<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/NCT04443985</url>
  </required_header>
  <id_info>
    <org_study_id>MURA2019/249</org_study_id>
    <nct_id>NCT04443985</nct_id>
  </id_info>
  <brief_title>A Cohort of Predictive Factor of Pathologic Complete Response After Preoperative Neoadjuvant in Rectum Cancer</brief_title>
  <official_title>A Cohort of Predictive Factor of Pathologic Complete Response After Preoperative Neoadjuvant in Rectum Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ramathibodi Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mahidol University</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>
      Due to colorectal cancer is the fourth most common malignancy in the world. Some patients had&#xD;
      present locally advance stage and need to preoperative concurrent chemoradiation (CCRT)&#xD;
      before radical surgery. But predictor for pathologic complete response (pCR) after&#xD;
      preoperative CCRT remain unclear.&#xD;
&#xD;
      Objectives: To identify possible factor for predict of pCR of rectal cancer after&#xD;
      preoperative CCRT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After permission was obtained from our institutional review board, a cohort of patients who&#xD;
      were diagnosed with rectal cancer and received chemoradiation between January 2011 to&#xD;
      December 2017 at Ramathibodi hospital, Bangkok were analyzed. Patients who were not received&#xD;
      neoadjuvant chemoradiation therapy, loss follow-up, incomplete data in the record, distant&#xD;
      organ metastasis and who was not received colorectal surgery were excluded as study flow&#xD;
      diagram. Age, sex, performance status, smoking, initial Hb level (g/mL), CEA level (ng/dL),&#xD;
      distance of tumor from anal verge, diagnostic variables, clinical T staging, preoperative&#xD;
      thickness and length from computer tomography scan (CT scan), organ metastasis before&#xD;
      treatment, histology, treatment course, and outcomes after treatment were collected and&#xD;
      analyzed.Total dose of radiation, interval time from CCRT to operation, and chemotherapy&#xD;
      regimens were also collected between and after treatment. After preoperative CCRT, the&#xD;
      radical rectal surgery was performed by eight experienced general surgeons and surgical&#xD;
      oncologist using open and laparoscopic techniques. Perioperative data were collected and&#xD;
      histology was evaluated by an experienced pathologists. For pathological classification,&#xD;
      pathological responses were divided in 2 groups i.e., pathologic complete response (pCR&#xD;
      group) and non-pCR group, (partial response, stable disease, and disease progression). Margin&#xD;
      of lesions were classified as proximal, distal and circumferential margins. Lymph nodes&#xD;
      status after surgery were specified as total lymph nodes harvested and positive lymph nodes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">August 10, 2020</completion_date>
  <primary_completion_date type="Actual">July 20, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Stage</measure>
    <time_frame>1 month</time_frame>
    <description>Pathological of Tumor follow by The American Joint Committee on Cancer (AJCC) edition 8</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lymph node</measure>
    <time_frame>1 month</time_frame>
    <description>Pathological of lymph node follow by The American Joint Committee on Cancer (AJCC) edition 8</description>
  </primary_outcome>
  <enrollment type="Actual">140</enrollment>
  <condition>Rectum Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who were diagnosed with rectal cancer and received chemoradiation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  rectal cancer and received preoperative chemoradiation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  distant organ metastasis&#xD;
&#xD;
          -  previous colorectal surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Chairat Supsamutchai, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Ramathibodi Hospital, Mahidol University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chairat Supsamutchai</name>
      <address>
        <city>Bangkok</city>
        <state>Bankok</state>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>May 15, 2022</last_update_submitted>
  <last_update_submitted_qc>May 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Preoperative chemoradiation</keyword>
  <keyword>Rectum cancer</keyword>
  <keyword>Pathological complete response</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal 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/NCT04443985
org study id: MURA2019/249
nct id: NCT04443985
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Due to colorectal cancer is the fourth most common malignancy in the world. Some patients had
      present locally advance stage and need to preoperative concurrent chemoradiation (CCRT)
      before radical surgery. But predictor for pathologic complete response (pCR) after
      preoperative CCRT remain unclear.

      Objectives: To identify possible factor for predict of pCR of rectal cancer after
      preoperative CCRT.
After permission was obtained from our institutional review board, a cohort of patients who
      were diagnosed with rectal cancer and received chemoradiation between January 2011 to
      December 2017 at Ramathibodi hospital, Bangkok were analyzed. Patients who were not received
      neoadjuvant chemoradiation therapy, loss follow-up, incomplete data in the record, distant
      organ metastasis and who was not received colorectal surgery were excluded as study flow
      diagram. Age, sex, performance status, smoking, initial Hb level (g/mL), CEA level (ng/dL),
      distance of tumor from anal verge, diagnostic variables, clinical T staging, preoperative
      thickness and length from computer tomography scan (CT scan), organ metastasis before
      treatment, histology, treatment course, and outcomes after treatment were collected and
      analyzed.Total dose of radiation, interval time from CCRT to operation, and chemotherapy
      regimens were also collected between and after treatment. After preoperative CCRT, the
      radical rectal surgery was performed by eight experienced general surgeons and surgical
      oncologist using open and laparoscopic techniques. Perioperative data were collected and
      histology was evaluated by an experienced pathologists. For pathological classification,
      pathological responses were divided in 2 groups i.e., pathologic complete response (pCR
      group) and non-pCR group, (partial response, stable disease, and disease progression). Margin
      of lesions were classified as proximal, distal and circumferential margins. Lymph nodes
      status after surgery were specified as total lymph nodes harvested and positive lymph nodes.
observational model: Cohort
time perspective: Retrospective
measure: Stage
time frame: 1 month
description: Pathological of Tumor follow by The American Joint Committee on Cancer (AJCC) edition 8
measure: Lymph node
time frame: 1 month
description: Pathological of lymph node follow by The American Joint Committee on Cancer (AJCC) edition 8
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Chairat Supsamutchai, MD
role: Study Chair
affiliation: Ramathibodi Hospital, Mahidol University
facility: 
country: Thailand
responsible party type: Sponsor
mesh term: Rectal Neoplasms
sharing ipd: No