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| ID | Type | Description | Link |
|---|---|---|---|
| 23-004732 | Other Identifier | Mayo Clinic Institutional Review Board |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Standard of care (SOC) treatment planning | Other | 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. |
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| Arm B: Machine Learning Assisted Planning (MLAP) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Machine Learning Assisted Radiation (MLAP) RapidPlan | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in swallowing score | Will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck module (EORTC QLQ-H&N35). The EORTC QLQ-H&N35 is a 35-item questionnaire used to assess symptoms encountered specifically by patients with head and neck cancer. The H&N35 consists of 7 multiple-item scales (Pain, Swallowing, Senses, Speech, Social eating, Social contact, and Sexuality), in addition to 11 single items (e.g., Opening mouth, Sticky saliva, Dry mouth, etc.). Scores are combined into an overall score ranging from 0=Best to 100=Worst. 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). | Baseline (up to 30 days prior to treatment planning); up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physician-reported toxicities | Assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Toxicities 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). | Baseline; up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in quality of life scores | Quality of life scores will be compared between arms, 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel J. Ma, M.D. | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic in Florida |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Radiation Therapy Standard of Care (SOC) | Radiation | 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. |
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| 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. | Baseline; up to 6 months |
| 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. | Baseline; up to 6 months |
| Baseline; up to 6 months |
| Change in dose-volume histograms (DVHs) | 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). | Baseline; up to 6 months |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Mayo Clinic Health System in Albert Lea | Albert Lea | Minnesota | 56007 | United States |
| Mayo Clinic Health Systems-Mankato | Mankato | Minnesota | 56001 | United States |
| Mayo Clinic Health System-Eau Claire Clinic | Eau Claire | Wisconsin | 54701 | United States |
| Mayo Clinic Health System-Franciscan Healthcare | La Crosse | Wisconsin | 54601 | United States |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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