Clinical trial NCT05979883: Randomized Evaluation of Machine Learning Assisted Radiation Treatment Planning Vs Standard Radiation Treatment Planning
Official title: A Randomized Evaluation of Machine Learning Assisted Radiation Treatment Planning Versus Standard Radiation Treatment Planning
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Head Neck
Cancer, Head
Cancer Neck
Keywords: MLAP (Machine Learning Adaptive Planning)
RapidPlan
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in scores on the Swallowing subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck module (EORTC QLQ-H&N35)
timeFrame: Baseline; 6 months
Secondary outcomes:
measure: Change in physician-reported toxicities as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
timeFrame: Baseline; 6 months
measure: Difference in treatment plan quality metrics (PQMs) across treatment arms
timeFrame: Baseline; 6 months
measure: Difference in time to complete treatment planning
timeFrame: Baseline; 6 months
Other outcomes:
measure: Difference in quality of life scores
timeFrame: Baseline; 6 months
measure: Change in dose-volume histograms (DVHs)
timeFrame: Baseline; 6 months
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Albert Lea
country: United States
facility: Mayo Clinic Health System in Albert Lea
state: Minnesota
city: Mankato
country: United States
facility: Mayo Clinic Health Systems-Mankato
state: Minnesota
city: Eau Claire
country: United States
facility: Mayo Clinic Health System-Eau Claire Clinic
state: Wisconsin
city: La Crosse
country: United States
facility: Mayo Clinic Health System-Franciscan Healthcare
state: Wisconsin
Study officials:
affiliation: Mayo Clinic in Rochester
name: Daniel J. Ma, M.D.
role: PRINCIPAL_INVESTIGATOR
References: