<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/NCT03270072</url>
  </required_header>
  <id_info>
    <org_study_id>17-031</org_study_id>
    <nct_id>NCT03270072</nct_id>
  </id_info>
  <brief_title>The Differential Impact of Proton Beam Irradiation Versus Conventional Radiation on Organs-at-risk in Stage II-III Breast Cancer Patients</brief_title>
  <official_title>The Differential Impact of Proton Beam Irradiation Versus Conventional Radiation on Organs-at-risk in Stage II-III Breast Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to serve as a correlative study for patients enrolled on the&#xD;
      RadCOMP trial (NCT02603341), a randomized phase III study of stage II and III breast cancer&#xD;
      patients treated with either conventional photon radiation or proton beam radiation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 26, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2027</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Global Longitudinal Strain (GLS)</measure>
    <time_frame>Baseline, 6 Months</time_frame>
    <description>Comparison of the change in GLS between conventional radiation and proton beam radiation groups. Participants who decrease their GLS by at least 2% 6-8 months following radiation therapy will be considered to demonstrate a significant decrement in GLS.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Left Ventricular Ejection Fraction (LVEF) Using Echocardiography</measure>
    <time_frame>Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment</time_frame>
    <description>Comparison of the change in LVEF between conventional radiation and proton beam radiation groups. Reduced cardiac function is defined as an ejection fraction &lt;50%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiation-induced Lung Parenchymal Changes Using CT Imaging</measure>
    <time_frame>Baseline, 3,6,12, months post treatment</time_frame>
    <description>Radiation-induced lung parenchymal changes will be assess with non-contrast enhanced computerized tomography (CT) scans and incidence will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test. Among patients who do not have any changes detected, death and disease progression will be considered as competing risks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Thyroid Dysfunction</measure>
    <time_frame>Baseline, end of treatment (approximately 10 weeks), then 12, 24, 36, and 60 months post treatment</time_frame>
    <description>Incidence of thyroid insufficiency will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test. In the absence of thyroid dysfunction, death and disease progression will be considered as competing risks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Ipsilateral Arm Lymphedema</measure>
    <time_frame>Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment</time_frame>
    <description>Incidence of ipsilateral arm lymphedema will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of Ipsilateral Arm Lymphedema</measure>
    <time_frame>Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment</time_frame>
    <description>Serial arm measurements may be analyzed using mixed effects model to compare the severity of ipsilateral arm lymphedema over time between the radiation groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ipsilateral Breast/Chest Wall Cosmesis</measure>
    <time_frame>Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment</time_frame>
    <description>Breast cosmesis will be assessed with characteristics graded on a four-point scale. Assessments will be performed by a trained nurse/nurse practitioner using the European Organization for Research and Treatment of Cancer (EORTC) Cosmetic Rating System for Breast Cancer. Incidence of adverse cosmesis (2=fair or 3=poor score) will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test. Among patients without adverse breast cosmesis, death and disease progression will be considered as competing risks.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Breast Cancer Stage II</condition>
  <condition>Breast Cancer Stage III</condition>
  <arm_group>
    <arm_group_label>Photon Therapy</arm_group_label>
    <description>The patients being treated on the Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial (NCT02603341) at Massachusetts General Hospital that were randomized to receive photon therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Proton Therapy</arm_group_label>
    <description>The patients being treated on the Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial (NCT02603341) at Massachusetts General Hospital that were randomized to receive proton therapy</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients enrolled at Massachusetts General Hospital on the Radiation Therapy Oncology Group&#xD;
        (RTOG) Trial 3510 (Pragmatic Phase III Randomized Trial of Proton vs Photon Therapy for&#xD;
        Patients with Non-Metastatic Breast Cancer Receiving Comprehensive Nodal Radiation: A&#xD;
        Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial). (NCT02603341).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible for and scheduled to receive radiation therapy on Radiation Therapy Oncology&#xD;
             Group (RTOG) Trial 3510 (Pragmatic Phase III Randomized Trial of Proton vs Photon&#xD;
             Therapy for Patients with Non-Metastatic Breast Cancer Receiving Comprehensive Nodal&#xD;
             Radiation: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial).&#xD;
             (NCT02603341)&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a study-specific written informed&#xD;
             consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  There are no exclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachel Jimenez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rachel Jimenez, MD</last_name>
    <phone>617-726-7559</phone>
    <email>RBJIMENEZ@PARTNERS.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rachel Jimenez, MD</last_name>
      <phone>617-726-7559</phone>
      <email>RBJIMENEZ@Partners.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 13, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>September 15, 2023</last_update_submitted>
  <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Rachel Beth Jimenez</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03270072
org study id: 17-031
nct id: NCT03270072
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of the study is to serve as a correlative study for patients enrolled on the
      RadCOMP trial (NCT02603341), a randomized phase III study of stage II and III breast cancer
      patients treated with either conventional photon radiation or proton beam radiation
observational model: Cohort
time perspective: Prospective
measure: Change in Global Longitudinal Strain (GLS)
time frame: Baseline, 6 Months
description: Comparison of the change in GLS between conventional radiation and proton beam radiation groups. Participants who decrease their GLS by at least 2% 6-8 months following radiation therapy will be considered to demonstrate a significant decrement in GLS.
measure: Change in Left Ventricular Ejection Fraction (LVEF) Using Echocardiography
time frame: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment
description: Comparison of the change in LVEF between conventional radiation and proton beam radiation groups. Reduced cardiac function is defined as an ejection fraction <50%.
measure: Radiation-induced Lung Parenchymal Changes Using CT Imaging
time frame: Baseline, 3,6,12, months post treatment
description: Radiation-induced lung parenchymal changes will be assess with non-contrast enhanced computerized tomography (CT) scans and incidence will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test. Among patients who do not have any changes detected, death and disease progression will be considered as competing risks.
measure: Incidence of Thyroid Dysfunction
time frame: Baseline, end of treatment (approximately 10 weeks), then 12, 24, 36, and 60 months post treatment
description: Incidence of thyroid insufficiency will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test. In the absence of thyroid dysfunction, death and disease progression will be considered as competing risks.
measure: Incidence of Ipsilateral Arm Lymphedema
time frame: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment
description: Incidence of ipsilateral arm lymphedema will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test.
measure: Severity of Ipsilateral Arm Lymphedema
time frame: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment
description: Serial arm measurements may be analyzed using mixed effects model to compare the severity of ipsilateral arm lymphedema over time between the radiation groups.
measure: Ipsilateral Breast/Chest Wall Cosmesis
time frame: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment
description: Breast cosmesis will be assessed with characteristics graded on a four-point scale. Assessments will be performed by a trained nurse/nurse practitioner using the European Organization for Research and Treatment of Cancer (EORTC) Cosmetic Rating System for Breast Cancer. Incidence of adverse cosmesis (2=fair or 3=poor score) will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test. Among patients without adverse breast cosmesis, death and disease progression will be considered as competing risks.
arm group label: Photon Therapy
description: The patients being treated on the Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial (NCT02603341) at Massachusetts General Hospital that were randomized to receive photon therapy.
arm group label: Proton Therapy
description: The patients being treated on the Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial (NCT02603341) at Massachusetts General Hospital that were randomized to receive proton therapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Rachel Jimenez, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Rachel Jimenez, MD
phone: 617-726-7559
email: RBJIMENEZ@PARTNERS.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Rachel Beth Jimenez
investigator title: Principal Investigator
mesh term: Breast Neoplasms