<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/NCT03828227</url>
  </required_header>
  <id_info>
    <org_study_id>COLAGE C18-01 PRODIGE 66</org_study_id>
    <nct_id>NCT03828227</nct_id>
  </id_info>
  <brief_title>QoL in mCRC Elderly Patients Receiving First-line Therapy Based on Simplified Geriatric Parameters.</brief_title>
  <acronym>COLAGE</acronym>
  <official_title>Phase III Study to Evaluate the Quality of Life in Elderly Patients With Metastatic Colorectal Cancer Receiving First-line Therapy Based on Simplified Geriatric Parameters.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GERCOR - Multidisciplinary Oncology Cooperative Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GERCOR - Multidisciplinary Oncology Cooperative Group</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>
      A national, multicenter, open-label, randomized phase III study. The trial aim is to&#xD;
      determine the best therapeutic strategies according with the HRQoL.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Treatment cohort will be determined based on three parameters:&#xD;
&#xD;
        -  Serum albumin level at baseline,&#xD;
&#xD;
        -  ECOG Performance Status,&#xD;
&#xD;
        -  Mini GDS.&#xD;
&#xD;
      The &quot;Candidate&quot; group will be defined according to (all the following criteria must be&#xD;
      fulfilled):&#xD;
&#xD;
        -  Serum albumin level ≥ 30g/L,&#xD;
&#xD;
        -  ECOG PS 0-1 (whatever mini GDS score) or ECOG PS 2 with mini GDS 0 (ie, no depression).&#xD;
&#xD;
      The &quot;Non-candidate&quot; cohort group will be defined according to (at least one of those&#xD;
      parameters is fulfilled):&#xD;
&#xD;
        -  Serum albumin level &lt; 30g/L.&#xD;
&#xD;
        -  And/ or ECOG PS 2 and mini GDS ≥ 1 (ie, depression).&#xD;
&#xD;
      Patients in the &quot;Candidate group&quot; will be randomized to:&#xD;
&#xD;
        -  OPTIMOX bevacizumab (arm A),&#xD;
&#xD;
        -  Capecitabine + bevacizumab (arm B), in priority followed by FOLFOX-bevacizumab at first&#xD;
           progression.&#xD;
&#xD;
      Patients in the &quot;Non-candidate&quot; group cohort&#xD;
&#xD;
      - Not randomized, follow-up patients receiving: capecitabine + bevacizumab&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 7, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Health-related quality of life (HRQoL) at 6 months in the &quot;candidate group&quot;.</measure>
    <time_frame>At 6 months</time_frame>
    <description>Improvement of HRQoL at 6 months by 10 points compared to the score at inclusion on the following targeted dimensions: emotional functioning (4 items) and global health (2 items) (score from 6-30 with higher values representing better quality of life).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients amenable to second-line therapy.</measure>
    <time_frame>until 58 months</time_frame>
    <description>Proportion of patients amenable to second-line therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patient amenable to surgery and/or locoregional therapy.</measure>
    <time_frame>until 58 months</time_frame>
    <description>Proportion of patients amenable to salvage surgery and/or locoregional therapy (e.g., radiofrequency ablation, stereotactic radiotherapy, …).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>until 58 months</time_frame>
    <description>PFS is defined as time from date of first dose of study treatment to date of first documented PD or death due to any cause determined by the Investigator assessment in accordance to RECIST 1.1. Alive patients without progression will be censored at the last tumor assessment, either during study treatment period or during follow-up period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Until 58 months</time_frame>
    <description>OS defined as the time between the date of the first dose of study treatment and the death date. Alive patients will be censored at the last date known to be alive, either during study treatment period or during follow-up period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other dimensions of health-related quality of life (HRQoL) and longitudinal HRQoL</measure>
    <time_frame>Until 58 months</time_frame>
    <description>HRQoL: all other dimensions of the QLQC-30 and QLQELD-14 questionnaires, and longitudinal analyses of the QLQC-30 and QLQELD-14 elderly specific module integrating all measurement times.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of instrumental activities of daily living (IADL) as prognostic factor for overall survival (OS).</measure>
    <time_frame>Until 58 months</time_frame>
    <description>IADL as prognostic factor for overall survival (OS) and treatment toxicity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>G8 score at baseline.</measure>
    <time_frame>until 58 months</time_frame>
    <description>To determine G8 score at baseline and to correlate the candidate group and the non-candidate group according to G8 score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance status geriatric (PSG) score.</measure>
    <time_frame>until 58 months</time_frame>
    <description>External analysis of PSG score as predictive for treatment efficacy: PFS and OS.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">188</enrollment>
  <condition>Elderly Patients</condition>
  <condition>Metastatic Colorectal Cancer</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>&quot;Candidate group&quot; OPTIMOX plus bevacizumab (Arm A)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with :&#xD;
Serum albumin level ≥ 30g/L,&#xD;
ECOG PS 0-1 (whatever mini GDS score) or ECOG PS 2 with mini GDS 0 (ie, no depression).&#xD;
Adapted FOLFOX7 (aFOLFOX7)-bevacizumab for 6 cycles and then Adapted LV5FU2 (aLV5FU2)-bevacizumab (until progression or or unacceptable limiting toxicity)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>&quot;Candidate group&quot; - Capecitabine-bevacizumab (Arm B)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with :&#xD;
Serum albumin level ≥ 30g/L,&#xD;
ECOG PS 0-1 (whatever mini GDS score) or ECOG PS 2 with mini GDS 0 (ie, no depression).&#xD;
This treatment regimen will be given until disease progression (PD) or unacceptable limiting toxicity, as follows:</description>
  </arm_group>
  <arm_group>
    <arm_group_label>&quot;Non candidate group&quot; - Capecitabine-bevacizumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with:&#xD;
Serum albumin level &lt; 30g/L.&#xD;
And/ or ECOG PS 2 and mini GDS ≥ 1 (ie, depression).&#xD;
This treatment regimen will be given until disease progression (PD) or unacceptable limiting toxicity, as follows:</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OPTIMOX-bevacizumab</intervention_name>
    <description>Induction Adapted FOLFOX7 (aFOLFOX7)-bevacizumab for 6 cycles (3 months)&#xD;
Bevacizumab: 5 mg/kg IV (day 1, every 2 weeks [q2w]),&#xD;
Folinic acid (FA): 400 mg/m² IV/2h (day 1, q2w),&#xD;
Oxaliplatin: 85 mg/m² IV/2h (day 1, q2w),&#xD;
5-fluorouracil (5-FU) continuous infusion 2400 mg/m² IV/46h (day 1-2, q2w),&#xD;
No 5-FU bolus.&#xD;
then Maintenance Adapted LV5FU2 (aLV5FU2)-bevacizumab (until progression or or unacceptable limiting toxicity)&#xD;
Bevacizumab: 5 mg/kg IV (day 1, q2w),&#xD;
FA: 400 mg/m² IV/2h (day 1, q2w),&#xD;
5-FU continuous infusion 2400 mg/m² IV/46h (day 1-2, q2w)&#xD;
No 5-FU bolus</description>
    <arm_group_label>&quot;Candidate group&quot; OPTIMOX plus bevacizumab (Arm A)</arm_group_label>
    <other_name>Folinic acid (FA)-5-fluorouracil (5-FU)-oxaliplatin [OPTIMOX]</other_name>
    <other_name>Avastin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine plus bevacizumab</intervention_name>
    <description>Bevacizumab: 7.5 mg/kg intravenous infusion [IV] (day 1; q3w),&#xD;
Capecitabine: 1000 mg/m² orally twice a day (day 1 through day 14, q3w).</description>
    <arm_group_label>&quot;Candidate group&quot; - Capecitabine-bevacizumab (Arm B)</arm_group_label>
    <arm_group_label>&quot;Non candidate group&quot; - Capecitabine-bevacizumab</arm_group_label>
    <other_name>capecitabine</other_name>
    <other_name>Avastin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed and dated informed consent, and willing and able to comply with protocol&#xD;
             requirements,&#xD;
&#xD;
          2. Histologically proven colorectal adenocarcinoma,&#xD;
&#xD;
          3. Confirmed metastatic disease,&#xD;
&#xD;
          4. Patients with no detected dihydropyridine dehydrogenase (DPD) deficiency,&#xD;
&#xD;
          5. No prior therapy for metastatic disease (in case of previous adjuvant chemotherapy,&#xD;
             interval between the end of chemotherapy and relapse must be &gt; 6 months for&#xD;
             fluoropyrimidine alone or &gt; 12 months for oxaliplatin-based chemotherapy,&#xD;
&#xD;
          6. Duly documented unresectable metastatic disease i.e., not suitable for complete&#xD;
             carcinological surgical resection,&#xD;
&#xD;
          7. Age ≥ 75 years,&#xD;
&#xD;
          8. ECOG PS 0-2,&#xD;
&#xD;
          9. Hematological status: neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L, and&#xD;
             hemoglobin &gt; 9 g/dL,&#xD;
&#xD;
         10. Adequate renal function: serum creatinine level &lt; 150 µmol/l, and creatinine clearance&#xD;
             (Cockcroft and Gault or MDRD formula &gt; 30 mL/min),&#xD;
&#xD;
         11. Adequate liver function: total bilirubin level &lt; 1.5 x upper normal limit (ULN), serum&#xD;
             alkaline phosphatase (ALP) level &lt; 5 x ULN,&#xD;
&#xD;
         12. Proteinuria &lt; 2+ (dipstick urinalysis) or ≤ 1g/24h,&#xD;
&#xD;
         13. Regular follow-up feasible. The registered patient must be treated and followed at the&#xD;
             participating center,&#xD;
&#xD;
         14. Registration in France with the French National Health Care System (including&#xD;
             dispositive PUMA (protection Universelle Maladie).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History or evidence upon physical examination of CNS metastasis (e.g. non- irradiated&#xD;
             CNS metastasis, seizure not controlled with standard medical therapy), unless&#xD;
             adequately treated,&#xD;
&#xD;
          2. Neuropathy grade &gt; 1,&#xD;
&#xD;
          3. Patient with known dihydropyridine dehydrogenase (DPD) deficiency or history of severe&#xD;
             and unexpected reactions to a fluoropyrimidine-containing regimen, or in case of&#xD;
             clinically significant active heart disease or myocardial infarction within 6 months&#xD;
             or if patient treated with sorivudine or its clinically related analogues, such as&#xD;
             brivudine&#xD;
&#xD;
          4. Uncontrolled hypercalcemia,&#xD;
&#xD;
          5. Uncontrolled hypertension (defined as systolic blood pressure &gt; 150 mmHg and/or&#xD;
             diastolic blood pressure &gt; 100 mmHg), or history of hypertensive crisis, or&#xD;
             hypertensive encephalopathy,&#xD;
&#xD;
          6. Medical history of other concomitant or previous malignant disease, except adequately&#xD;
             treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of&#xD;
             the skin, or cancer in complete remission for ≥ 5 years,&#xD;
&#xD;
          7. History of arterial thrombotic and/or embolic event (e.g. myocardial infarction,&#xD;
             stroke…) within 6 months prior to randomization,&#xD;
&#xD;
          8. History of abdominal fistula, gastrointestinal (GI) perforation, intra-abdominal&#xD;
             abscess or active GI bleeding within 6 months prior to randomization,&#xD;
&#xD;
          9. History or evidence of inherited bleeding diathesis or significant coagulopathy at&#xD;
             risk of bleeding,&#xD;
&#xD;
         10. Major surgery (open biopsy, surgical resection, wound revision or any other major&#xD;
             surgery involving entry into body cavity) or significant traumatic injury within the&#xD;
             last 28 days prior to randomization, and/or minor surgical procedure including&#xD;
             placement of a vascular device within 2 days of first study treatment,&#xD;
&#xD;
         11. Concomitant administration of prophylactic phenytoin,&#xD;
&#xD;
         12. Treatment with sorivudine or its chemically related analogues, such as brivudine,&#xD;
&#xD;
         13. Patients with known allergy/hypersensitivity to any component of study drugs&#xD;
&#xD;
         14. Concomitant unplanned anti-tumor treatment,&#xD;
&#xD;
         15. Participation in another clinical trial with any investigational drug within 30 days&#xD;
             prior to randomization,&#xD;
&#xD;
         16. Other serious and uncontrolled non-malignant disease,&#xD;
&#xD;
         17. Patient under guardianship, curatorship or under the protection of justice&#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>Elisabeth CAROLA, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCOG Picardie Groupe Hospitalier Public du Sud de l'Oise (GHPSO)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elisabeth CAROLA, MD</last_name>
    <phone>0140298500</phone>
    <email>Elisabeth.Carola@ghpso.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marie-Line GARCIA LARNICOL, MD</last_name>
    <phone>0140298500</phone>
    <email>marie-line.garcia-larnicol@gercor.com.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CH Abbeville</name>
      <address>
        <city>Abbeville</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Mathieu PAUWELS, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Amiens Hôpital sud</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Vincent HAUTEFEUILLE, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Clinique de l'Europe</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Michel GOZY, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CH Beauvais</name>
      <address>
        <city>Beauvais</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Fayçal HOCINE, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Duchenne</name>
      <address>
        <city>Boulogne-sur-Mer</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vincent BOURGEOIS, MD</last_name>
    </contact>
    <investigator>
      <last_name>Vincent BOURGEOIS, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier de Cannes</name>
      <address>
        <city>Cannes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laurence SAUDES, MD</last_name>
    </contact>
    <investigator>
      <last_name>Laurence SAUDES, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CH Compiègne Noyon</name>
      <address>
        <city>Compiègne</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Virginie SEBBAGH, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UCOG Picardie Groupe Hospitalier</name>
      <address>
        <city>Creil</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elisabeth CAROLA, MD</last_name>
    </contact>
    <investigator>
      <last_name>Elisabeth CAROLA, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Christophe TOURNIGAND, MD</last_name>
    </contact>
    <investigator>
      <last_name>Christophe TOURNIGAND, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre geroges François Leclerc</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Leïla BENGRINE, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut Daniel Hollard</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Christine REBISCHUNG, MD</last_name>
    </contact>
    <investigator>
      <last_name>Cécile LEYRONNAS, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut Hospitalier Franco-Britannique</name>
      <address>
        <city>Levallois-Perret</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Honorine GERVAIS, MD</last_name>
    </contact>
    <investigator>
      <last_name>Honorine GERVAIS, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Privé Jean Mermoz</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Léa CLAVEL, MD</last_name>
    </contact>
    <investigator>
      <last_name>Léa CLAVEL, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut Paoli-Calmettes</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Pauline RIES-GUYE, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CH Sud Ile de France</name>
      <address>
        <city>Melun</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Hélène DALL'OSTO, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CH Mont de Marsan</name>
      <address>
        <city>Mont-de-Marsan</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jérome DAUBA, MD</last_name>
    </contact>
    <investigator>
      <last_name>Jérôme DAUBA, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Antoine Lacassagne</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Eric FRANCOIS, MD</last_name>
    </contact>
    <investigator>
      <last_name>Eric FRANCOIS, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital des Diaconnesses Croix Saint Simon</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine DELBALDO</last_name>
    </contact>
    <investigator>
      <last_name>Catherine DELBALDO, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Antoine</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Daniel LOPEZ TRABADA ATAZ, Md</last_name>
    </contact>
    <investigator>
      <last_name>Daniel LOPEZ TRABADA ATAZ, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut Mutualiste Montsouris</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Christophe LOUVET, MD</last_name>
    </contact>
    <investigator>
      <last_name>Christophe LOUVET, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CH Annecy Genevois</name>
      <address>
        <city>Pringy</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Mathieu BACONNIER, MD</last_name>
    </contact>
    <investigator>
      <last_name>Mathieu BACONNIER, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CH Saint Malo</name>
      <address>
        <city>Saint-Malo</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Anaïs BODERE, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>June 27, 2023</last_update_submitted>
  <last_update_submitted_qc>June 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>chemotherapy</keyword>
  <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>Bevacizumab</mesh_term>
    <mesh_term>Fluorouracil</mesh_term>
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
  </intervention_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/NCT03828227
org study id: COLAGE C18-01 PRODIGE 66
nct id: NCT03828227
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A national, multicenter, open-label, randomized phase III study. The trial aim is to
      determine the best therapeutic strategies according with the HRQoL.
Treatment cohort will be determined based on three parameters:

        -  Serum albumin level at baseline,

        -  ECOG Performance Status,

        -  Mini GDS.

      The "Candidate" group will be defined according to (all the following criteria must be
      fulfilled):

        -  Serum albumin level ≥ 30g/L,

        -  ECOG PS 0-1 (whatever mini GDS score) or ECOG PS 2 with mini GDS 0 (ie, no depression).

      The "Non-candidate" cohort group will be defined according to (at least one of those
      parameters is fulfilled):

        -  Serum albumin level < 30g/L.

        -  And/ or ECOG PS 2 and mini GDS ≥ 1 (ie, depression).

      Patients in the "Candidate group" will be randomized to:

        -  OPTIMOX bevacizumab (arm A),

        -  Capecitabine + bevacizumab (arm B), in priority followed by FOLFOX-bevacizumab at first
           progression.

      Patients in the "Non-candidate" group cohort

      - Not randomized, follow-up patients receiving: capecitabine + bevacizumab
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Health-related quality of life (HRQoL) at 6 months in the "candidate group".
time frame: At 6 months
description: Improvement of HRQoL at 6 months by 10 points compared to the score at inclusion on the following targeted dimensions: emotional functioning (4 items) and global health (2 items) (score from 6-30 with higher values representing better quality of life).
measure: Number of patients amenable to second-line therapy.
time frame: until 58 months
description: Proportion of patients amenable to second-line therapy.
measure: Number of patient amenable to surgery and/or locoregional therapy.
time frame: until 58 months
description: Proportion of patients amenable to salvage surgery and/or locoregional therapy (e.g., radiofrequency ablation, stereotactic radiotherapy, …).
measure: Progression-free survival (PFS)
time frame: until 58 months
description: PFS is defined as time from date of first dose of study treatment to date of first documented PD or death due to any cause determined by the Investigator assessment in accordance to RECIST 1.1. Alive patients without progression will be censored at the last tumor assessment, either during study treatment period or during follow-up period.
measure: Overall survival (OS)
time frame: Until 58 months
description: OS defined as the time between the date of the first dose of study treatment and the death date. Alive patients will be censored at the last date known to be alive, either during study treatment period or during follow-up period.
measure: Other dimensions of health-related quality of life (HRQoL) and longitudinal HRQoL
time frame: Until 58 months
description: HRQoL: all other dimensions of the QLQC-30 and QLQELD-14 questionnaires, and longitudinal analyses of the QLQC-30 and QLQELD-14 elderly specific module integrating all measurement times.
measure: Determination of instrumental activities of daily living (IADL) as prognostic factor for overall survival (OS).
time frame: Until 58 months
description: IADL as prognostic factor for overall survival (OS) and treatment toxicity.
measure: G8 score at baseline.
time frame: until 58 months
description: To determine G8 score at baseline and to correlate the candidate group and the non-candidate group according to G8 score.
measure: Performance status geriatric (PSG) score.
time frame: until 58 months
description: External analysis of PSG score as predictive for treatment efficacy: PFS and OS.
arm group label: "Candidate group" OPTIMOX plus bevacizumab (Arm A)
arm group type: Active Comparator
description: Patients with :
Serum albumin level ≥ 30g/L,
ECOG PS 0-1 (whatever mini GDS score) or ECOG PS 2 with mini GDS 0 (ie, no depression).
Adapted FOLFOX7 (aFOLFOX7)-bevacizumab for 6 cycles and then Adapted LV5FU2 (aLV5FU2)-bevacizumab (until progression or or unacceptable limiting toxicity)
arm group label: "Candidate group" - Capecitabine-bevacizumab (Arm B)
arm group type: Active Comparator
description: Patients with :
Serum albumin level ≥ 30g/L,
ECOG PS 0-1 (whatever mini GDS score) or ECOG PS 2 with mini GDS 0 (ie, no depression).
This treatment regimen will be given until disease progression (PD) or unacceptable limiting toxicity, as follows:
arm group label: "Non candidate group" - Capecitabine-bevacizumab
arm group type: Active Comparator
description: Patients with:
Serum albumin level < 30g/L.
And/ or ECOG PS 2 and mini GDS ≥ 1 (ie, depression).
This treatment regimen will be given until disease progression (PD) or unacceptable limiting toxicity, as follows:
intervention type: Drug
intervention name: OPTIMOX-bevacizumab
description: Induction Adapted FOLFOX7 (aFOLFOX7)-bevacizumab for 6 cycles (3 months)
Bevacizumab: 5 mg/kg IV (day 1, every 2 weeks [q2w]),
Folinic acid (FA): 400 mg/m² IV/2h (day 1, q2w),
Oxaliplatin: 85 mg/m² IV/2h (day 1, q2w),
5-fluorouracil (5-FU) continuous infusion 2400 mg/m² IV/46h (day 1-2, q2w),
No 5-FU bolus.
then Maintenance Adapted LV5FU2 (aLV5FU2)-bevacizumab (until progression or or unacceptable limiting toxicity)
Bevacizumab: 5 mg/kg IV (day 1, q2w),
FA: 400 mg/m² IV/2h (day 1, q2w),
5-FU continuous infusion 2400 mg/m² IV/46h (day 1-2, q2w)
No 5-FU bolus
arm group label: "Candidate group" OPTIMOX plus bevacizumab (Arm A)
other name: Folinic acid (FA)-5-fluorouracil (5-FU)-oxaliplatin [OPTIMOX]
other name: Avastin
intervention type: Drug
intervention name: Capecitabine plus bevacizumab
description: Bevacizumab: 7.5 mg/kg intravenous infusion [IV] (day 1; q3w),
Capecitabine: 1000 mg/m² orally twice a day (day 1 through day 14, q3w).
arm group label: "Candidate group" - Capecitabine-bevacizumab (Arm B)
arm group label: "Non candidate group" - Capecitabine-bevacizumab
other name: capecitabine
other name: Avastin
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
last name: Elisabeth CAROLA, MD
role: Principal Investigator
affiliation: UCOG Picardie Groupe Hospitalier Public du Sud de l'Oise (GHPSO)
last name: Elisabeth CAROLA, MD
phone: 0140298500
email: Elisabeth.Carola@ghpso.fr
last name: Marie-Line GARCIA LARNICOL, MD
phone: 0140298500
email: marie-line.garcia-larnicol@gercor.com.fr
facility: 
status: Not yet recruiting
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investigator: 
country: France
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Bevacizumab
mesh term: Fluorouracil
mesh term: Capecitabine
mesh term: Oxaliplatin
sharing ipd: No