NCT05979883

Randomized Evaluation of Machine Learning Assisted Radiation Treatment Planning vs Standard Radiation Treatment Planning

A Randomized Evaluation of Machine Learning Assisted Radiation Treatment Planning Versus Standard Radiation Treatment Planning

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cancer Head Neck
• Cancer, Head
• Cancer Neck

Interventions

Type	Name	Description
RADIATION	Machine Learning Assisted Radiation (MLAP) RapidPlan	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	Radiation Therapy Standard of Care (SOC)	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.

Timeline

• Start date: 2023-08-07
• Primary completion: 2025-10-29
• Completion: 2025-10-29
• First posted: 2023-08-07
• Last updated: 2026-01-26

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study