The purpose of this study is to determine the magnitude of clinical benefit achieved through machine learning assisted radiation treatment planning (MLAP) on post-treatment clinical outcomes such as acute toxicity and patient reported outcomes.
This is a randomized phase III trial to evaluate the effectiveness of MLAP compared to Standard of Care. Patients will undergo a randomization procedure with a variable allocation ratio where the first third of patients are randomized 3:1 in favor of SOC, the next third randomized 1:1, and the last third randomized 1:3 in favor of MLAP. This is done to give dosimetrists time to optimize the MLAP workflow. Since the treatment team may learn to improve their treatment planning process in the SOC arm through interactions with RapidPlan, as a sensitivity analysis, the primary and secondary goals will be re-analyzed including time of registration as a moderator of the treatment effect.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
204
Radiation therapy simulation, target delineation, dosing, localization, and follow-up will be followed per standard of care practices and/or at the discretion of the treating radiation oncologist. To elaborate, patients will receive a treatment planning CT (computed tomography) scan, followed by normal tissue delineation through the physician and/or medical dosimetry assistant, followed by target delineation by the physician, followed by radiation treatment planning with the dosimetrist and medical physicist. The preliminary plan will be run through the RapidPlan module, which will give a list of possible improvements to the plan. The dosimetrist will then make an amendment to the plan according to RapidPlan suggestions, followed by plan change requests and approval by the physician.
Radiation therapy simulation, target delineation, dosing, localization, and follow-up will be followed per standard of care practices and/or at the discretion of the treating radiation oncologist. To elaborate, patients will receive a treatment planning CT (computed tomography) scan, followed by normal tissue delineation through the physician and/or medical dosimetry assistant, followed by target delineation by the physician, followed by radiation treatment planning with the dosimetrist and medical physicist, followed by plan change requests and approval by the physician.
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, United States
Change in swallowing score
Will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck module (EORTC QLQ-H\&N35). The EORTC QLQ-H\&N35 is a 35-item questionnaire used to assess symptoms encountered specifically by patients with head and neck cancer. The H\&N35 consists of 7 multiple-item scales (Pain, Swallowing, Senses, Speech, Social eating, Social contact, and Sexuality), in addition to 11 single items (e.g., Opening mouth, Sticky saliva, Dry mouth, etc.). Scores are combined into an overall score ranging from 0=Best to 100=Worst. Swallowing score will be measured at baseline (up to 30 days prior to treatment planning), at the end of Radiation Treatment (+ 14 days), and 3 months post Radiation Treatment (+/-30 days from 3 months post-radiotherapy).
Time frame: Baseline (up to 30 days prior to treatment planning); up to 6 months
Change in physician-reported toxicities
Assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Toxicities will be recorded at baseline (up to 30 days prior to treatment planning), at the end of Radiation Treatment (+14 days), and 3 months post Radiation Treatment (+/-30 days from 3 months post-radiotherapy).
Time frame: Baseline; up to 6 months
Difference in treatment plan quality metrics (PQMs) across treatment arms
Treatment PQM is a continuous-valued function depending on selected dose-volume histogram statistics for 5 organs-at-risk. Comparisons between treatment arms will be made.
Time frame: Baseline; up to 6 months
Difference in time to complete treatment planning
Treatment planning time is defined as the time in minutes from the end of physician contouring to the end of physician plan approval.
Time frame: Baseline; up to 6 months
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Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, United States