Back to resultsRandomized Evaluation of Machine Learning Assisted Radiation Treatment Planning vs Standard Radiation Treatment Planning
Primary Purpose
Cancer Head Neck, Cancer, Head, Cancer Neck
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Machine Learning Assisted Radiation (MLAP) RapidPlan
Radiation Therapy Standard of Care (SOC)
Sponsored by
About this trial
This is an interventional treatment trial for Cancer Head Neck focused on measuring MLAP (Machine Learning Adaptive Planning), RapidPlan
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
Sites / Locations
- Mayo Clinic in ArizonaRecruiting
- Mayo Clinic in FloridaRecruiting
- Mayo Clinic Health System in Albert LeaRecruiting
- Mayo Clinic Health Systems-MankatoRecruiting
- Mayo Clinic Health System-Eau Claire ClinicRecruiting
- Mayo Clinic Health System-Franciscan HealthcareRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Arm A: Standard of care (SOC) treatment planning
Arm B: Machine Learning Assisted Planning (MLAP)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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)
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). An ANCOVA model with the baseline Swallowing score as a covariate will be used to test for a significant difference between the two treatment arms at the 5% alpha level. The analysis will be modified intent-to-treat. Specifically, all patients meeting eligibility criteria who have signed a consent form, were randomized, started radiation treatment, and have a scale score within the time window of +/-30 days from 3 months post-radiotherapy will be considered evaluable for this endpoint.
Secondary Outcome Measures
Change in physician-reported toxicities as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
CTCAES 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). Physician-reported toxicities is defined as the dysphasia, dry mouth, and oral pain items from the CTCAE v5.0. The items will be analyzed individually and as a composite. Further, there will be two sets of comparisons: Grade 3+ versus not and Grade 2+ versus not. Comparisons between treatment arms will be made using a Chi-square test with an alpha level of 5%. The analyses will be modified intent-to-treat. Specifically, all patients meeting eligibility criteria who have signed a consent form, were randomized, started radiation treatment, and have toxicity scores within the time window of +/-30 days from 3 months post-radiotherapy will be considered evaluable for this endpoint.
Difference in treatment plan quality metrics (PQMs) across treatment arms
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 using a two-sided Student's t-test (or Wilcoxon Rank-Sum test for non-normal data) with an alpha level of 5%. All eligible patients who went through treatment planning should be evaluable for this endpoint. Sensitivity analyses will be conducted for all secondary endpoints where the analyses will be repeated including the interaction of time of registration and treatment group and subgroup analyses for the 3 different allocation ratios will be conducted.
Difference in time to complete treatment planning
Treatment planning time is defined as the time in minutes from the end of physician contouring to the end of physician plan approval. Comparisons between treatment arms will be made using a two-sided Student's t-test (or Wilcoxon Rank-Sum test for non-normal data) with an alpha level of 5%. All eligible patients who went through treatment planning should be evaluable for this endpoint. Sensitivity analyses will be conducted for all secondary endpoints where the analyses will be repeated including the interaction of time of registration and treatment group and subgroup analyses for the 3 different allocation ratios will be conducted.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05979883
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2023 (Actual)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Head Neck, Cancer, Head, Cancer Neck
Keywords
MLAP (Machine Learning Adaptive Planning), RapidPlan
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Standard of care (SOC) treatment planning
Arm Type
Other
Arm Description
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.
Arm Title
Arm B: Machine Learning Assisted Planning (MLAP)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Machine Learning Assisted Radiation (MLAP) RapidPlan
Intervention 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.
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy Standard of Care (SOC)
Intervention 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.
Primary Outcome Measure Information:
Title
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)
Description
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). An ANCOVA model with the baseline Swallowing score as a covariate will be used to test for a significant difference between the two treatment arms at the 5% alpha level. The analysis will be modified intent-to-treat. Specifically, all patients meeting eligibility criteria who have signed a consent form, were randomized, started radiation treatment, and have a scale score within the time window of +/-30 days from 3 months post-radiotherapy will be considered evaluable for this endpoint.
Time Frame
Baseline; 6 months
Secondary Outcome Measure Information:
Title
Change in physician-reported toxicities as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Description
CTCAES 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). Physician-reported toxicities is defined as the dysphasia, dry mouth, and oral pain items from the CTCAE v5.0. The items will be analyzed individually and as a composite. Further, there will be two sets of comparisons: Grade 3+ versus not and Grade 2+ versus not. Comparisons between treatment arms will be made using a Chi-square test with an alpha level of 5%. The analyses will be modified intent-to-treat. Specifically, all patients meeting eligibility criteria who have signed a consent form, were randomized, started radiation treatment, and have toxicity scores within the time window of +/-30 days from 3 months post-radiotherapy will be considered evaluable for this endpoint.
Time Frame
Baseline; 6 months
Title
Difference in treatment plan quality metrics (PQMs) across treatment arms
Description
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 using a two-sided Student's t-test (or Wilcoxon Rank-Sum test for non-normal data) with an alpha level of 5%. All eligible patients who went through treatment planning should be evaluable for this endpoint. Sensitivity analyses will be conducted for all secondary endpoints where the analyses will be repeated including the interaction of time of registration and treatment group and subgroup analyses for the 3 different allocation ratios will be conducted.
Time Frame
Baseline; 6 months
Title
Difference in time to complete treatment planning
Description
Treatment planning time is defined as the time in minutes from the end of physician contouring to the end of physician plan approval. Comparisons between treatment arms will be made using a two-sided Student's t-test (or Wilcoxon Rank-Sum test for non-normal data) with an alpha level of 5%. All eligible patients who went through treatment planning should be evaluable for this endpoint. Sensitivity analyses will be conducted for all secondary endpoints where the analyses will be repeated including the interaction of time of registration and treatment group and subgroup analyses for the 3 different allocation ratios will be conducted.
Time Frame
Baseline; 6 months
Other Pre-specified Outcome Measures:
Title
Difference in quality of life scores
Description
Compare quality of life as measured by the 6 remaining subscales and 11 single item scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck module (EORTC QLQ-H&N35). EORTC scores 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). Comparisons between treatment arms will be made using an ANCOVA model with the baseline Patient Reported Outcome (PRO) score included as a covariate and tested at an alpha level of 5%.
Time Frame
Baseline; 6 months
Title
Change in dose-volume histograms (DVHs)
Description
DVH statistics will be compared between treatment arms within cohorts of planned radiation dose (30-54 Gy vs. 54-66 Gy vs. 66-76 Gy) and laterality (bilateral vs. unilateral). Comparisons between treatment arms will be made using a two-sided Student's t-test (or Wilcoxon Rank-Sum test for non-normal data) with an alpha level of 5%. All eligible patients who went through treatment planning should be evaluable for this endpoint.
Time Frame
Baseline; 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials Referral Office
Phone
855-77 6-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Christy Todd
Phone
507-293-2310
Email
Todd.Christy@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J. Ma, M.D.
Organizational Affiliation
Mayo Clinic in Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Shawn Haren
Phone
480-342-6083
Email
Haren.Shawn@mayo.edu
First Name & Middle Initial & Last Name & Degree
Samir H. Patel, M.D.
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Caroline Pamboukas
Phone
904-953-2791
Email
Pamboukas.Caroline@mayo.edu
First Name & Middle Initial & Last Name & Degree
Byron C. May, M.D.
Facility Name
Mayo Clinic Health System in Albert Lea
City
Albert Lea
State/Province
Minnesota
ZIP/Postal Code
56007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Christy Todd
Phone
507-293-2310
Email
Todd.Christy@mayo.edu
First Name & Middle Initial & Last Name & Degree
Timothy F. Kozelsky, M.D.
Facility Name
Mayo Clinic Health Systems-Mankato
City
Mankato
State/Province
Minnesota
ZIP/Postal Code
56001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Christy Todd
Phone
507-293-2310
Email
Todd.Christy@mayo.edu
First Name & Middle Initial & Last Name & Degree
Ron S. Smith, M.D.
Facility Name
Mayo Clinic Health System-Eau Claire Clinic
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Christy Todd
Phone
507-293-2310
Email
Todd.Christy@mayo.edu
First Name & Middle Initial & Last Name & Degree
Zachary C. Wilson, M.D.
Facility Name
Mayo Clinic Health System-Franciscan Healthcare
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Christy Todd
Phone
507-293-2310
Email
Todd.Christy@mayo.edu
First Name & Middle Initial & Last Name & Degree
Abigail L. Stockham, M.D.
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Randomized Evaluation of Machine Learning Assisted Radiation Treatment Planning vs Standard Radiation Treatment Planning
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