<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/NCT03009227</url>
  </required_header>
  <id_info>
    <org_study_id>COL-1</org_study_id>
    <nct_id>NCT03009227</nct_id>
  </id_info>
  <brief_title>Study of Oncological Outcomes of D3 Lymph Node Dissection in Colon Cancer</brief_title>
  <acronym>COLD</acronym>
  <official_title>Study of Oncological Outcomes of D3 Lymph Node Dissection in Colon Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>N.N. Petrov National Medical Research Center of Oncology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>N.N. Petrov National Medical Research Center of Oncology</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>
      The purpose of this study is to determine wether D3 lymph node dissection gives superior&#xD;
      oncological outcomes compared to standard D2 lymph node dissection in colon cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The design involves random allocation of eligible patients to D3 or D2 lymph node dissection&#xD;
      group in 1:1 ratio. The extent of colonic resection itself is not influenced by the&#xD;
      randomization and is predefined by the investigator prior to randomization.&#xD;
&#xD;
      Requirements applied to centers participating in the trial and surgeons performing procedures&#xD;
      are described in the protocol and refer to center volume and surgeon's experience with&#xD;
      evaluation of non-edited video-recordings of procedures.&#xD;
&#xD;
      Routine quality control includes requirement to photograph vessels with the clip to determine&#xD;
      the extent of lymph node dissection performed and a thorough morphological assessment of the&#xD;
      specimen.&#xD;
&#xD;
      After surgery patients are treated according to local standards with no difference wether D2&#xD;
      or D3 lymph node dissection was performed. Short-term and long-term outcomes are registered&#xD;
      as per protocol.&#xD;
&#xD;
      This is a superiority trial evaluating statistical superiority. With the 50% five year&#xD;
      survival according to national registry for colon cancer, expecting 10% improvement in&#xD;
      survival with D3 lymph node dissection, enrollment of 768 patients during 3 year accrual&#xD;
      period followed by 5 year follow up is required for a power of 80%.&#xD;
&#xD;
      The intent-to-treat principle is used for the data analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 3, 2017</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2025</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>5 years after last patient enrolled</time_frame>
    <description>overall survival of patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>5 years after last patient enrolled</time_frame>
    <description>Survival without local or systemic recurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative morbidity</measure>
    <time_frame>within the first 30 days after surgery</time_frame>
    <description>Complications after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative mortality</measure>
    <time_frame>within the first 30 days after surgery</time_frame>
    <description>Death after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative recovery parameters</measure>
    <time_frame>within the first 30 days after surgery</time_frame>
    <description>Complex of parameters describing the pattern of recovery after surgery (i.e. food tolerance, peristalsis, walking etc.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pattern of lymph node metastasis based on pathology report</measure>
    <time_frame>enrollment period</time_frame>
    <description>Number of lymph node with metastases related to number of lymph nodes studied in each group in the specimen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CME quality</measure>
    <time_frame>enrollment period</time_frame>
    <description>Ratio of good, satisfactory and unsatisfactory quality according to pathology report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lymph node yield</measure>
    <time_frame>enrollment period</time_frame>
    <description>Number of lymph nodes removed according to pathology report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life in patients after D2 and D3 lymph node dissection using questionnaire</measure>
    <time_frame>enrollment period</time_frame>
    <description>CR29 and CR30 questionnaires by European Organization for Research and Treatment of Cancer</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">780</enrollment>
  <condition>Colonic Neoplasms Malignant</condition>
  <arm_group>
    <arm_group_label>D2 lymph node dissection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Colonic resection with D2 lymph node dissection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D3 lymph node dissection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Colonic resection with D3 lymph node dissection</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Colonic resection with D2 lymph node dissection</intervention_name>
    <description>Appropriate to the tumor location colonic resection is performed with D2 lymph node dissection</description>
    <arm_group_label>D2 lymph node dissection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Colonic resection with D3 lymph node dissection</intervention_name>
    <description>Appropriate to the tumor location colonic resection is performed with D3 lymph node dissection</description>
    <arm_group_label>D3 lymph node dissection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  histologically confirmed adenocarcinoma of the colon (caecum, ascending, transverse,&#xD;
             descending, sigmoid)&#xD;
&#xD;
          -  clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable)&#xD;
&#xD;
          -  indications for surgical colonic resection&#xD;
&#xD;
          -  ECOG status 0-2&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical or psychiatric conditions that compromise the patient's ability to give&#xD;
             informed consent or comply with the study protocol&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Medical contraindications for surgical treatment&#xD;
&#xD;
          -  Synchronous or metachronous malignancy&#xD;
&#xD;
          -  Non-resectable distant metastases&#xD;
&#xD;
          -  Colon obstruction, perforation or bleeding complicating the tumor&#xD;
&#xD;
          -  Indications for isolated transverse colon resection&#xD;
&#xD;
          -  Neoadjuvant chemotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aleksei Karachun, Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>N.N. Petrov Research Institute of Oncology, Surgical department of abdominal oncology, St. Petersburg, Russian Federation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Krasnodar City clinical hospital #1</name>
      <address>
        <city>Krasnodar</city>
        <zip>350000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Scientific Centre of Coloproctology</name>
      <address>
        <city>Moscow</city>
        <zip>123423</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow city oncological hospital #62</name>
      <address>
        <city>Moscow</city>
        <zip>125130</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>P. Herzen Moscow Oncology Research Institute</name>
      <address>
        <city>Moscow</city>
        <zip>125284</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical radiological scientific center named after A.F. Tsyba</name>
      <address>
        <city>Obninsk</city>
        <zip>450054</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rostov Research Institute of Oncology</name>
      <address>
        <city>Rostov</city>
        <zip>344037</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Petersburg City Clinical Oncology Dispensary</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint-Petersburg Clinical Research center of specialized kinds of medical care (Oncology)</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scientific-Research institute of Oncology named after N.N. Petrov</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint-Petersburg State University Clinic</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>198103</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pavlov First Saint Petersburg State Medical University</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Republican clinical oncological dispencery</name>
      <address>
        <city>Ufa</city>
        <zip>450054</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <reference>
    <citation>Karachun A, Petrov A, Panaiotti L, Voschinin Y, Ovchinnikova T. Protocol for a multicentre randomized clinical trial comparing oncological outcomes of D2 versus D3 lymph node dissection in colonic cancer (COLD trial). BJS Open. 2019 Mar 14;3(3):288-298. doi: 10.1002/bjs5.50142. eCollection 2019 Jun.</citation>
    <PMID>31183444</PMID>
  </reference>
  <results_reference>
    <citation>Karachun A, Panaiotti L, Chernikovskiy I, Achkasov S, Gevorkyan Y, Savanovich N, Sharygin G, Markushin L, Sushkov O, Aleshin D, Shakhmatov D, Nazarov I, Muratov I, Maynovskaya O, Olkina A, Lankov T, Ovchinnikova T, Kharagezov D, Kaymakchi D, Milakin A, Petrov A. Short-term outcomes of a multicentre randomized clinical trial comparing D2 versus D3 lymph node dissection for colonic cancer (COLD trial). Br J Surg. 2020 Apr;107(5):499-508. doi: 10.1002/bjs.11387. Epub 2019 Dec 24.</citation>
    <PMID>31872869</PMID>
  </results_reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>April 20, 2022</last_update_submitted>
  <last_update_submitted_qc>April 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>colon cancer</keyword>
  <keyword>lymph node dissection</keyword>
  <keyword>D3 lymph node dissection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We are not planning to share personal patient data</ipd_description>
  </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/NCT03009227
org study id: COL-1
nct id: NCT03009227
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine wether D3 lymph node dissection gives superior
      oncological outcomes compared to standard D2 lymph node dissection in colon cancer
The design involves random allocation of eligible patients to D3 or D2 lymph node dissection
      group in 1:1 ratio. The extent of colonic resection itself is not influenced by the
      randomization and is predefined by the investigator prior to randomization.

      Requirements applied to centers participating in the trial and surgeons performing procedures
      are described in the protocol and refer to center volume and surgeon's experience with
      evaluation of non-edited video-recordings of procedures.

      Routine quality control includes requirement to photograph vessels with the clip to determine
      the extent of lymph node dissection performed and a thorough morphological assessment of the
      specimen.

      After surgery patients are treated according to local standards with no difference wether D2
      or D3 lymph node dissection was performed. Short-term and long-term outcomes are registered
      as per protocol.

      This is a superiority trial evaluating statistical superiority. With the 50% five year
      survival according to national registry for colon cancer, expecting 10% improvement in
      survival with D3 lymph node dissection, enrollment of 768 patients during 3 year accrual
      period followed by 5 year follow up is required for a power of 80%.

      The intent-to-treat principle is used for the data analysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival
time frame: 5 years after last patient enrolled
description: overall survival of patients
measure: Disease-free survival
time frame: 5 years after last patient enrolled
description: Survival without local or systemic recurrence
measure: Postoperative morbidity
time frame: within the first 30 days after surgery
description: Complications after surgery
measure: Postoperative mortality
time frame: within the first 30 days after surgery
description: Death after surgery
measure: Postoperative recovery parameters
time frame: within the first 30 days after surgery
description: Complex of parameters describing the pattern of recovery after surgery (i.e. food tolerance, peristalsis, walking etc.)
measure: Pattern of lymph node metastasis based on pathology report
time frame: enrollment period
description: Number of lymph node with metastases related to number of lymph nodes studied in each group in the specimen
measure: CME quality
time frame: enrollment period
description: Ratio of good, satisfactory and unsatisfactory quality according to pathology report
measure: Lymph node yield
time frame: enrollment period
description: Number of lymph nodes removed according to pathology report
measure: Quality of life in patients after D2 and D3 lymph node dissection using questionnaire
time frame: enrollment period
description: CR29 and CR30 questionnaires by European Organization for Research and Treatment of Cancer
arm group label: D2 lymph node dissection
arm group type: Active Comparator
description: Colonic resection with D2 lymph node dissection
arm group label: D3 lymph node dissection
arm group type: Experimental
description: Colonic resection with D3 lymph node dissection
intervention type: Procedure
intervention name: Colonic resection with D2 lymph node dissection
description: Appropriate to the tumor location colonic resection is performed with D2 lymph node dissection
arm group label: D2 lymph node dissection
intervention type: Procedure
intervention name: Colonic resection with D3 lymph node dissection
description: Appropriate to the tumor location colonic resection is performed with D3 lymph node dissection
arm group label: D3 lymph node dissection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aleksei Karachun, Ph.D.
role: Study Chair
affiliation: N.N. Petrov Research Institute of Oncology, Surgical department of abdominal oncology, St. Petersburg, Russian Federation
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Russian Federation
citation: Karachun A, Petrov A, Panaiotti L, Voschinin Y, Ovchinnikova T. Protocol for a multicentre randomized clinical trial comparing oncological outcomes of D2 versus D3 lymph node dissection in colonic cancer (COLD trial). BJS Open. 2019 Mar 14;3(3):288-298. doi: 10.1002/bjs5.50142. eCollection 2019 Jun.
PMID: 31183444
citation: Karachun A, Panaiotti L, Chernikovskiy I, Achkasov S, Gevorkyan Y, Savanovich N, Sharygin G, Markushin L, Sushkov O, Aleshin D, Shakhmatov D, Nazarov I, Muratov I, Maynovskaya O, Olkina A, Lankov T, Ovchinnikova T, Kharagezov D, Kaymakchi D, Milakin A, Petrov A. Short-term outcomes of a multicentre randomized clinical trial comparing D2 versus D3 lymph node dissection for colonic cancer (COLD trial). Br J Surg. 2020 Apr;107(5):499-508. doi: 10.1002/bjs.11387. Epub 2019 Dec 24.
PMID: 31872869
responsible party type: Sponsor
mesh term: Colonic Neoplasms
mesh term: Neoplasms
sharing ipd: No
ipd description: We are not planning to share personal patient data