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

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ClinicalTrials.gov Identifier: NCT05979883

Recruitment Status : Recruiting

First Posted : August 7, 2023

Last Update Posted : August 14, 2023

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Sponsor:

Information provided by (Responsible Party):

Daniel J. Ma, M.D., Mayo Clinic

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.

Condition or disease	Intervention/treatment	Phase
Cancer Head Neck Cancer, Head Cancer Neck	Radiation: Machine Learning Assisted Radiation (MLAP) RapidPlan Radiation: Radiation Therapy Standard of Care (SOC)	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	204 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Randomized Evaluation of Machine Learning Assisted Radiation Treatment Planning Versus Standard Radiation Treatment Planning
Actual Study Start Date :	August 7, 2023
Estimated Primary Completion Date :	November 2026
Estimated Study Completion Date :	December 2026

Arms and Interventions

Arm	Intervention/treatment
Arm A: Standard of care (SOC) treatment planning 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.	Radiation: Radiation Therapy Standard of Care (SOC) 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.
Active Comparator: Arm B: Machine Learning Assisted Planning (MLAP) 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.	Radiation: Machine Learning Assisted Radiation (MLAP) RapidPlan 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

Intervention/treatment

Arm A: Standard of care (SOC) treatment planning

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.

Radiation: Radiation Therapy Standard of Care (SOC)

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.

Active Comparator: Arm B: Machine Learning Assisted Planning (MLAP)

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.

Radiation: Machine Learning Assisted Radiation (MLAP) RapidPlan

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.

Outcome Measures

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) [ Time Frame: Baseline; 6 months ]
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 [ Time Frame: Baseline; 6 months ]
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 [ Time Frame: Baseline; 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 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 [ Time Frame: Baseline; 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. 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.

Other Outcome Measures:

Difference in quality of life scores [ Time Frame: Baseline; 6 months ]
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%.
Change in dose-volume histograms (DVHs) [ Time Frame: Baseline; 6 months ]
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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05979883

Contacts

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Contact: Clinical Trials Referral Office	855-77 6-0015	mayocliniccancerstudies@mayo.edu
Contact: Christy Todd	507-293-2310	Todd.Christy@mayo.edu

Locations

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United States, Arizona
Mayo Clinic in Arizona	Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Clinical Trials Referral Office 855-776-0015 mayocliniccancerstudies@mayo.edu
Contact: Shawn Haren 480-342-6083 Haren.Shawn@mayo.edu
Principal Investigator: Samir H. Patel, M.D.
United States, Florida
Mayo Clinic in Florida	Recruiting
Jacksonville, Florida, United States, 32224
Contact: Clinical Trials Referral Office 855-776-0015 mayocliniccancerstudies@mayo.edu
Contact: Caroline Pamboukas 904-953-2791 Pamboukas.Caroline@mayo.edu
Principal Investigator: Byron C. May, M.D.
United States, Minnesota
Mayo Clinic Health System in Albert Lea	Recruiting
Albert Lea, Minnesota, United States, 56007
Contact: Clinical Trials Referral Office 855-776-0015 mayocliniccancerstudies@mayo.edu
Contact: Christy Todd 507-293-2310 Todd.Christy@mayo.edu
Principal Investigator: Timothy F. Kozelsky, M.D.
Mayo Clinic Health Systems-Mankato	Recruiting
Mankato, Minnesota, United States, 56001
Contact: Clinical Trials Referral Office 855-776-0015 mayocliniccancerstudies@mayo.edu
Contact: Christy Todd 507-293-2310 Todd.Christy@mayo.edu
Principal Investigator: Ron S. Smith, M.D.
United States, Wisconsin
Mayo Clinic Health System-Eau Claire Clinic	Recruiting
Eau Claire, Wisconsin, United States, 54701
Contact: Clinical Trials Referral Office 855-776-0015 mayocliniccancerstudies@mayo.edu
Contact: Christy Todd 507-293-2310 Todd.Christy@mayo.edu
Principal Investigator: Zachary C. Wilson, M.D.
Mayo Clinic Health System-Franciscan Healthcare	Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Clinical Trials Referral Office 855-776-0015 mayocliniccancerstudies@mayo.edu
Contact: Christy Todd 507-293-2310 Todd.Christy@mayo.edu
Principal Investigator: Abigail L. Stockham, M.D.

Sponsors and Collaborators

Mayo Clinic

Investigators

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Principal Investigator:	Daniel J. Ma, M.D.	Mayo Clinic in Rochester

More Information

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Responsible Party:	Daniel J. Ma, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT05979883
Other Study ID Numbers:	GMROR2371 23-004732 ( Other Identifier: Mayo Clinic Institutional Review Board )
First Posted:	August 7, 2023 Key Record Dates
Last Update Posted:	August 14, 2023
Last Verified:	August 2023

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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

Keywords provided by Daniel J. Ma, M.D., Mayo Clinic:


MLAP (Machine Learning Adaptive Planning) RapidPlan

Additional relevant MeSH terms:

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Head and Neck Neoplasms Neoplasms by Site Neoplasms

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