the head and neck, regional recurrence is rare within lymph node stations treated with elective radiation. However, radiotherapy to the neck is toxic, and leads to a variety of unpleasant side effects, especially coupled with concurrent systemic therapy. There is growing evidence from previous studies showing that lower radiation doses may be adequate in preventing locoregional recurrence of disease. The hypothesis is that lower dose of radiation will have equal effectiveness but less toxicity than standard approaches for the treatment of squamous cell carcinomas of the head and neck. The study evaluates the effectiveness and safety of reduced dose radiotherapy for definitive and adjuvant treatment of Human papillomavirus (HPV) positive oropharyngeal squamous cell carcinomas. Participants will be treated with a radiation therapy regimen that has a lower dose to less tissue area (dose and volume de-escalation) than standard of care radiation therapy. The dosing will be determined by whether concurrent chemotherapy will be given, results from on treatment HPV blood test called NavDx, physical exam, and imaging. On treatment NavDx results indicating a slow (non-rapid) response to the treatment will receive an additional boost of radiation. Routine NavDx testing will be performed to assess treatment response and recurrence. Participants will also be asked to complete surveys about overall health and wellbeing.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
External Beam Radiation to Head and Neck
Miami Cancer Institute
Miami, Florida, United States
RECRUITINGUniversity of Virginia
Charlottesville, Virginia, United States
RECRUITINGEastern Virginia Medical School
Norfolk, Virginia, United States
To assess the disease control of participants who receive dose and volume-de-escalated radiotherapy to the neck, guided by treatment response through circulating tumor-modified HPV DNA testing
Incidence of disease free survival as measured by circulating HPV on Nav Dx blood tests.
Time frame: up to 2 years after radiotherapy
To assess safety for treatment with reduced dose and volume-de-escalated radiotherapy to the neck
Incidence of grade 3 (or greater) adverse events as defined by the CTCAE v5.0
Time frame: Evaluated through 6 months and 1 year post- radiation.
To estimate quality of life of participants who receive reduced dose and volume-de-escalated radiotherapy to the neck
Quality of life as determined by the EORTC H\&N35. Questions are scaled from 1-4 with 1 meaning the symptom/problem was not experienced and 4 meaning the symptom/problem was experienced at a high level.
Time frame: up to 2 years after radiotherapy
To estimate quality of life of participants who receive reduced dose and volume-de-escalated radiotherapy to the neck
Quality of life as determined by the EORTC QLQ-C30. Majority of questions are scaled from 1-4 with 1 meaning the symptom/problem was not experienced and 4 meaning the symptom/problem was experienced at a high level. Two questions are scaled from 1-7 with 1 meaning very poor (worse outcome) and 7 meaning excellent (best outcome).
Time frame: up to 2 years after radiotherapy
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Bon Secours
Richmond, Virginia, United States
NOT_YET_RECRUITINGVirginia Commonwealth University
Richmond, Virginia, United States
RECRUITING