<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/NCT03033719</url>
  </required_header>
  <id_info>
    <org_study_id>K130901</org_study_id>
    <secondary_id>2016-A00312-49</secondary_id>
    <nct_id>NCT03033719</nct_id>
  </id_info>
  <brief_title>Colectomy for Cancer in the Elderly by Laparoscopy or Laparotomy</brief_title>
  <acronym>CELL</acronym>
  <official_title>Multicenter Randomized Trial Comparing Laparoscopy and Laparotomy for Colon Cancer Surgery in Patients Older Than 75 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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 compare the postoperative global morbidity between patients&#xD;
      who have been operated on for a colon cancer by laparotomy and those operated on by&#xD;
      laparoscopy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study is a national, multicenter, open-label randomized, 2-arm superiority trial.&#xD;
      Patients aged 75 years or older with uncomplicated colonic cancer or precancerous colonic&#xD;
      lesion non-endoscopically resectable, will be randomized to either colectomy by laparoscopy&#xD;
      or laparotomy. All patients that might be included will have a comprehensive geriatric&#xD;
      assessment performed within the 30 days before randomization with the following scores: MMS&#xD;
      (Mini Mental Score), ADL scale (Activities of Daily Living), IADL scale (Instrumental&#xD;
      Activities of Daily Living), GDS (Geriatric Depression Scale) and TGUG test (&quot;Timed&#xD;
      Get-Up-and-Go&quot; test).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 4, 2017</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">April 2020</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>Global postoperative morbidity in both arms</measure>
    <time_frame>At 30 days after the surgery</time_frame>
    <description>Postoperative morbidity is defined as any surgical or medical complications occurring up to 30 days after surgery. It will be collected using a standardized collection form during hospitalization and eventual subsequent consultations in case of patient discharge before then</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative mortality</measure>
    <time_frame>Evaluated at 30 days and at 90 days after the surgery</time_frame>
    <description>Death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of readmission</measure>
    <time_frame>Within the 30 days after discharge of the patient</time_frame>
    <description>Defined as any rehospitalization whatever the cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of examined lymph nodes</measure>
    <time_frame>At surgery</time_frame>
    <description>Quality of surgical resection : Number of examined lymph nodes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of resection (R0 or R1)</measure>
    <time_frame>At surgery</time_frame>
    <description>Quality of surgical resection : Type of resection (R0 or R1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pathological evaluation of mesocolic resection quality</measure>
    <time_frame>At surgery</time_frame>
    <description>Quality of surgical resection : Pathological evaluation of mesocolic resection quality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-C30)</measure>
    <time_frame>At randomization and three months postoperatively</time_frame>
    <description>Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-C30)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29)</measure>
    <time_frame>At randomization and three months postoperatively</time_frame>
    <description>Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini Mental State (MMS) Examination or Folstein test</measure>
    <time_frame>Before randomization and three months postoperatively</time_frame>
    <description>Evolution of geriatric scores : The Mini Mental State (MMS) Examination or Folstein test; (Comprehensive geriatric assessment performed by a geriatrician on each site)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Katz Activities of Daily Living (ADL) scale</measure>
    <time_frame>Before randomization and three months postoperatively</time_frame>
    <description>Evolution of geriatric scores :The Katz Activities of Daily Living (ADL) scale (Comprehensive geriatric assessment performed by a geriatrician on each site)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geriatric Depression Scale (GDS)</measure>
    <time_frame>Before randomization and three months postoperatively</time_frame>
    <description>Evolution of geriatric scores :The Geriatric Depression Scale (GDS) (Comprehensive geriatric assessment performed by a geriatrician on each site)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed Get-up-and-go (TGUG)</measure>
    <time_frame>Before randomization and three months postoperatively</time_frame>
    <description>Evolution of geriatric scores :The Timed Get-up-and-go (TGUG) test (Comprehensive geriatric assessment performed by a geriatrician on each site)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>To establish a specific molecular classification of colon cancer in the elderly from expression chips</measure>
    <time_frame>within the 15 years after the tumor sampling</time_frame>
    <description>To establish a specific molecular classification of colon cancer in the elderly from expression chips (Ancillary studies will be conducted from formalin fixed paraffin embedded (FFPE) tumor samples from our cohort)</description>
  </other_outcome>
  <other_outcome>
    <measure>To establish associations between molecular subtypes, the clinical and histological factors and relevant genetic alterations</measure>
    <time_frame>within the 15 years after the tumor sampling</time_frame>
    <description>To establish associations between molecular subtypes, the clinical and histological factors and relevant genetic alterations (Ancillary studies will be conducted from formalin fixed paraffin embedded (FFPE) tumor samples from our cohort)</description>
  </other_outcome>
  <other_outcome>
    <measure>To establish a possible link between these molecular subtypes and overall survival of patients</measure>
    <time_frame>within the 15 years after the tumor sampling</time_frame>
    <description>To establish a possible link between these molecular subtypes and overall survival of patients.&#xD;
(Ancillary studies will be conducted from formalin fixed paraffin embedded (FFPE) tumor samples from our cohort)</description>
  </other_outcome>
  <other_outcome>
    <measure>To compare our molecular classification with the different classifications already published in the literature on colorectal cance</measure>
    <time_frame>within the 15 years after the tumor sampling</time_frame>
    <description>To compare our molecular classification with the different classifications already published in the literature on colorectal cancer (Ancillary studies will be conducted from formalin fixed paraffin embedded (FFPE) tumor samples from our cohort)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">276</enrollment>
  <condition>Colonic Cancer</condition>
  <arm_group>
    <arm_group_label>Laparotomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Open surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laparoscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Minimally invasive surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparotomy</intervention_name>
    <description>Open surgery</description>
    <arm_group_label>Laparotomy</arm_group_label>
    <other_name>Open surgery</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopy</intervention_name>
    <description>Minimally invasive surgery</description>
    <arm_group_label>Laparoscopy</arm_group_label>
    <other_name>Minimally invasive surgery</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 75 years&#xD;
&#xD;
          2. Histologically proven colonic adenocarcinoma (&gt; 15 cm from the anal margin) or&#xD;
             precancerous colonic lesion non endoscopically resectable&#xD;
&#xD;
          3. Uncomplicated colonic tumor (no preoperative suspicion of invasion of adjacent&#xD;
             structures as assessed by CT-scan (cT4), no tumoral perforation, or tumoral&#xD;
             obstruction, or abscess, or hemorrhage)&#xD;
&#xD;
          4. No previous colonic cancer within the 5 last years&#xD;
&#xD;
          5. No peritoneal carcinosis on CT-scan&#xD;
&#xD;
          6. Patient able to fill in an auto-questionnaire alone or with some help&#xD;
&#xD;
          7. MMS (Mini Mental Score) ≥ 15&#xD;
&#xD;
          8. Given oral consent (formal informed consent is not required by French law for accepted&#xD;
             procedures)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Rectal cancer (≤ 15 cm from the anal margin)&#xD;
&#xD;
          2. Locally advanced (cT4) or complicated tumor requiring extended resection or emergency&#xD;
             surgery&#xD;
&#xD;
          3. Synchronous colonic cancer&#xD;
&#xD;
          4. - Scheduled need for synchronous intra-abdominal surgery, including surgery for liver&#xD;
             metastases&#xD;
&#xD;
          5. Absolute contraindications to general anesthesia or prolonged pneumoperitoneum&#xD;
&#xD;
          6. Patient not able to tolerate colon surgery according to the global comprehensive&#xD;
             geriatric assessment&#xD;
&#xD;
          7. Estimated life expectancy less than 6 months&#xD;
&#xD;
          8. Patient under guardianship&#xD;
&#xD;
          9. Other known active cancer (except nonmelanomatous skin cancer)&#xD;
&#xD;
         10. Patient not affiliated to the social security system&#xD;
&#xD;
         11. Previous colonic resection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gilles MANCEAU, M.D., PhD.,</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gilles MANCEAU, M.D., PhD.,</last_name>
    <phone>00331 42 17 56 51</phone>
    <email>gilles.manceau@aphp.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Groupe Hospitalier Pitié Salpêtrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gilles MANCEAU, MD</last_name>
      <email>gilles.manceau@aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>January 11, 2018</last_update_submitted>
  <last_update_submitted_qc>January 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colorectal Surgery</keyword>
  <keyword>Geriatrics</keyword>
  <keyword>Digestive Oncology</keyword>
  <keyword>Colon cancer</keyword>
  <keyword>Elderly patients</keyword>
  <keyword>Laparoscopy</keyword>
  <keyword>Laparotomy</keyword>
  <keyword>Morbidity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic 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/NCT03033719
org study id: K130901
secondary id: 2016-A00312-49
nct id: NCT03033719
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the postoperative global morbidity between patients
      who have been operated on for a colon cancer by laparotomy and those operated on by
      laparoscopy
The present study is a national, multicenter, open-label randomized, 2-arm superiority trial.
      Patients aged 75 years or older with uncomplicated colonic cancer or precancerous colonic
      lesion non-endoscopically resectable, will be randomized to either colectomy by laparoscopy
      or laparotomy. All patients that might be included will have a comprehensive geriatric
      assessment performed within the 30 days before randomization with the following scores: MMS
      (Mini Mental Score), ADL scale (Activities of Daily Living), IADL scale (Instrumental
      Activities of Daily Living), GDS (Geriatric Depression Scale) and TGUG test ("Timed
      Get-Up-and-Go" test).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Global postoperative morbidity in both arms
time frame: At 30 days after the surgery
description: Postoperative morbidity is defined as any surgical or medical complications occurring up to 30 days after surgery. It will be collected using a standardized collection form during hospitalization and eventual subsequent consultations in case of patient discharge before then
measure: Postoperative mortality
time frame: Evaluated at 30 days and at 90 days after the surgery
description: Death from any cause
measure: Rate of readmission
time frame: Within the 30 days after discharge of the patient
description: Defined as any rehospitalization whatever the cause
measure: Number of examined lymph nodes
time frame: At surgery
description: Quality of surgical resection : Number of examined lymph nodes
measure: Type of resection (R0 or R1)
time frame: At surgery
description: Quality of surgical resection : Type of resection (R0 or R1)
measure: Pathological evaluation of mesocolic resection quality
time frame: At surgery
description: Quality of surgical resection : Pathological evaluation of mesocolic resection quality
measure: Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-C30)
time frame: At randomization and three months postoperatively
description: Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-C30)
measure: Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29)
time frame: At randomization and three months postoperatively
description: Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29)
measure: Mini Mental State (MMS) Examination or Folstein test
time frame: Before randomization and three months postoperatively
description: Evolution of geriatric scores : The Mini Mental State (MMS) Examination or Folstein test; (Comprehensive geriatric assessment performed by a geriatrician on each site)
measure: Katz Activities of Daily Living (ADL) scale
time frame: Before randomization and three months postoperatively
description: Evolution of geriatric scores :The Katz Activities of Daily Living (ADL) scale (Comprehensive geriatric assessment performed by a geriatrician on each site)
measure: Geriatric Depression Scale (GDS)
time frame: Before randomization and three months postoperatively
description: Evolution of geriatric scores :The Geriatric Depression Scale (GDS) (Comprehensive geriatric assessment performed by a geriatrician on each site)
measure: Timed Get-up-and-go (TGUG)
time frame: Before randomization and three months postoperatively
description: Evolution of geriatric scores :The Timed Get-up-and-go (TGUG) test (Comprehensive geriatric assessment performed by a geriatrician on each site)
measure: To establish a specific molecular classification of colon cancer in the elderly from expression chips
time frame: within the 15 years after the tumor sampling
description: To establish a specific molecular classification of colon cancer in the elderly from expression chips (Ancillary studies will be conducted from formalin fixed paraffin embedded (FFPE) tumor samples from our cohort)
measure: To establish associations between molecular subtypes, the clinical and histological factors and relevant genetic alterations
time frame: within the 15 years after the tumor sampling
description: To establish associations between molecular subtypes, the clinical and histological factors and relevant genetic alterations (Ancillary studies will be conducted from formalin fixed paraffin embedded (FFPE) tumor samples from our cohort)
measure: To establish a possible link between these molecular subtypes and overall survival of patients
time frame: within the 15 years after the tumor sampling
description: To establish a possible link between these molecular subtypes and overall survival of patients.
(Ancillary studies will be conducted from formalin fixed paraffin embedded (FFPE) tumor samples from our cohort)
measure: To compare our molecular classification with the different classifications already published in the literature on colorectal cance
time frame: within the 15 years after the tumor sampling
description: To compare our molecular classification with the different classifications already published in the literature on colorectal cancer (Ancillary studies will be conducted from formalin fixed paraffin embedded (FFPE) tumor samples from our cohort)
arm group label: Laparotomy
arm group type: Active Comparator
description: Open surgery
arm group label: Laparoscopy
arm group type: Experimental
description: Minimally invasive surgery
intervention type: Procedure
intervention name: Laparotomy
description: Open surgery
arm group label: Laparotomy
other name: Open surgery
intervention type: Procedure
intervention name: Laparoscopy
description: Minimally invasive surgery
arm group label: Laparoscopy
other name: Minimally invasive surgery
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
last name: Gilles MANCEAU, M.D., PhD.,
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Gilles MANCEAU, M.D., PhD.,
phone: 00331 42 17 56 51
email: gilles.manceau@aphp.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Colonic Neoplasms
sharing ipd: No