This clinical trial tests how well machine learning assisted radiation treatment planning works to treat patients with head and neck cancer. Developing a quality treatment plan is very patient-specific, needing to consider individual characteristics of a patient’s anatomy, tumor location, and medical issues. Advances in machine learning and data science now enable predictive models which assist in creating an optimal plan based upon a patient’s tumor and normal tissue anatomy. Machine learning assisted radiation treatment planning works by submitting the patient's radiation plan to a machine learning program that will suggest additional improvements that could be made. Machine learning assisted radiation treatment may result in improved treatment outcomes for patients with head and neck cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05979883.
PRIMARY OBJECTIVE:
I. To compare scores on the swallowing subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck module (EORTC QLQ-H&N35) at 3 months post-radiotherapy between patients randomized to standard of care (SOC) versus machine learning assisted plan (MLAP).
SECONDARY OBJECTIVES:
I. To compare physician-reported toxicities as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 at 3 months post-radiotherapy across treatment arms.
II. To compare treatment plan quality metrics (PQMs) across treatment arms.
III. To compare time to complete treatment planning, which is defined as the time from the end of physician contouring to the time of physician approval across treatment arms.
EXPLORATORY OBJECTIVES:
I. To compare quality of life as measured by the 6 remaining subscales and 11 single item scores of the EORTC QLQ-H&N35 at 3 months post-radiotherapy across treatment arms.
II. To compare dose-volume histogram (DVH) statistics by treatment intent (definitive vs. adjuvant).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients' radiation treatment planning occurs per standard of care. Patients then undergo radiation therapy per the treatment plan.
ARM B: Patients' radiation treatment planning occurs per standard of care and treatment plan is then checked via the machine learning assisted planning module (RapidPlan). Patients then undergo radiation therapy per the treatment plan.
After completion of study intervention, patients are followed up at the end of radiation treatment and then 3 months after completion of radiation treatment.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorDaniel J. Ma
