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

Not Applicable

Active, not recruiting

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

• Registration Number: NCT05979883
• Lead Sponsor: Mayo Clinic

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.

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.

Study Timeline

• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-07-31
• Study Start: 2023-08-07
• Study First Posted: 2023-08-07
• Status Verified: 2025-07
• Last Update Submitted: 2025-08-12
• Last Update Posted: 2025-08-15
• Primary Completion: 2025-12-16
• Study Completion: 2025-12-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 204

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in swallowing score	Baseline (up to 30 days prior to treatment planning); up to 6 months	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).

Secondary Outcome Measures

Name	Time	Method
Change in physician-reported toxicities	Baseline; up to 6 months	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).
Difference in treatment plan quality metrics (PQMs) across treatment arms	Baseline; up to 6 months	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.
Difference in time to complete treatment planning	Baseline; up to 6 months	Treatment planning time is defined as the time in minutes from the end of physician contouring to the end of physician plan approval.

Trial Locations

Locations (6)

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

Mayo Clinic Health System-Eau Claire Clinic; 🇺🇸 Eau Claire, Wisconsin, United States

Mayo Clinic Health System-Franciscan Healthcare; 🇺🇸 La Crosse, Wisconsin, United States