<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/NCT03037723</url>
  </required_header>
  <id_info>
    <org_study_id>496516</org_study_id>
    <nct_id>NCT03037723</nct_id>
  </id_info>
  <brief_title>Prone Whole-Breast RadiationTherapy Versus Supine Whole-Breast Radiation Therapy Imaging</brief_title>
  <official_title>Prospective Trial of Prone Whole-Breast RadiationTherapy Versus Supine Whole-Breast Radiation Therapy With and Without Respiratory Gating, a Dosimetric Comparison</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State University of New York - Upstate Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>State University of New York - Upstate Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Radiation therapy to the breast has remained a standard practice for breast conserving&#xD;
      therapy. Because of the location of the heart and lungs when patients are positioned face-up,&#xD;
      whole breast radiation therapy has been reported to increase the risk of damage to the heart&#xD;
      a few years after treatment until at least 20 years after exposure, and may affect&#xD;
      cardiovascular mortality. Also, patients receiving whole breast radiation therapy are at an&#xD;
      increased risk for development of secondary lung malignancies. Recent studies have&#xD;
      demonstrated a significant reduction in dose to the heart and lungs when treated in the&#xD;
      face-down position. Similarly, correcting for the movement of breathing (respiratory gating)&#xD;
      in the face-up position has also become an available option for reducing unwanted dose to the&#xD;
      heart and lungs, particularly in left sided breast cancers. No study to date has compared&#xD;
      these newer organ-sparing techniques head-to-head for early stage breast cancer.&#xD;
&#xD;
      It is institutional policy to perform CT simulation in left-sided breast cancer patients with&#xD;
      and without the respiratory gating (this is one CT scan), in the face-up position. It is also&#xD;
      standard of care to perform the face-down CT simulation in large breasted women. Both of&#xD;
      these simulations are meant to reduce the exposure of the heart and lungs to radiation.&#xD;
&#xD;
      In this study, all left-sided breast cancer patients that consent will receive face-up CT&#xD;
      simulation with and without gating AND face-down CT simulation, regardless of breast size;&#xD;
      thus, each patient is their own control.&#xD;
&#xD;
      The treating physician will determine which of the two simulations, if any, offers better&#xD;
      protection to each patients' heart and lungs. Two dosimetrists will be required to&#xD;
      independently verify planned dosimetry with all treatment setups. Treatment will be planned&#xD;
      in standard fashion using the best of the two plans.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Radiation therapy to the breast has remained a standard practice for breast conserving&#xD;
      therapy. Because of the location of the heart and lungs when patients are positioned face-up,&#xD;
      whole breast radiation therapy has been reported to increase the risk of damage to the heart&#xD;
      a few years after treatment until at least 20 years after exposure, and may affect&#xD;
      cardiovascular mortality. Also, patients receiving whole breast radiation therapy are at an&#xD;
      increased risk for development of secondary lung malignancies. Recent studies have&#xD;
      demonstrated a significant reduction in dose to the heart and lungs when treated in the&#xD;
      face-down position. Similarly, correcting for the movement of breathing (respiratory gating)&#xD;
      in the face-up position has also become an available option for reducing unwanted dose to the&#xD;
      heart and lungs, particularly in left sided breast cancers. No study to date has compared&#xD;
      these newer organ-sparing techniques head-to-head for early stage breast cancer.&#xD;
&#xD;
      It is institutional policy to perform CT simulation in left-sided breast cancer patients with&#xD;
      and without the respiratory gating (this is one CT scan), in the face-up position. It is also&#xD;
      standard of care to perform the face-down CT simulation in large breasted women. Both of&#xD;
      these simulations are meant to reduce the exposure of the heart and lungs to radiation. In&#xD;
      this study, all left-sided breast cancer patients that consent will receive face-up CT&#xD;
      simulation with and without gating AND face-down CT simulation, regardless of breast size;&#xD;
      thus, each patient is their own control.&#xD;
&#xD;
      The treating physician will determine which of the two simulations, if any, offers better&#xD;
      protection to each patients' heart and lungs. Two dosimetrists will be required to&#xD;
      independently verify planned dosimetry with all treatment setups. Treatment will be planned&#xD;
      in standard fashion using the best of the two plans.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">December 2020</completion_date>
  <primary_completion_date type="Actual">December 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>mean heart dose</measure>
    <time_frame>immediate</time_frame>
    <description>dosimetric parameter</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Breast Cancer, Respiratory Gating, Prone</condition>
  <arm_group>
    <arm_group_label>Prone/Supine Simulation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>It is institutional policy to perform CT simulation in left-sided breast cancer patients with and without the respiratory gating (this is one CT scan), in the face-up position. It is also standard of care to perform the face-down CT simulation in large breasted women. Both of these simulations are meant to reduce the exposure of the heart and lungs to radiation. In this study, all left-sided breast cancer patients that consent will receive face-up CT simulation with and without gating AND face-down CT simulation, regardless of breast size; thus, each patient is their own control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CT simulation</intervention_name>
    <arm_group_label>Prone/Supine Simulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stage 0-IIA left, breast cancer,&#xD;
&#xD;
          -  After lumpectomy or segmental mastectomy,&#xD;
&#xD;
          -  With negative surgical margins&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Right breast cancer&#xD;
&#xD;
          -  Positive surgical margins&#xD;
&#xD;
          -  Stage 2B or higher&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>SUNY Upstate Medical University</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Darby SC, McGale P, Taylor CW, Peto R. Long-term mortality from heart disease and lung cancer after radiotherapy for early breast cancer: prospective cohort study of about 300,000 women in US SEER cancer registries. Lancet Oncol. 2005 Aug;6(8):557-65. doi: 10.1016/S1470-2045(05)70251-5.</citation>
    <PMID>16054566</PMID>
  </reference>
  <reference>
    <citation>Darby SC, Ewertz M, McGale P, Bennet AM, Blom-Goldman U, Bronnum D, Correa C, Cutter D, Gagliardi G, Gigante B, Jensen MB, Nisbet A, Peto R, Rahimi K, Taylor C, Hall P. Risk of ischemic heart disease in women after radiotherapy for breast cancer. N Engl J Med. 2013 Mar 14;368(11):987-98. doi: 10.1056/NEJMoa1209825.</citation>
    <PMID>23484825</PMID>
  </reference>
  <reference>
    <citation>Deutsch M, Land SR, Begovic M, Wieand HS, Wolmark N, Fisher B. The incidence of lung carcinoma after surgery for breast carcinoma with and without postoperative radiotherapy. Results of National Surgical Adjuvant Breast and Bowel Project (NSABP) clinical trials B-04 and B-06. Cancer. 2003 Oct 1;98(7):1362-8. doi: 10.1002/cncr.11655.</citation>
    <PMID>14508821</PMID>
  </reference>
  <reference>
    <citation>Ng J, Shuryak I, Xu Y, Clifford Chao KS, Brenner DJ, Burri RJ. Predicting the risk of secondary lung malignancies associated with whole-breast radiation therapy. Int J Radiat Oncol Biol Phys. 2012 Jul 15;83(4):1101-6. doi: 10.1016/j.ijrobp.2011.09.052. Epub 2012 Jan 13.</citation>
    <PMID>22245205</PMID>
  </reference>
  <reference>
    <citation>Lymberis SC, deWyngaert JK, Parhar P, Chhabra AM, Fenton-Kerimian M, Chang J, Hochman T, Guth A, Roses D, Goldberg JD, Formenti SC. Prospective assessment of optimal individual position (prone versus supine) for breast radiotherapy: volumetric and dosimetric correlations in 100 patients. Int J Radiat Oncol Biol Phys. 2012 Nov 15;84(4):902-9. doi: 10.1016/j.ijrobp.2012.01.040. Epub 2012 Apr 9.</citation>
    <PMID>22494590</PMID>
  </reference>
  <reference>
    <citation>Qi XS, Hu A, Wang K, Newman F, Crosby M, Hu B, White J, Li XA. Respiration induced heart motion and indications of gated delivery for left-sided breast irradiation. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):1605-11. doi: 10.1016/j.ijrobp.2011.01.042. Epub 2011 Apr 12.</citation>
    <PMID>21489710</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>State University of New York - Upstate Medical University</investigator_affiliation>
    <investigator_full_name>Anna Shapiro</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03037723
org study id: 496516
nct id: NCT03037723
lead sponsor: 
has dmc: No
Radiation therapy to the breast has remained a standard practice for breast conserving
      therapy. Because of the location of the heart and lungs when patients are positioned face-up,
      whole breast radiation therapy has been reported to increase the risk of damage to the heart
      a few years after treatment until at least 20 years after exposure, and may affect
      cardiovascular mortality. Also, patients receiving whole breast radiation therapy are at an
      increased risk for development of secondary lung malignancies. Recent studies have
      demonstrated a significant reduction in dose to the heart and lungs when treated in the
      face-down position. Similarly, correcting for the movement of breathing (respiratory gating)
      in the face-up position has also become an available option for reducing unwanted dose to the
      heart and lungs, particularly in left sided breast cancers. No study to date has compared
      these newer organ-sparing techniques head-to-head for early stage breast cancer.

      It is institutional policy to perform CT simulation in left-sided breast cancer patients with
      and without the respiratory gating (this is one CT scan), in the face-up position. It is also
      standard of care to perform the face-down CT simulation in large breasted women. Both of
      these simulations are meant to reduce the exposure of the heart and lungs to radiation.

      In this study, all left-sided breast cancer patients that consent will receive face-up CT
      simulation with and without gating AND face-down CT simulation, regardless of breast size;
      thus, each patient is their own control.

      The treating physician will determine which of the two simulations, if any, offers better
      protection to each patients' heart and lungs. Two dosimetrists will be required to
      independently verify planned dosimetry with all treatment setups. Treatment will be planned
      in standard fashion using the best of the two plans.
Radiation therapy to the breast has remained a standard practice for breast conserving
      therapy. Because of the location of the heart and lungs when patients are positioned face-up,
      whole breast radiation therapy has been reported to increase the risk of damage to the heart
      a few years after treatment until at least 20 years after exposure, and may affect
      cardiovascular mortality. Also, patients receiving whole breast radiation therapy are at an
      increased risk for development of secondary lung malignancies. Recent studies have
      demonstrated a significant reduction in dose to the heart and lungs when treated in the
      face-down position. Similarly, correcting for the movement of breathing (respiratory gating)
      in the face-up position has also become an available option for reducing unwanted dose to the
      heart and lungs, particularly in left sided breast cancers. No study to date has compared
      these newer organ-sparing techniques head-to-head for early stage breast cancer.

      It is institutional policy to perform CT simulation in left-sided breast cancer patients with
      and without the respiratory gating (this is one CT scan), in the face-up position. It is also
      standard of care to perform the face-down CT simulation in large breasted women. Both of
      these simulations are meant to reduce the exposure of the heart and lungs to radiation. In
      this study, all left-sided breast cancer patients that consent will receive face-up CT
      simulation with and without gating AND face-down CT simulation, regardless of breast size;
      thus, each patient is their own control.

      The treating physician will determine which of the two simulations, if any, offers better
      protection to each patients' heart and lungs. Two dosimetrists will be required to
      independently verify planned dosimetry with all treatment setups. Treatment will be planned
      in standard fashion using the best of the two plans.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: mean heart dose
time frame: immediate
description: dosimetric parameter
arm group label: Prone/Supine Simulation
arm group type: Other
description: It is institutional policy to perform CT simulation in left-sided breast cancer patients with and without the respiratory gating (this is one CT scan), in the face-up position. It is also standard of care to perform the face-down CT simulation in large breasted women. Both of these simulations are meant to reduce the exposure of the heart and lungs to radiation. In this study, all left-sided breast cancer patients that consent will receive face-up CT simulation with and without gating AND face-down CT simulation, regardless of breast size; thus, each patient is their own control.
intervention type: Other
intervention name: CT simulation
arm group label: Prone/Supine Simulation
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
citation: Darby SC, McGale P, Taylor CW, Peto R. Long-term mortality from heart disease and lung cancer after radiotherapy for early breast cancer: prospective cohort study of about 300,000 women in US SEER cancer registries. Lancet Oncol. 2005 Aug;6(8):557-65. doi: 10.1016/S1470-2045(05)70251-5.
PMID: 16054566
citation: Darby SC, Ewertz M, McGale P, Bennet AM, Blom-Goldman U, Bronnum D, Correa C, Cutter D, Gagliardi G, Gigante B, Jensen MB, Nisbet A, Peto R, Rahimi K, Taylor C, Hall P. Risk of ischemic heart disease in women after radiotherapy for breast cancer. N Engl J Med. 2013 Mar 14;368(11):987-98. doi: 10.1056/NEJMoa1209825.
PMID: 23484825
citation: Deutsch M, Land SR, Begovic M, Wieand HS, Wolmark N, Fisher B. The incidence of lung carcinoma after surgery for breast carcinoma with and without postoperative radiotherapy. Results of National Surgical Adjuvant Breast and Bowel Project (NSABP) clinical trials B-04 and B-06. Cancer. 2003 Oct 1;98(7):1362-8. doi: 10.1002/cncr.11655.
PMID: 14508821
citation: Ng J, Shuryak I, Xu Y, Clifford Chao KS, Brenner DJ, Burri RJ. Predicting the risk of secondary lung malignancies associated with whole-breast radiation therapy. Int J Radiat Oncol Biol Phys. 2012 Jul 15;83(4):1101-6. doi: 10.1016/j.ijrobp.2011.09.052. Epub 2012 Jan 13.
PMID: 22245205
citation: Lymberis SC, deWyngaert JK, Parhar P, Chhabra AM, Fenton-Kerimian M, Chang J, Hochman T, Guth A, Roses D, Goldberg JD, Formenti SC. Prospective assessment of optimal individual position (prone versus supine) for breast radiotherapy: volumetric and dosimetric correlations in 100 patients. Int J Radiat Oncol Biol Phys. 2012 Nov 15;84(4):902-9. doi: 10.1016/j.ijrobp.2012.01.040. Epub 2012 Apr 9.
PMID: 22494590
citation: Qi XS, Hu A, Wang K, Newman F, Crosby M, Hu B, White J, Li XA. Respiration induced heart motion and indications of gated delivery for left-sided breast irradiation. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):1605-11. doi: 10.1016/j.ijrobp.2011.01.042. Epub 2011 Apr 12.
PMID: 21489710
responsible party type: Principal Investigator
investigator affiliation: State University of New York - Upstate Medical University
investigator full name: Anna Shapiro
investigator title: Associate Professor
sharing ipd: No