Cancer Head Neck Clinical Trial
Official title:
A Randomized Evaluation of Machine Learning Assisted Radiation Treatment Planning Versus Standard Radiation Treatment Planning
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.
Status | Recruiting |
Enrollment | 204 |
Est. completion date | December 2026 |
Est. primary completion date | November 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Health System in Albert Lea | Albert Lea | Minnesota |
United States | Mayo Clinic Health System-Eau Claire Clinic | Eau Claire | Wisconsin |
United States | Mayo Clinic in Florida | Jacksonville | Florida |
United States | Mayo Clinic Health System-Franciscan Healthcare | La Crosse | Wisconsin |
United States | Mayo Clinic Health Systems-Mankato | Mankato | Minnesota |
United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Difference in quality of life scores | 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%. | Baseline; 6 months | |
Other | 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). 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. | Baseline; 6 months | |
Primary | 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. | Baseline; 6 months | |
Secondary | 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. | Baseline; 6 months | |
Secondary | 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. | Baseline; 6 months | |
Secondary | 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. | Baseline; 6 months |
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