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

Mayo Clinic

Status: Completed

Conditions: Cancer Head Neck; Cancer Neck; Cancer, Head

Treatments: Radiation: Radiation Therapy Standard of Care (SOC); Radiation: Machine Learning Assisted Radiation (MLAP) RapidPlan

Study type: Interventional

Funder types: Other

Identifiers

NCT05979883

GMROR2371

23-004732 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years at time of registration
• Receiving curative intent intensity modulated radiotherapy for head and neck primary cancer at the discretion of the treating medical doctor (MD)
• Provide written informed consent or allow legally authorized representative to consent on behalf of a participant
• Willing to return to enrolling institution for study follow-up visit

Exclusion criteria

• Incarcerated
• Unable to provide informed consent
• Prior Head and Neck (H&N) radiation therapy
• Planned radiation dosing LK<30 Gy or >76 Gy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

Arm A: Standard of care (SOC) treatment planning

Other group

Description:

Patients randomized to the SOC treatment planning arm will receive a treatment planning computed tomography (CT) scan followed by dosimetric planning with a medical dosimetrist; and the plan will be reviewed by a medical physicist and radiation oncologist. This is the current standard practice for all radiation oncology patients.

Treatment:

Radiation: Radiation Therapy Standard of Care (SOC)

Arm B: Machine Learning Assisted Planning (MLAP)

Active Comparator group

Description:

Patients randomized to the MLAP arm will receive a treatment planning scan followed by MLAP through the RapidPlan module produced by Varian. Of note, RapidPlan is an FDA cleared module with treatment planning being the approved usage for the program. The RapidPlan module has site specific treatment packages for different disease sites. These separate disease specific packages have different capabilities. For example, the Head and Neck package currently audits dosimetrist-generated plans for possible improvements. The MLAP arm of the trial will leverage the RapidPlan module's full capabilities upwards to the FDA-approved usage.

Treatment:

Radiation: Machine Learning Assisted Radiation (MLAP) RapidPlan