<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/NCT03259828</url>
  </required_header>
  <id_info>
    <org_study_id>A-BR-106-037</org_study_id>
    <nct_id>NCT03259828</nct_id>
  </id_info>
  <brief_title>Sigmoid Colon Organ Motion in Radiotherapy</brief_title>
  <official_title>Interfraction and Intrafraction Organ Motion of the Sigmoid Colon in Patients With Colorectal Cancer Undergoing Adjuvant Radiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cheng-Kung University 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>
      Radiotherapy is used in cancer treatment to eradicate microscopic cancer cells to lower the&#xD;
      risk of recurrence. The radiotherapy plan must account for organ movement inside the body to&#xD;
      ascertain adequate dose is delivered to the target. Knowledge of the magnitude is crucial to&#xD;
      radiotherapy treatment planning. This study aims to quantify the movement of the sigmoid&#xD;
      colon between different fractions of radiotherapy treatment (interfraction motion) and within&#xD;
      the same fraction (intrafraction motion). This knowledge will help us determine the optimal&#xD;
      margin to use in radiotherapy treatment planning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Day-to-day positioning variations contribute to uncertainty in radiotherapy. The&#xD;
      International Commission on Radiation Units and Measurements (ICRU) report 62 recommended a&#xD;
      margin added to the clinical target volume (CTV) to produce the planning target volume (PTV).&#xD;
      In ICRU report 83, this concept is further extended and refined to yield the internal target&#xD;
      volume (ITV), which is defined as CTV plus a margin to account for uncertainty within the&#xD;
      patient. Image-guided radiotherapy (IGRT) has been developed as a method to lower the margin&#xD;
      required in PTV expansion. In current practice, IGRT methods mostly rely on bony anatomy&#xD;
      alignment. Due to its nature, internal organ motion cannot be compensated by IGRT. Therefore,&#xD;
      an ITV expansion is still required. The optimal ITV expansion margin depends on the magnitude&#xD;
      of internal organ motion; the smallest margin that provides adequate coverage is preferred.&#xD;
&#xD;
      In this study, we aim to quantify organ motion of the sigmoid colon anastomosis site during&#xD;
      radiotherapy treatment, including movement between fractions (interfraction) and movement&#xD;
      within the same fraction (intrafraction).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2017</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Interfraction sigmoid colon organ motion</measure>
    <time_frame>90 days</time_frame>
    <description>Offset of the sigmoid colon staple site in three axes (anterior-posterior, lateral, and cranial-caudal) compared to simulation CT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intrafraction sigmoid colon organ motion</measure>
    <time_frame>90 days</time_frame>
    <description>Offset of the sigmoid colon staple site in three axes (anterior-posterior, lateral, and cranial-caudal) between pre-treatment cone beam computed tomography (CBCT) and post-treatment CBCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Setup errors</measure>
    <time_frame>90 days</time_frame>
    <description>Offset of couch (set-up error) when matching the pre-treatment CBCT with simulation CT</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Sigmoid Cancer</condition>
  <condition>Sigmoid Colon Cancer</condition>
  <arm_group>
    <arm_group_label>Adjuvant image-guided radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adjuvant radiotherapy with image guidance via cone beam computed tomography. Treatment is identical to the current standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Adjuvant image-guided radiotherapy</intervention_name>
    <description>Image-guided adjuvant radiotherapy to the sigmoid colon surgical tumor bed and pelvic regional lymph nodes: 45-50.4 Gy in 1.8 Gy/fraction</description>
    <arm_group_label>Adjuvant image-guided radiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with pathologically confirmed sigmoid colon cancer, who have received&#xD;
             surgical excision (AR or LAR).&#xD;
&#xD;
          -  Anastomosis of the colon must be performed with a surgical stapler, with the staple&#xD;
             visible on CT imaging.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gross recurrent disease (defined as visible mass on CT imaging) in the pelvis.&#xD;
&#xD;
          -  Other malignancy within the pelvic cavity.&#xD;
&#xD;
          -  Previous surgery to the pelvic cavity other than AR/LAR.&#xD;
&#xD;
          -  Pregnant or lactating females.&#xD;
&#xD;
          -  Subjects who, in the opinion of the Investigator, may be non-compliant with study&#xD;
             schedules or procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mu-Hung Tsai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cheng-Kung University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>February 4, 2021</last_update_submitted>
  <last_update_submitted_qc>February 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cheng-Kung University Hospital</investigator_affiliation>
    <investigator_full_name>Tsai, Mu-Hung</investigator_full_name>
    <investigator_title>Attending Physician</investigator_title>
  </responsible_party>
  <keyword>Sigmoid colon cancer</keyword>
  <keyword>Internal organ motion</keyword>
  <keyword>Radiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
    <mesh_term>Sigmoid Neoplasms</mesh_term>
  </condition_browse>
  <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/NCT03259828
org study id: A-BR-106-037
nct id: NCT03259828
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Radiotherapy is used in cancer treatment to eradicate microscopic cancer cells to lower the
      risk of recurrence. The radiotherapy plan must account for organ movement inside the body to
      ascertain adequate dose is delivered to the target. Knowledge of the magnitude is crucial to
      radiotherapy treatment planning. This study aims to quantify the movement of the sigmoid
      colon between different fractions of radiotherapy treatment (interfraction motion) and within
      the same fraction (intrafraction motion). This knowledge will help us determine the optimal
      margin to use in radiotherapy treatment planning.
Day-to-day positioning variations contribute to uncertainty in radiotherapy. The
      International Commission on Radiation Units and Measurements (ICRU) report 62 recommended a
      margin added to the clinical target volume (CTV) to produce the planning target volume (PTV).
      In ICRU report 83, this concept is further extended and refined to yield the internal target
      volume (ITV), which is defined as CTV plus a margin to account for uncertainty within the
      patient. Image-guided radiotherapy (IGRT) has been developed as a method to lower the margin
      required in PTV expansion. In current practice, IGRT methods mostly rely on bony anatomy
      alignment. Due to its nature, internal organ motion cannot be compensated by IGRT. Therefore,
      an ITV expansion is still required. The optimal ITV expansion margin depends on the magnitude
      of internal organ motion; the smallest margin that provides adequate coverage is preferred.

      In this study, we aim to quantify organ motion of the sigmoid colon anastomosis site during
      radiotherapy treatment, including movement between fractions (interfraction) and movement
      within the same fraction (intrafraction).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Interfraction sigmoid colon organ motion
time frame: 90 days
description: Offset of the sigmoid colon staple site in three axes (anterior-posterior, lateral, and cranial-caudal) compared to simulation CT
measure: Intrafraction sigmoid colon organ motion
time frame: 90 days
description: Offset of the sigmoid colon staple site in three axes (anterior-posterior, lateral, and cranial-caudal) between pre-treatment cone beam computed tomography (CBCT) and post-treatment CBCT
measure: Setup errors
time frame: 90 days
description: Offset of couch (set-up error) when matching the pre-treatment CBCT with simulation CT
arm group label: Adjuvant image-guided radiotherapy
arm group type: Experimental
description: Adjuvant radiotherapy with image guidance via cone beam computed tomography. Treatment is identical to the current standard of care.
intervention type: Radiation
intervention name: Adjuvant image-guided radiotherapy
description: Image-guided adjuvant radiotherapy to the sigmoid colon surgical tumor bed and pelvic regional lymph nodes: 45-50.4 Gy in 1.8 Gy/fraction
arm group label: Adjuvant image-guided radiotherapy
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Mu-Hung Tsai, MD
role: Principal Investigator
affiliation: National Cheng-Kung University Hospital
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Cheng-Kung University Hospital
investigator full name: Tsai, Mu-Hung
investigator title: Attending Physician
mesh term: Colonic Neoplasms
mesh term: Sigmoid Neoplasms
sharing ipd: No