<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/NCT02967289</url>
  </required_header>
  <id_info>
    <org_study_id>UC-0110/1609_PRODIGE52/UCGI29</org_study_id>
    <secondary_id>2016-001491-29</secondary_id>
    <nct_id>NCT02967289</nct_id>
  </id_info>
  <brief_title>IRinotecan and Oxaliplatin for Colon Cancer in Adjuvant Setting</brief_title>
  <acronym>IROCAS</acronym>
  <official_title>A Phase III, Randomised, International Trial Comparing mFOLFIRINOX Triplet Chemotherapy to mFOLFOX for High-risk Stage III Colon Cancer in Adjuvant Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNICANCER</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Cancer Trials Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>GONO GROUP</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>UNICANCER</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>
      The trial is a phase III, multicenter, open-labeled randomized trial comparing the&#xD;
      association of 5-fluorouracil (5-FU), folinic acid, irinotecan, and oxaliplatin (mFOLFIRINOX)&#xD;
      versus oxaliplatin, folinic acid, and 5-FU (mFOLFOX 6) chemotherapy protocols in patients&#xD;
      with high-risk stage III colon cancer in the adjuvant setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After inclusion and non-inclusion criteria have been fulfilled and the patient consent has&#xD;
      been obtained, the patient will be included and randomized in the trial. The maximum delay&#xD;
      allowed between the signature of the consent form by the patient and the randomization in the&#xD;
      study is 28 days.&#xD;
&#xD;
      The randomization procedure using minimization method will allocate the treatments&#xD;
      mFOLFIRINOX or mFOLFOX 6 with a 1:1 ratio, and will be stratified by the following criteria:&#xD;
&#xD;
        -  Perforation or urgent surgery versus no perforation and no urgent surgery.&#xD;
&#xD;
        -  T1-T3N2 vs T4aN1 versus T4bN1 versus T4N2.&#xD;
&#xD;
        -  Right colon (right of splenic flexure) vs left colon.&#xD;
&#xD;
        -  Country (France vs Canada vs Italy). Patient eligible and who have signed the informed&#xD;
           consent will be randomized in one of the two treatments arms and will receive every 14&#xD;
           days their treatment for a duration of 12 cycles.&#xD;
&#xD;
      Arm A: mFOLFIRINOX Arm B: mFOLFOX 6&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 27, 2017</start_date>
  <completion_date type="Anticipated">June 2027</completion_date>
  <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
  <phase>Phase 3</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>The trial is a phase III, multicenter, open-labeled randomized trial comparing the association 5-fluorouracil, folinic acid, irinotecan and oxaliplatin (mFOLFIRINOX) versus oxaliplatin, folinic acid, 5FU (mFOLFOX 6) chemotherapy protocols in patients with high-risk stage III colon cancer in the adjuvant setting.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The primary end-point is the Disease Free Survival (DFS) at 3 years, defined as the time from the date of randomization up to the date of:&#xD;
first local, regional or distant relapse;&#xD;
second colorectal cancer;&#xD;
death from any cause included treatment-related death. Other primary cancer (except second primary colorectal) will be ignored. Second primary cancer will be recorded to have the opportunity of evaluating other definition of DFS.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Disease Free Survival (DFS)</measure>
    <time_frame>3 YEARS after inclusion</time_frame>
    <description>DFS :&#xD;
defined as the time from the date of randomization up to the date of:&#xD;
first local, regional or distant relapse;&#xD;
second colorectal cancer;&#xD;
death from any cause included treatment-related death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease Free Survival</measure>
    <time_frame>2 YEARS after inclusion</time_frame>
    <description>DFS :&#xD;
defined as the time from the date of randomization up to the date of:&#xD;
first local, regional or distant relapse;&#xD;
second colorectal cancer;&#xD;
death from any cause included treatment-related death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>5 YEARS after inclusion</time_frame>
    <description>Overall Survival (OS) is defined as the time from the date of randomization to the date of documented death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>2 YEARS after inclusion</time_frame>
    <description>Safety of the study treatment will be assessed on occurrence of Adverse Events (AEs), intake of concomitant treatments, per-treatment arising changes in physical examination, vital signs (blood pressure, pulse rate and body temperature), ECG, and clinical laboratory tests (biochemistry, haematology). Safety parameters will be graded based on NCI CTCAE v4.03 classification.&#xD;
The following parameters will be particularly followed:&#xD;
The incidence of haematological toxicities (grade 3-4, in particular neutropenia and febrile neutropenia); The incidence of GI toxicities, in particular diarrhea; The incidence of peripheral neuropathy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">792</enrollment>
  <condition>Colon Cancer (High-risk Stage III: pT4N1 or pT1 to 4 N2)</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>mFOLFIRINOX Folfox Protocol + Irinotecan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>mFOLFOX 6 Folfox Protocol</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Irinotecan</intervention_name>
    <description>every 14 days, 12 cycles, 24 weeks, new cycle beginning on day 15: irinotecan (Campto®) 180 mg/m² on D1, IV infusion over 90 minutes to begin 30 min after folinic acid infusion is started</description>
    <arm_group_label>Arm A</arm_group_label>
    <other_name>Campto</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Folfox Protocol</intervention_name>
    <description>every 14 days, 12 cycles, 24 weeks, new cycle beginning on day 15: oxaliplatin (Eloxatin®) 85 mg/m² on D1, IV infusion over 2 hours, followed by folinic acid 400 mg/m² (racemic mixture) (or 200 mg/m² if L-folinic acid) IV infusion over 2 hours 5-FU 2400 mg/m²/h IV continuous infusion over 46 hours starting at the end of folinic acid infusion</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
    <other_name>acid folinic + oxaliplatine + 5-FU</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        DIAGNOSIS AND INCLUSION CRITERIA:&#xD;
&#xD;
          1. Patient ≥18 years and &lt; 75 years&#xD;
&#xD;
          2. Patient ≥18 years and &lt;71 years must have an ECOG ≤1 - Patients ≥71 years and &lt; 75&#xD;
             years must have an ECOG = 0&#xD;
&#xD;
          3. Pathologically confirmed high-risk stage III colon adenocarcinoma, restricted to pT4N1&#xD;
             or pT1-4N2 tumor.&#xD;
&#xD;
          4. Curative R0 surgical resection.&#xD;
&#xD;
          5. Patients who have undergone surgery for colon cancer, defined as a tumor location &gt;12&#xD;
             cm from the anal verge by endoscopy and/or above the peritoneal reflection at surgery&#xD;
             (high rectum), without gross or microscopic evidence of residual disease after surgery&#xD;
             with curative intent&#xD;
&#xD;
          6. Start of study drug treatment has to be performed less than 56 days after surgery.&#xD;
&#xD;
          7. No prior chemotherapy.&#xD;
&#xD;
          8. No prior abdominal or pelvic irradiation.&#xD;
&#xD;
          9. Patient with adequate organ function:&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) ≥ 2 x 109/L&#xD;
&#xD;
               -  Haemoglobin ≥9 g/dL&#xD;
&#xD;
               -  Platelets (PTL) ≥100 x 109/L&#xD;
&#xD;
               -  AST/ALT ≤2.5 x ULN&#xD;
&#xD;
               -  Alkaline phosphatase ≤2.5 x ULN&#xD;
&#xD;
               -  Total Bilirubin ≤1.5 x ULN (Upper Limit of Normal)&#xD;
&#xD;
               -  Creatinine clearance ≥50 mL/min (Cockcroft and Gault formula)&#xD;
&#xD;
               -  Kalemia, magnesemia, calcemia ≥ 1 LLN (Lower Limit of Normal)&#xD;
&#xD;
               -  Carcinoembryonic antigen (CEA) ≤10ng/mL after surgery (during screening period)&#xD;
&#xD;
         10. Adequate contraception if applicable.&#xD;
&#xD;
         11. Patient able and willing to comply with study procedures as per protocol&#xD;
&#xD;
         12. Patient able to understand and willing to sign and date the written voluntary informed&#xD;
             consent form at screening visit prior to any protocol-specific procedures&#xD;
&#xD;
         13. Public or private health insurance coverage&#xD;
&#xD;
         14. Life expectancy of &gt; or = at 5 years&#xD;
&#xD;
         15. Uracilemia &lt; 16 ng/ml (only for french centers)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Major surgical procedure, open biopsy or significant traumatic injury within 28 days&#xD;
             prior to study treatment start. Incompletely healed wounds or anticipation of the need&#xD;
             for major surgical procedure during the course of the study&#xD;
&#xD;
          2. Metastatic disease&#xD;
&#xD;
          3. Presence of inflammatory bowel disease and/or ileus&#xD;
&#xD;
          4. Known hypersensitivity reaction to any of the components of study treatments.&#xD;
&#xD;
          5. Pregnancy (absence to be confirmed by β-hCG test) or breast-feeding period&#xD;
&#xD;
          6. Clinically relevant coronary artery disease or history of myocardial infarction in the&#xD;
             last 12 months, or high risk of uncontrolled arrhythmia (for men: QTc ≥450 msec, for&#xD;
             women: QTc ≥470 msec)&#xD;
&#xD;
          7. Previous malignancy in the last 5 years except curative treated basal cell carcinoma&#xD;
             of the skin and/or in situ carcinoma of the cervix&#xD;
&#xD;
          8. Medical, geographical, sociological, psychological or legal conditions that would not&#xD;
             permit the patient to complete the study or sign informed consent&#xD;
&#xD;
          9. History or current evidence on physical examination of central nervous system disease&#xD;
             or peripheral neuropathy ≥ grade 1 Common Toxicity Criteria for Adverse Events (CTCAE)&#xD;
             v4.03.&#xD;
&#xD;
         10. Any significant disease which, in the investigator's opinion, would exclude the&#xD;
             patient from the study.&#xD;
&#xD;
         11. Patient with a DPD deficiency or UGT1A1 homozygous 7/7; the test should be done for&#xD;
             all patients before 5-FU administration, according to ANSM communication regarding&#xD;
             recommendation about high risk of no testing DPD in patient before 5-FU&#xD;
             administration; (Appendices 8 to 11).&#xD;
&#xD;
         12. Patients already included in another therapeutic trial involving an experimental drug&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jaafar BENNOUNA, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Hôpital FOCH, SURESNES</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Julien TAIEB, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Hôpital Européen Georges-Pompidou, PARIS</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thierry ANDRE, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>AP-HP Hôpital Saint-Antoine, PARIS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The PEI Cancer Treatment Centre Queen Elizabeth Hospital</name>
      <address>
        <city>Charlottetown</city>
        <state>Prince Edward Island</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Charles LeMoyne</name>
      <address>
        <city>Greenfield Park</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier de l'Université de Montréal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allan Blair Cancer Centre</name>
      <address>
        <city>Regina</city>
        <state>Saskatchewan</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie de l'Ouest -site Paul Papin</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHD de Vendée</name>
      <address>
        <city>La Roche-sur-Yon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch Emile Roux</name>
      <address>
        <city>Le Puy-en-Velay</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospices civils de Lyon - Hôpital Edouard Herriot</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital privé Jean Mermoz</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icm Val D'Aurelle</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie de l'Ouest -site René Gauducheau</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Européen Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Antoine</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Annecy Genevois</name>
      <address>
        <city>Pringy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Jean Godinot</name>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHP Saint Grégoire</name>
      <address>
        <city>Saint Gregoire</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique de la Côte d'Emeraude</name>
      <address>
        <city>Saint-Malo</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>November 9, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>August 30, 2023</last_update_submitted>
  <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>colon</keyword>
  <keyword>cancer</keyword>
  <keyword>stage 3</keyword>
  <keyword>high-risk</keyword>
  <keyword>mFolfirinox</keyword>
  <keyword>mFolfox6</keyword>
  <keyword>adjuvant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irinotecan</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.</ipd_time_frame>
    <ipd_access_criteria>Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.</ipd_access_criteria>
    <ipd_url>https://www.google.com/maps/d/u/2/viewer?mid=1z7kLXwQjEMgrBzzyYNwijVdgXMIXqVIy&amp;ll=35.52580937282327%2C-54.931599049999996&amp;z=3</ipd_url>
  </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/NCT02967289
org study id: UC-0110/1609_PRODIGE52/UCGI29
secondary id: 2016-001491-29
nct id: NCT02967289
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The trial is a phase III, multicenter, open-labeled randomized trial comparing the
      association of 5-fluorouracil (5-FU), folinic acid, irinotecan, and oxaliplatin (mFOLFIRINOX)
      versus oxaliplatin, folinic acid, and 5-FU (mFOLFOX 6) chemotherapy protocols in patients
      with high-risk stage III colon cancer in the adjuvant setting.
After inclusion and non-inclusion criteria have been fulfilled and the patient consent has
      been obtained, the patient will be included and randomized in the trial. The maximum delay
      allowed between the signature of the consent form by the patient and the randomization in the
      study is 28 days.

      The randomization procedure using minimization method will allocate the treatments
      mFOLFIRINOX or mFOLFOX 6 with a 1:1 ratio, and will be stratified by the following criteria:

        -  Perforation or urgent surgery versus no perforation and no urgent surgery.

        -  T1-T3N2 vs T4aN1 versus T4bN1 versus T4N2.

        -  Right colon (right of splenic flexure) vs left colon.

        -  Country (France vs Canada vs Italy). Patient eligible and who have signed the informed
           consent will be randomized in one of the two treatments arms and will receive every 14
           days their treatment for a duration of 12 cycles.

      Arm A: mFOLFIRINOX Arm B: mFOLFOX 6
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The trial is a phase III, multicenter, open-labeled randomized trial comparing the association 5-fluorouracil, folinic acid, irinotecan and oxaliplatin (mFOLFIRINOX) versus oxaliplatin, folinic acid, 5FU (mFOLFOX 6) chemotherapy protocols in patients with high-risk stage III colon cancer in the adjuvant setting.
primary purpose: Treatment
masking: None (Open Label)
masking description: The primary end-point is the Disease Free Survival (DFS) at 3 years, defined as the time from the date of randomization up to the date of:
first local, regional or distant relapse;
second colorectal cancer;
death from any cause included treatment-related death. Other primary cancer (except second primary colorectal) will be ignored. Second primary cancer will be recorded to have the opportunity of evaluating other definition of DFS.
measure: Disease Free Survival (DFS)
time frame: 3 YEARS after inclusion
description: DFS :
defined as the time from the date of randomization up to the date of:
first local, regional or distant relapse;
second colorectal cancer;
death from any cause included treatment-related death.
measure: Disease Free Survival
time frame: 2 YEARS after inclusion
description: DFS :
defined as the time from the date of randomization up to the date of:
first local, regional or distant relapse;
second colorectal cancer;
death from any cause included treatment-related death.
measure: Overall Survival
time frame: 5 YEARS after inclusion
description: Overall Survival (OS) is defined as the time from the date of randomization to the date of documented death from any cause
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
time frame: 2 YEARS after inclusion
description: Safety of the study treatment will be assessed on occurrence of Adverse Events (AEs), intake of concomitant treatments, per-treatment arising changes in physical examination, vital signs (blood pressure, pulse rate and body temperature), ECG, and clinical laboratory tests (biochemistry, haematology). Safety parameters will be graded based on NCI CTCAE v4.03 classification.
The following parameters will be particularly followed:
The incidence of haematological toxicities (grade 3-4, in particular neutropenia and febrile neutropenia); The incidence of GI toxicities, in particular diarrhea; The incidence of peripheral neuropathy.
arm group label: Arm A
arm group type: Experimental
description: mFOLFIRINOX Folfox Protocol + Irinotecan
arm group label: Arm B
arm group type: Active Comparator
description: mFOLFOX 6 Folfox Protocol
intervention type: Drug
intervention name: Irinotecan
description: every 14 days, 12 cycles, 24 weeks, new cycle beginning on day 15: irinotecan (Campto®) 180 mg/m² on D1, IV infusion over 90 minutes to begin 30 min after folinic acid infusion is started
arm group label: Arm A
other name: Campto
intervention type: Drug
intervention name: Folfox Protocol
description: every 14 days, 12 cycles, 24 weeks, new cycle beginning on day 15: oxaliplatin (Eloxatin®) 85 mg/m² on D1, IV infusion over 2 hours, followed by folinic acid 400 mg/m² (racemic mixture) (or 200 mg/m² if L-folinic acid) IV infusion over 2 hours 5-FU 2400 mg/m²/h IV continuous infusion over 46 hours starting at the end of folinic acid infusion
arm group label: Arm A
arm group label: Arm B
other name: acid folinic + oxaliplatine + 5-FU
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jaafar BENNOUNA, Professor
role: Study Chair
affiliation: Hôpital FOCH, SURESNES
last name: Julien TAIEB, Professor
role: Study Chair
affiliation: Hôpital Européen Georges-Pompidou, PARIS
last name: Thierry ANDRE, Professor
role: Study Chair
affiliation: AP-HP Hôpital Saint-Antoine, PARIS
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: France
responsible party type: Sponsor
mesh term: Colonic Neoplasms
mesh term: Irinotecan
sharing ipd: Yes
ipd description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.
ipd access criteria: Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.
ipd url: https://www.google.com/maps/d/u/2/viewer?mid=1z7kLXwQjEMgrBzzyYNwijVdgXMIXqVIy&ll=35.52580937282327%2C-54.931599049999996&z=3