xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05979883</url>
    </required_header>
    <id_info>
      <org_study_id>GMROR2371</org_study_id>
      <secondary_id>23-004732</secondary_id>
      <nct_id>NCT05979883</nct_id>
    </id_info>
    <brief_title>Randomized Evaluation of Machine Learning Assisted Radiation Treatment Planning vs Standard Radiation Treatment Planning</brief_title>
    <official_title>A Randomized Evaluation of Machine Learning Assisted Radiation Treatment Planning Versus Standard Radiation Treatment Planning</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mayo Clinic</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to determine the magnitude of clinical benefit achieved through&#xD;
        machine learning assisted radiation treatment planning (MLAP) on post-treatment clinical&#xD;
        outcomes such as acute toxicity and patient reported outcomes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a randomized phase III trial to evaluate the effectiveness of MLAP compared to&#xD;
        Standard of Care. Patients will undergo a randomization procedure with a variable allocation&#xD;
        ratio where the first third of patients are randomized 3:1 in favor of SOC, the next third&#xD;
        randomized 1:1, and the last third randomized 1:3 in favor of MLAP. This is done to give&#xD;
        dosimetrists time to optimize the MLAP workflow. Since the treatment team may learn to&#xD;
        improve their treatment planning process in the SOC arm through interactions with RapidPlan,&#xD;
        as a sensitivity analysis, the primary and secondary goals will be re-analyzed including time&#xD;
        of registration as a moderator of the treatment effect.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 7, 2023</start_date>
    <completion_date type="Anticipated">December 2026</completion_date>
    <primary_completion_date type="Anticipated">November 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>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&amp;N35)</measure>
      <time_frame>Baseline; 6 months</time_frame>
      <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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in physician-reported toxicities as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0</measure>
      <time_frame>Baseline; 6 months</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in treatment plan quality metrics (PQMs) across treatment arms</measure>
      <time_frame>Baseline; 6 months</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in time to complete treatment planning</measure>
      <time_frame>Baseline; 6 months</time_frame>
      <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.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Difference in quality of life scores</measure>
      <time_frame>Baseline; 6 months</time_frame>
      <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&amp;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%.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in dose-volume histograms (DVHs)</measure>
      <time_frame>Baseline; 6 months</time_frame>
      <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.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">204</enrollment>
    <condition>Cancer Head Neck</condition>
    <condition>Cancer, Head</condition>
    <condition>Cancer Neck</condition>
    <arm_group>
      <arm_group_label>Arm A: Standard of care (SOC) treatment planning</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm B: Machine Learning Assisted Planning (MLAP)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Machine Learning Assisted Radiation (MLAP) RapidPlan</intervention_name>
      <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.</description>
      <arm_group_label>Arm B: Machine Learning Assisted Planning (MLAP)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Radiation Therapy Standard of Care (SOC)</intervention_name>
      <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.</description>
      <arm_group_label>Arm A: Standard of care (SOC) treatment planning</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years at time of registration&#xD;
  &#xD;
            -  Receiving curative intent intensity modulated radiotherapy for head and neck primary&#xD;
               cancer at the discretion of the treating medical doctor (MD)&#xD;
  &#xD;
            -  Provide written informed consent or allow legally authorized representative to consent&#xD;
               on behalf of a participant&#xD;
  &#xD;
            -  Willing to return to enrolling institution for study follow-up visit&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Incarcerated&#xD;
  &#xD;
            -  Unable to provide informed consent&#xD;
  &#xD;
            -  Prior Head and Neck (H&amp;N) radiation therapy&#xD;
  &#xD;
            -  Planned radiation dosing LK&lt;30 Gy or &gt;76 Gy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Daniel J. Ma, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic in Rochester</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Clinical Trials Referral Office</last_name>
      <phone>855-77 6-0015</phone>
      <email>mayocliniccancerstudies@mayo.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Christy Todd</last_name>
      <phone>507-293-2310</phone>
      <email>Todd.Christy@mayo.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Mayo Clinic in Arizona</name>
        <address>
          <city>Scottsdale</city>
          <state>Arizona</state>
          <zip>85259</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Clinical Trials Referral Office</last_name>
        <phone>855-776-0015</phone>
        <email>mayocliniccancerstudies@mayo.edu</email>
      </contact>
      <contact_backup>
        <last_name>Shawn Haren</last_name>
        <phone>480-342-6083</phone>
        <email>Haren.Shawn@mayo.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Samir H. Patel, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Mayo Clinic in Florida</name>
        <address>
          <city>Jacksonville</city>
          <state>Florida</state>
          <zip>32224</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Clinical Trials Referral Office</last_name>
        <phone>855-776-0015</phone>
        <email>mayocliniccancerstudies@mayo.edu</email>
      </contact>
      <contact_backup>
        <last_name>Caroline Pamboukas</last_name>
        <phone>904-953-2791</phone>
        <email>Pamboukas.Caroline@mayo.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Byron C. May, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Mayo Clinic Health System in Albert Lea</name>
        <address>
          <city>Albert Lea</city>
          <state>Minnesota</state>
          <zip>56007</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Clinical Trials Referral Office</last_name>
        <phone>855-776-0015</phone>
        <email>mayocliniccancerstudies@mayo.edu</email>
      </contact>
      <contact_backup>
        <last_name>Christy Todd</last_name>
        <phone>507-293-2310</phone>
        <email>Todd.Christy@mayo.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Timothy F. Kozelsky, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Mayo Clinic Health Systems-Mankato</name>
        <address>
          <city>Mankato</city>
          <state>Minnesota</state>
          <zip>56001</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Clinical Trials Referral Office</last_name>
        <phone>855-776-0015</phone>
        <email>mayocliniccancerstudies@mayo.edu</email>
      </contact>
      <contact_backup>
        <last_name>Christy Todd</last_name>
        <phone>507-293-2310</phone>
        <email>Todd.Christy@mayo.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Ron S. Smith, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Mayo Clinic Health System-Eau Claire Clinic</name>
        <address>
          <city>Eau Claire</city>
          <state>Wisconsin</state>
          <zip>54701</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Clinical Trials Referral Office</last_name>
        <phone>855-776-0015</phone>
        <email>mayocliniccancerstudies@mayo.edu</email>
      </contact>
      <contact_backup>
        <last_name>Christy Todd</last_name>
        <phone>507-293-2310</phone>
        <email>Todd.Christy@mayo.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Zachary C. Wilson, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Mayo Clinic Health System-Franciscan Healthcare</name>
        <address>
          <city>La Crosse</city>
          <state>Wisconsin</state>
          <zip>54601</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Clinical Trials Referral Office</last_name>
        <phone>855-776-0015</phone>
        <email>mayocliniccancerstudies@mayo.edu</email>
      </contact>
      <contact_backup>
        <last_name>Christy Todd</last_name>
        <phone>507-293-2310</phone>
        <email>Todd.Christy@mayo.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Abigail L. Stockham, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.mayo.edu/research/clinical-trials</url>
      <description>Mayo Clinic Clinical Trials</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mayo Clinic</investigator_affiliation>
      <investigator_full_name>Daniel J. Ma, M.D.</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>MLAP (Machine Learning Adaptive Planning)</keyword>
    <keyword>RapidPlan</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Head and Neck Neoplasms</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05979883
  org study id: GMROR2371
  secondary id: 23-004732
  nct id: NCT05979883
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  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.
  allocation: Randomized
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: 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
  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.
  measure: Change in physician-reported toxicities as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
  time frame: Baseline; 6 months
  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.
  measure: Difference in treatment plan quality metrics (PQMs) across treatment arms
  time frame: Baseline; 6 months
  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.
  measure: Difference in time to complete treatment planning
  time frame: Baseline; 6 months
  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.
  measure: Difference in quality of life scores
  time frame: Baseline; 6 months
  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%.
  measure: Change in dose-volume histograms (DVHs)
  time frame: Baseline; 6 months
  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.
  arm group label: Arm A: Standard of care (SOC) treatment planning
  arm group type: Other
  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 group label: Arm B: Machine Learning Assisted Planning (MLAP)
  arm group type: Active Comparator
  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: 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
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Daniel J. Ma, M.D.
  role: Principal Investigator
  affiliation: Mayo Clinic in Rochester
  last name: Clinical Trials Referral Office
  phone: 855-77 6-0015
  email: mayocliniccancerstudies@mayo.edu
  last name: Christy Todd
  phone: 507-293-2310
  email: Todd.Christy@mayo.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
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  status: Recruiting
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  status: Recruiting
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  investigator: 
  country: United States
  url: https://www.mayo.edu/research/clinical-trials
  description: Mayo Clinic Clinical Trials
  responsible party type: Principal Investigator
  investigator affiliation: Mayo Clinic
  investigator full name: Daniel J. Ma, M.D.
  investigator title: Principal Investigator
  mesh term: Head and Neck Neoplasms