<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/NCT04456283</url>
  </required_header>
  <id_info>
    <org_study_id>9076078</org_study_id>
    <nct_id>NCT04456283</nct_id>
  </id_info>
  <brief_title>Survival of Patients With a Reduction in the Number of Lymph Nodes in Rectal Cancer After Neoadjuvant Chemoradiotherapy</brief_title>
  <official_title>Prospective Analysis of the Survival of Patients With a Reduction in the Number of Lymph Nodes in Rectal Cancer After Neoadjuvant Chemoradiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>SERGIO CARLOS NAHAS</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CAIO SERGIO NAHAS</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ivan Cecconello</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ulysses Ribeiro Junior</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Objective: To analyze the survival of patients with a reduction in the number of resected LN&#xD;
      in patients submitted to neoadjuvant and total excision of the mesorectum with rectal cancer.&#xD;
&#xD;
      Expected results:&#xD;
&#xD;
      Survival rate between patients Complete Pathologic Response with less than 12 LN and 12 or&#xD;
      more LN.&#xD;
&#xD;
      To determine the difference in survival between patients with less than 12 LN in complete&#xD;
      versus incomplete response.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to the International Union Against Cancer a minimum of 12 lymph nodes (LN) should&#xD;
      be obtained in the surgical specimen for colorectal cancer staging. Recent studies have&#xD;
      reported that the use of neoadjuvant chemoradiotherapy (QRN) may result in failure to obtain&#xD;
      the minimum number of LN in the piece in 30-52% of patients. Objective: To analyze the&#xD;
      survival of patients with a reduction in the number of resected LN in patients submitted to&#xD;
      neoadjuvant and total excision of the mesorectum with rectal cancer. Patients and methods:&#xD;
      From January 2013 to January 2015, patients with rectal cancer were submitted to QRN (5-FU&#xD;
      and 5040 Gys) followed by total excision of mesorectum with ligation of the inferior&#xD;
      mesenteric vessels in their roots. Patients with T3, T4 and / or N + staging that were up to&#xD;
      10 cm from the anal border were included. Patients whose treatment with neoadjuvant&#xD;
      chemoradiotherapy was incomplete or who had significant delays in re- staging and / or&#xD;
      performing the surgery were excluded. All were staged by rectal examination, colonoscopy,&#xD;
      chest and abdominal CT, and pelvic MRI, and also re-staged 8 weeks after neoadjuvant&#xD;
      termination, operated and submitted to total excision of the mesorectum. The patients were&#xD;
      divided into 4 groups: a) Incomplete pathological response with less than 12 LN. b)&#xD;
      Incomplete pathological response with 12 or more LN. c) Complete pathological response with&#xD;
      less than 12 LN. d) Complete pathological response with 12 or more LN. The possible variables&#xD;
      related to the number of LN obtained and related to general and disease free survival were&#xD;
      studied.&#xD;
&#xD;
      Expected results:&#xD;
&#xD;
      To analyze the survival rate between patients Complete Pathologic Response with less than 12&#xD;
      LN and 12 or more LN. To determine the difference in survival between patients with less than&#xD;
      12 LN in complete versus incomplete response. Demonstrate that patients with complete&#xD;
      pathologic response and less than 12 LN have a disease-free survival equal to or better than&#xD;
      patients with 12 LN or more.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 20, 2019</start_date>
  <completion_date type="Anticipated">July 15, 2021</completion_date>
  <primary_completion_date type="Actual">May 15, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>5 years Survival</measure>
    <time_frame>5 years</time_frame>
    <description>5 years Survival</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Cancer of Rectum</condition>
  <condition>Lymph Node Disease</condition>
  <arm_group>
    <arm_group_label>Incomplete pathological response with less than 12 LN.</arm_group_label>
    <description>Patients with incomplete pathological response after Chemoradiation theraphy for Rectal Cancer and less than 12 lymph nodes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Incomplete pathological response with 12 or more LN.</arm_group_label>
    <description>Patients with incomplete pathological response after Chemoradiation theraphy for Rectal Cancer and 12 lymph or more nodes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Complete pathological response with less than 12 LN.</arm_group_label>
    <description>Patients with complete pathological response after Chemoradiation theraphy for Rectal Cancer and less than 12 lymph nodes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Complete pathological response with 12 or more LN.</arm_group_label>
    <description>Patients with complete pathological response after Chemoradiation theraphy for Rectal Cancer and 12 lymph or more nodes</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Survival</intervention_name>
    <description>5 year survival after Chemoradiation theraphy for Rectal Cancer</description>
    <arm_group_label>Complete pathological response with 12 or more LN.</arm_group_label>
    <arm_group_label>Complete pathological response with less than 12 LN.</arm_group_label>
    <arm_group_label>Incomplete pathological response with 12 or more LN.</arm_group_label>
    <arm_group_label>Incomplete pathological response with less than 12 LN.</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with mid and low rectal cancer within 10 cm from the anal verge, stage cT3-4N0M0&#xD;
        or cT (any)N + M0&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: Patients with a biopsy-proven mid and low rectal adenocarcinoma located&#xD;
        within 10 cm from the anal verge, stage cT3-4N0M0 or cT (any)N + M0, and patients with low&#xD;
        (&lt; 5 cm from anal verge) cT2N0 of distal rectum because of the risk of needing an&#xD;
        abdominoperineal resection.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria: Patients with synchronous colorectal cancer or other non-colorectal&#xD;
        cancers, stage IV disease, rectal cancer in the setting of inflammatory bowel disease or&#xD;
        familial adenomatous polyposis, palliative resections, previous pelvic radiotherapy,&#xD;
        significant comorbidities that prevent curative surgical resection and/or CRT, concurrent&#xD;
        participation in another research protocol involving therapeutic intervention&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Medicine School, Sao Paulo University</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Leonardo A Bustamante, Surgeon</last_name>
      <phone>55 11 985000091</phone>
      <email>leo708@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Leonardo A Bustamante L, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 28, 2020</last_update_submitted>
  <last_update_submitted_qc>June 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Leonardo Alfonso Bustamante</investigator_full_name>
    <investigator_title>Post doctoral fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal 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/NCT04456283
org study id: 9076078
nct id: NCT04456283
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objective: To analyze the survival of patients with a reduction in the number of resected LN
      in patients submitted to neoadjuvant and total excision of the mesorectum with rectal cancer.

      Expected results:

      Survival rate between patients Complete Pathologic Response with less than 12 LN and 12 or
      more LN.

      To determine the difference in survival between patients with less than 12 LN in complete
      versus incomplete response.
According to the International Union Against Cancer a minimum of 12 lymph nodes (LN) should
      be obtained in the surgical specimen for colorectal cancer staging. Recent studies have
      reported that the use of neoadjuvant chemoradiotherapy (QRN) may result in failure to obtain
      the minimum number of LN in the piece in 30-52% of patients. Objective: To analyze the
      survival of patients with a reduction in the number of resected LN in patients submitted to
      neoadjuvant and total excision of the mesorectum with rectal cancer. Patients and methods:
      From January 2013 to January 2015, patients with rectal cancer were submitted to QRN (5-FU
      and 5040 Gys) followed by total excision of mesorectum with ligation of the inferior
      mesenteric vessels in their roots. Patients with T3, T4 and / or N + staging that were up to
      10 cm from the anal border were included. Patients whose treatment with neoadjuvant
      chemoradiotherapy was incomplete or who had significant delays in re- staging and / or
      performing the surgery were excluded. All were staged by rectal examination, colonoscopy,
      chest and abdominal CT, and pelvic MRI, and also re-staged 8 weeks after neoadjuvant
      termination, operated and submitted to total excision of the mesorectum. The patients were
      divided into 4 groups: a) Incomplete pathological response with less than 12 LN. b)
      Incomplete pathological response with 12 or more LN. c) Complete pathological response with
      less than 12 LN. d) Complete pathological response with 12 or more LN. The possible variables
      related to the number of LN obtained and related to general and disease free survival were
      studied.

      Expected results:

      To analyze the survival rate between patients Complete Pathologic Response with less than 12
      LN and 12 or more LN. To determine the difference in survival between patients with less than
      12 LN in complete versus incomplete response. Demonstrate that patients with complete
      pathologic response and less than 12 LN have a disease-free survival equal to or better than
      patients with 12 LN or more.
observational model: Case-Control
time perspective: Prospective
measure: 5 years Survival
time frame: 5 years
description: 5 years Survival
arm group label: Incomplete pathological response with less than 12 LN.
description: Patients with incomplete pathological response after Chemoradiation theraphy for Rectal Cancer and less than 12 lymph nodes
arm group label: Incomplete pathological response with 12 or more LN.
description: Patients with incomplete pathological response after Chemoradiation theraphy for Rectal Cancer and 12 lymph or more nodes
arm group label: Complete pathological response with less than 12 LN.
description: Patients with complete pathological response after Chemoradiation theraphy for Rectal Cancer and less than 12 lymph nodes
arm group label: Complete pathological response with 12 or more LN.
description: Patients with complete pathological response after Chemoradiation theraphy for Rectal Cancer and 12 lymph or more nodes
intervention type: Behavioral
intervention name: Survival
description: 5 year survival after Chemoradiation theraphy for Rectal Cancer
arm group label: Complete pathological response with 12 or more LN.
arm group label: Complete pathological response with less than 12 LN.
arm group label: Incomplete pathological response with 12 or more LN.
arm group label: Incomplete pathological response with less than 12 LN.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
facility: 
status: Recruiting
contact: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Leonardo Alfonso Bustamante
investigator title: Post doctoral fellow
mesh term: Rectal Neoplasms