Trial Title:
Randomized Evaluation of Machine Learning Assisted Radiation Treatment Planning Vs Standard Radiation Treatment Planning
NCT ID:
NCT05979883
Condition:
Cancer Head Neck
Cancer, Head
Cancer Neck
Conditions: Official terms:
Head and Neck Neoplasms
Conditions: Keywords:
MLAP (Machine Learning Adaptive Planning)
RapidPlan
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Machine Learning Assisted Radiation (MLAP) RapidPlan
Description:
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 group label:
Arm B: Machine Learning Assisted Planning (MLAP)
Intervention type:
Radiation
Intervention name:
Radiation Therapy Standard of Care (SOC)
Description:
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 group label:
Arm A: Standard of care (SOC) treatment planning
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Arizona
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Shawn Haren
Phone:
480-342-6083
Email:
Haren.Shawn@mayo.edu
Contact backup:
Last name:
Samir H. Patel, M.D.
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Caroline Pamboukas
Phone:
904-953-2791
Email:
Pamboukas.Caroline@mayo.edu
Contact backup:
Last name:
Byron C. May, M.D.
Facility:
Name:
Mayo Clinic Health System in Albert Lea
Address:
City:
Albert Lea
Zip:
56007
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Christy Todd
Phone:
507-293-2310
Email:
Todd.Christy@mayo.edu
Contact backup:
Last name:
Timothy F. Kozelsky, M.D.
Facility:
Name:
Mayo Clinic Health Systems-Mankato
Address:
City:
Mankato
Zip:
56001
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Christy Todd
Phone:
507-293-2310
Email:
Todd.Christy@mayo.edu
Contact backup:
Last name:
Ron S. Smith, M.D.
Facility:
Name:
Mayo Clinic Health System-Eau Claire Clinic
Address:
City:
Eau Claire
Zip:
54701
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Christy Todd
Phone:
507-293-2310
Email:
Todd.Christy@mayo.edu
Contact backup:
Last name:
Zachary C. Wilson, M.D.
Facility:
Name:
Mayo Clinic Health System-Franciscan Healthcare
Address:
City:
La Crosse
Zip:
54601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Christy Todd
Phone:
507-293-2310
Email:
Todd.Christy@mayo.edu
Contact backup:
Last name:
Abigail L. Stockham, M.D.
Start date:
August 7, 2023
Completion date:
December 2026
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05979883
https://www.mayo.edu/research/clinical-trials
