<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/NCT01715363</url>
  </required_header>
  <id_info>
    <org_study_id>2011-003446-41</org_study_id>
    <secondary_id>2010/1676</secondary_id>
    <nct_id>NCT01715363</nct_id>
  </id_info>
  <brief_title>Feasibility of an Immediate Preoperative Chemotherapy Before Resection fo Colorectal Cancer</brief_title>
  <acronym>PRIMM</acronym>
  <official_title>Feasibility of an Immediate Preoperative Chemotherapy Before Resection of Colorectal Cancer and Research of Gene Expressions Changes Induced in the Tumor, Predictive of Chemotherapy Efficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gustave Roussy, Cancer Campus, Grand Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gustave Roussy, Cancer Campus, Grand Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to analyze the clinical tolerance of immediate preoperative&#xD;
      chemotherapy in terms of toxicity and perioperative morbidity and mortality&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment difficulties&#xD;
  </why_stopped>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical tolerance of immediate preoperative chemotherapy</measure>
    <time_frame>Assess up to 30 days after surgery</time_frame>
    <description>Clinical tolerance of immediate preoperative chemotherapy assessment is based on the post-operative complication rate in terms of morbidity and mortality.&#xD;
All the post-operative complications arising within 30 days after surgery will be registered and classified using the Clavien Dindo classification</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Patients With Colorectal Cancer With Unresectable Synchronous Metastasis in Whom Resection of the Primitive Tumour is Indicated</condition>
  <arm_group>
    <arm_group_label>FOLFOX + surgery + FOLFOX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Systemic chemotherapy (modified FOLFOX 4) 48 hours before surgery&#xD;
resection of the colorectal tumor during surgery&#xD;
Resumption of FOLFOX within the month after surgery (post operative administration of 4 course of treatment and assessment of the response)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <arm_group_label>FOLFOX + surgery + FOLFOX</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Folinic Acid</intervention_name>
    <arm_group_label>FOLFOX + surgery + FOLFOX</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluorouracile</intervention_name>
    <arm_group_label>FOLFOX + surgery + FOLFOX</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  colorectal metastatic adenocarcinoma (stage IV) with unresectables, measurables and&#xD;
             visibles secondary lesions&#xD;
&#xD;
          -  primitive tumor must be operate&#xD;
&#xD;
          -  patient age between 18 and 70&#xD;
&#xD;
          -  OMS status performance &lt; 2&#xD;
&#xD;
          -  life expectancy &gt; 12 weeks&#xD;
&#xD;
          -  hematologic function : PNN &gt;/= 1.5x10^9/L, platelets &gt;/= 100x10^9/L&#xD;
&#xD;
          -  hepatic function : bilirubin &lt;/= 1.5xLSN, AST and ALT &lt;/= 3xLSN, alcalin phosphatasis&#xD;
             &lt;/= 3xLSN&#xD;
&#xD;
          -  plasmatimic creatin &lt;/= 1.25xLSN&#xD;
&#xD;
          -  No previous chemotherapy or pelvic radiotherapy&#xD;
&#xD;
          -  men and women in age of procreate agreeing to use a contraception until 4 months after&#xD;
             the end of treatment for women and until 6 months for men&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  nonmetastatic forms&#xD;
&#xD;
          -  Colorectal tumor which requires preoperative radiotherapy&#xD;
&#xD;
          -  nonmeasurable metastasis based on RECIST criteria&#xD;
&#xD;
          -  previous chemotherapy for colorectal cancer&#xD;
&#xD;
          -  previous irradiation of the primitive tumour&#xD;
&#xD;
          -  specific indication against the treatment studied&#xD;
&#xD;
          -  Patient considered as inoperable for physiological or carcinologic reasons&#xD;
&#xD;
          -  Pregnant or breast feeding women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Diane GOERE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gustave Roussy, Cancer Campus, Grand Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <state>Val de Marne</state>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>February 9, 2016</last_update_submitted>
  <last_update_submitted_qc>February 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 10, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leucovorin</mesh_term>
    <mesh_term>Folic Acid</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Levoleucovorin</mesh_term>
  </intervention_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/NCT01715363
org study id: 2011-003446-41
secondary id: 2010/1676
nct id: NCT01715363
lead sponsor: 
has dmc: No
The purpose of this study is to analyze the clinical tolerance of immediate preoperative
      chemotherapy in terms of toxicity and perioperative morbidity and mortality
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical tolerance of immediate preoperative chemotherapy
time frame: Assess up to 30 days after surgery
description: Clinical tolerance of immediate preoperative chemotherapy assessment is based on the post-operative complication rate in terms of morbidity and mortality.
All the post-operative complications arising within 30 days after surgery will be registered and classified using the Clavien Dindo classification
arm group label: FOLFOX + surgery + FOLFOX
arm group type: Experimental
description: Systemic chemotherapy (modified FOLFOX 4) 48 hours before surgery
resection of the colorectal tumor during surgery
Resumption of FOLFOX within the month after surgery (post operative administration of 4 course of treatment and assessment of the response)
intervention type: Drug
intervention name: Oxaliplatin
arm group label: FOLFOX + surgery + FOLFOX
intervention type: Drug
intervention name: Folinic Acid
arm group label: FOLFOX + surgery + FOLFOX
intervention type: Drug
intervention name: Fluorouracile
arm group label: FOLFOX + surgery + FOLFOX
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Diane GOERE, MD
role: Principal Investigator
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Leucovorin
mesh term: Folic Acid
mesh term: Oxaliplatin
mesh term: Levoleucovorin