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

NCT05979883 | Completed DMC FDA Device

• 2 other identifiers: GMROR237123-004732
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Cancer Neck; Cancer Head Neck; Cancer, Head

Keywords

MLAP (Machine Learning Adaptive Planning); RapidPlan

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline (up to 30 days prior to treatment planning); up to 6 months

Secondary Outcomes (3)

• Change in physician-reported toxicities

  Baseline; up to 6 months

• Difference in treatment plan quality metrics (PQMs) across treatment arms

  Baseline; up to 6 months

• Difference in time to complete treatment planning

  Baseline; up to 6 months

Other Outcomes (2)

• Difference in quality of life scores

  Baseline; up to 6 months

• Change in dose-volume histograms (DVHs)

  Baseline; up to 6 months

Study Arms (2)

Arm A: Standard of care (SOC) treatment planning

OTHER

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.

Radiation: Radiation Therapy Standard of Care (SOC)

Arm B: Machine Learning Assisted Planning (MLAP)

ACTIVE COMPARATOR

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.

Radiation: Machine Learning Assisted Radiation (MLAP) RapidPlan

Interventions

Machine Learning Assisted Radiation (MLAP) RapidPlan RADIATION

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.

Arm B: Machine Learning Assisted Planning (MLAP)

Radiation Therapy Standard of Care (SOC) RADIATION

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.

Arm A: Standard of care (SOC) treatment planning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (6)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, 56007, United States

Location

Mayo Clinic Health Systems-Mankato

Mankato, Minnesota, 56001, United States

Location

Mayo Clinic Health System-Eau Claire Clinic

Eau Claire, Wisconsin, 54701, United States

Location

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, 54601, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Daniel J. Ma, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 7, 2023
• Study Start: August 7, 2023
• Primary Completion: October 29, 2025
• Study Completion: October 29, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

US (6)