<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/NCT03837782</url>
  </required_header>
  <id_info>
    <org_study_id>LRLCC</org_study_id>
    <nct_id>NCT03837782</nct_id>
  </id_info>
  <brief_title>Outcome of Resection for Colorectal Cancer</brief_title>
  <acronym>LRLCC</acronym>
  <official_title>Minimally Invasive Versus Abdominal Radical Resection for Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Medical University Cancer Institute and Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Qilu Hospital of Shandong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University Cancer Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhengzhou University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking Union Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Harvard Medical School (HMS and HSDM)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tianjin Medical University Cancer Institute and Hospital</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>
      There are limited data from retrospective studies regarding whether short-term and long-term&#xD;
      outcomes after laparoscopic or robot-assisted radical colectomy (minimally invasive surgery)&#xD;
      are equivalent to those after open abdominal radical colectomy (open surgery) among patients&#xD;
      with early and medium-stage colorectal cancer.&#xD;
&#xD;
      This trial is a multicenter,prospective, randomized trial evaluating short-term and survival&#xD;
      outcomes concerning minimally invasive surgery and open surgery for colorectal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Radical colectomy and proctectomy with regional lymphadenectomy remain the standard&#xD;
      recommendation for patients with early and medium-stage colorectal cancer. Current guidelines&#xD;
      from the National Comprehensive Cancer Network indicate that either laparotomy (open surgery)&#xD;
      or laparoscopy (minimally invasive surgery performed with either conventional or robotic&#xD;
      techniques) is an acceptable approach to radical resection in patients with early- and medium&#xD;
      stage (I to III) colorectal cancer. These recommendations have led to widespread use of a&#xD;
      minimally invasive approach for radical resection, although there is a paucity of adequately&#xD;
      powered, prospective, randomized trials evaluating short term and survival outcomes.&#xD;
&#xD;
      Retrospective studies involving patients with early and medium-stage colorectal cancer have&#xD;
      shown that laparoscopic resection is associated with less intraoperative blood loss, a&#xD;
      shorter length of hospital stay, and a lower risk of postoperative complications than open&#xD;
      abdominal radical resection. Similarly, the minimally invasive approach has not been&#xD;
      associated with lower 5-year rates of disease-free survival or overall survival than the open&#xD;
      approach. In addition, retrospective studies have shown that recurrence rates and survival&#xD;
      rates do not differ significantly between the two approaches.&#xD;
&#xD;
      The investigators hypothesized that minimally invasive surgery was not inferior or superior&#xD;
      to open radical resection in terms of short-term and long-term outcome. In the present trial,&#xD;
      the Laparoscopic Resection and Laparotomy for Colorectal Cancer (LRLCC) Trial, the&#xD;
      investigators tested this hypothesis by prospectively assigning patients to minimally&#xD;
      invasive (conventional laparoscopic or robotic) or open abdominal radical surgery and&#xD;
      comparing the short-term outcome, the rate of recurrence, and the overall survival rate&#xD;
      between the two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Anticipated">February 15, 2019</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">November 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>multicenter, randomized trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Patients were randomized to be distributed to any group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>complications</measure>
    <time_frame>through hospital stay, an average of two weeks</time_frame>
    <description>complications includes intraoperative and postoperative complications, such as huge blood loss, anastomotic fistula, abdominal infection and septic shock.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>disease free survival</measure>
    <time_frame>From date of randomization until the date of first documented progression, assessed up to 70 months</time_frame>
    <description>Disease-free survival (DFS) was defined as the interval between the date of surgical resection and diagnosis of recurrence or the most recent follow-up date.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>overall survival</measure>
    <time_frame>From date of randomization until the date of death from any cause, assessed up to 70 months.</time_frame>
    <description>Overall survival (OS) was measured from the date of hepatectomy to death with or without HCC recurrence or the end of this study period.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1300</enrollment>
  <condition>Laparoscopy</condition>
  <arm_group>
    <arm_group_label>minimally invasive surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients were randomized to undergo minimally invasive radical resection (endoscopic surgery or robotic assisted surgery). Each participating site required accreditation by the trial management committee to ensure proper surgical technique during minimally invasive surgery.&#xD;
Patients were eligible if they had colorectal adenocarcinoma; had a disease stage of I (T1,T2), IIABC (T3-T4ab) or IIIABC (TanyN1-2) according to the staging system of NCCN; and had an Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1 (on a 5-point scale, with higher values indicating greater disability).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>open surgery</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients were randomized to undergo open radical resection (laparotomy). Each participating site required accreditation by the trial management committee to ensure proper surgical technique during minimally invasive surgery.&#xD;
Patients were eligible if they had colorectal adenocarcinoma; had a disease stage of I (T1,T2), IIABC (T3-T4ab) or IIIABC (TanyN1-2) according to the staging system of NCCN; and had an Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1 (on a 5-point scale, with higher values indicating greater disability).&#xD;
Exclusion criteria included a history of abdominal or pelvic radiotherapy, or evidence of metastatic disease on positron-emission tomography-computed tomography, magnetic resonance imaging, or computed tomography.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>minimally invasive surgery</intervention_name>
    <description>Each participating site required accreditation by the trial management committee to ensure proper surgical technique during minimally invasive surgery. No individual surgeons performed only the open approach or only the minimally invasive approach. The committee members reviewed the patients' outcomes and the videos to ensure the adequacy of the surgeon's technique.</description>
    <arm_group_label>minimally invasive surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (i) tumor without distant metastasis; (ii) classified as stage I, II or III by TNM staging&#xD;
        system; (iii) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; (iv)&#xD;
        a minimum of 12 lymph nodes resected to accurately identify stage; (v) solitary malignant&#xD;
        lesion after thorough colonoscopy; (vi) complete resection (R0) with no positive nodes left&#xD;
        behind; (vii) histological diagnosis of adenocarcinoma.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        (i) &lt;18 years or &gt;90 years; (ii) serious concurrent illness; (iii) clinically suspicious&#xD;
        distant metastasis detected by positron emission tomography-computed tomography (PET-CT);&#xD;
        (iv) familial adenomatous polyposis syndrome (FAP), hereditary non-polyposis colorectal&#xD;
        cancer (HNPCC) and other hereditary CRC; (v) postoperative pathological close,&#xD;
        indeterminate, or positive margins; (vi) circumferential resection margin &lt; 1mm in rectal&#xD;
        cancer; (vii) short anticipated life expectancy due to postoperative comorbidities on&#xD;
        account of cardiopulmonary insufficiency.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dalu M Kong, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Tianjin Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute and Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>February 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 9, 2019</last_update_submitted>
  <last_update_submitted_qc>February 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>laparoscopy,laparotomy,colorectal cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal 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/NCT03837782
org study id: LRLCC
nct id: NCT03837782
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
There are limited data from retrospective studies regarding whether short-term and long-term
      outcomes after laparoscopic or robot-assisted radical colectomy (minimally invasive surgery)
      are equivalent to those after open abdominal radical colectomy (open surgery) among patients
      with early and medium-stage colorectal cancer.

      This trial is a multicenter,prospective, randomized trial evaluating short-term and survival
      outcomes concerning minimally invasive surgery and open surgery for colorectal cancer.
Radical colectomy and proctectomy with regional lymphadenectomy remain the standard
      recommendation for patients with early and medium-stage colorectal cancer. Current guidelines
      from the National Comprehensive Cancer Network indicate that either laparotomy (open surgery)
      or laparoscopy (minimally invasive surgery performed with either conventional or robotic
      techniques) is an acceptable approach to radical resection in patients with early- and medium
      stage (I to III) colorectal cancer. These recommendations have led to widespread use of a
      minimally invasive approach for radical resection, although there is a paucity of adequately
      powered, prospective, randomized trials evaluating short term and survival outcomes.

      Retrospective studies involving patients with early and medium-stage colorectal cancer have
      shown that laparoscopic resection is associated with less intraoperative blood loss, a
      shorter length of hospital stay, and a lower risk of postoperative complications than open
      abdominal radical resection. Similarly, the minimally invasive approach has not been
      associated with lower 5-year rates of disease-free survival or overall survival than the open
      approach. In addition, retrospective studies have shown that recurrence rates and survival
      rates do not differ significantly between the two approaches.

      The investigators hypothesized that minimally invasive surgery was not inferior or superior
      to open radical resection in terms of short-term and long-term outcome. In the present trial,
      the Laparoscopic Resection and Laparotomy for Colorectal Cancer (LRLCC) Trial, the
      investigators tested this hypothesis by prospectively assigning patients to minimally
      invasive (conventional laparoscopic or robotic) or open abdominal radical surgery and
      comparing the short-term outcome, the rate of recurrence, and the overall survival rate
      between the two groups.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: multicenter, randomized trial
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Patients were randomized to be distributed to any group.
measure: complications
time frame: through hospital stay, an average of two weeks
description: complications includes intraoperative and postoperative complications, such as huge blood loss, anastomotic fistula, abdominal infection and septic shock.
measure: disease free survival
time frame: From date of randomization until the date of first documented progression, assessed up to 70 months
description: Disease-free survival (DFS) was defined as the interval between the date of surgical resection and diagnosis of recurrence or the most recent follow-up date.
measure: overall survival
time frame: From date of randomization until the date of death from any cause, assessed up to 70 months.
description: Overall survival (OS) was measured from the date of hepatectomy to death with or without HCC recurrence or the end of this study period.
arm group label: minimally invasive surgery
arm group type: Experimental
description: Patients were randomized to undergo minimally invasive radical resection (endoscopic surgery or robotic assisted surgery). Each participating site required accreditation by the trial management committee to ensure proper surgical technique during minimally invasive surgery.
Patients were eligible if they had colorectal adenocarcinoma; had a disease stage of I (T1,T2), IIABC (T3-T4ab) or IIIABC (TanyN1-2) according to the staging system of NCCN; and had an Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1 (on a 5-point scale, with higher values indicating greater disability).
arm group label: open surgery
arm group type: No Intervention
description: Patients were randomized to undergo open radical resection (laparotomy). Each participating site required accreditation by the trial management committee to ensure proper surgical technique during minimally invasive surgery.
Patients were eligible if they had colorectal adenocarcinoma; had a disease stage of I (T1,T2), IIABC (T3-T4ab) or IIIABC (TanyN1-2) according to the staging system of NCCN; and had an Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1 (on a 5-point scale, with higher values indicating greater disability).
Exclusion criteria included a history of abdominal or pelvic radiotherapy, or evidence of metastatic disease on positron-emission tomography-computed tomography, magnetic resonance imaging, or computed tomography.
intervention type: Procedure
intervention name: minimally invasive surgery
description: Each participating site required accreditation by the trial management committee to ensure proper surgical technique during minimally invasive surgery. No individual surgeons performed only the open approach or only the minimally invasive approach. The committee members reviewed the patients' outcomes and the videos to ensure the adequacy of the surgeon's technique.
arm group label: minimally invasive surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Dalu M Kong, M.D.
role: Study Director
affiliation: Tianjin Medical University
facility: 
country: China
responsible party type: Sponsor
mesh term: Colorectal Neoplasms