Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

Mayo Clinic

Conditions:

Cancer Head Neck

Cancer, Head

Eligibility:

All Genders

18+ years

Phase:

NA

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 a...

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 firs...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

August 7 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 16 2025

Estimated Enrollment :

204 Patients enrolled

Trial Details

Trial ID

NCT05979883

Start Date

August 7 2023

End Date

December 16 2025

Last Update

August 15 2025

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Mayo Clinic in Arizona

Scottsdale, Arizona, United States, 85259

2

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224

3

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, United States, 56007

4

Mayo Clinic Health Systems-Mankato

Mankato, Minnesota, United States, 56001