<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/NCT03760822</url>
  </required_header>
  <id_info>
    <org_study_id>PRODIGE 55 - SOCRATE</org_study_id>
    <nct_id>NCT03760822</nct_id>
  </id_info>
  <brief_title>Second-Line Chemotherapy With Ramucirumab +/- Paclitaxel in Elderly Advanced Gastric or Gastroesophageal Junction Cancer Patients</brief_title>
  <acronym>SOCRATE</acronym>
  <official_title>Second-Line Chemotherapy With Ramucirumab +/- Paclitaxel in Elderly Advanced Gastric or Gastroesophageal Junction Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federation Francophone de Cancerologie Digestive</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Federation Francophone de Cancerologie Digestive</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is to evaluate six months survival rate and quality of life at 4 months&#xD;
      of ramucirumab alone or in combination with paclitaxel in patients aged 70 years or more who&#xD;
      have stomach or GEJ adenocarcinoma and whose first line of fluoropyrimidine- and&#xD;
      platinumcontaining treatment has failed.&#xD;
&#xD;
      The co-primary endpoints are the following:&#xD;
&#xD;
        -  Six months survival rate&#xD;
&#xD;
        -  Quality of life at 4 months as assessed by the following three target dimensions of the&#xD;
           EORTC QLQ-ELD14 questionnaire: mobility, illness burden and worries about the future&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 16, 2018</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>Phase 2</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>Patient survival rate at 6 months</measure>
    <time_frame>at 6 months</time_frame>
    <description>Rate of patients alive</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life at 4 months as assessed by the following dimension of the EORTC QLQ-ELD14 questionnaire: mobility</measure>
    <time_frame>at 4 months</time_frame>
    <description>Derived from items 31,33 and 34of the ELD14 questionnaire. The score is from 0 to 100. The endpoint is defined as the difference of at least 10 points (clinical significance) between baseline score and 4-months score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life at 4 months as assessed by the following dimension of the EORTC QLQ-ELD14 questionnaire: worries about the future</measure>
    <time_frame>at 4 months</time_frame>
    <description>Derived from items 31,33 and 34of the ELD14 questionnaire. The score is from 0 to 100. The endpoint is defined as the difference of at least 10 points (clinical significance) between baseline score and 4-months score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life at 4 months as assessed by the following dimension of the EORTC QLQ-ELD14 questionnaire: illness burden</measure>
    <time_frame>at 4 months</time_frame>
    <description>Derived from items 43 and 44of the ELD14 questionnaire. The score is from 0 to 100. The endpoint is defined as the difference of at least 10 points (clinical significance) between baseline score and 4-months score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>6 months</time_frame>
    <description>Defined as time to death (whatever cause is) or for patients alive time to last news.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to treatment failure</measure>
    <time_frame>6 months</time_frame>
    <description>Time between randomization and disease progression, treatment interruption or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>6 months</time_frame>
    <description>Progression-free survival (clinical and/or radiological) determined by the investigator based on RECIST V1.1</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">112</enrollment>
  <condition>Stomach Cancer</condition>
  <condition>Stomach Neoplasm</condition>
  <condition>Gastric Cancer</condition>
  <condition>Gastroesophageal Junction Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Ramucirumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IV ramucirumab at 8 mg/kg on D1 and D15</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ramucirumab + Paclitaxel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IV ramucirumab at 8 mg/kg on D1 and D15 IV paclitaxel at 80 mg/m² on D1, D8 and D15</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ramucirumab</intervention_name>
    <description>IV ramucirumab at 8 mg/kg on D1 and D15</description>
    <arm_group_label>Ramucirumab</arm_group_label>
    <arm_group_label>Ramucirumab + Paclitaxel</arm_group_label>
    <other_name>Cyramza</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>IV paclitaxel at 80 mg/m² on D1, D8 and D15</description>
    <arm_group_label>Ramucirumab + Paclitaxel</arm_group_label>
    <other_name>Abraxane</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed, unresectable, locally advanced or metastatic gastric or&#xD;
             gastroesophageal junction (GEJ) adenocarcinoma, whatever HER2 status&#xD;
&#xD;
          -  Aged ≥ 70 years&#xD;
&#xD;
          -  WHO &lt; 2&#xD;
&#xD;
          -  Estimated life expectancy &gt; 3 months&#xD;
&#xD;
          -  Measurable or non-measurable disease according to RECIST 1.1 criteria&#xD;
&#xD;
          -  Documented progression during first-line fluoropyrimidine- and platinum- or irinotecan&#xD;
             containing chemotherapy (with or without anthracycline), or during the 4 months&#xD;
             following the last cycle of such chemotherapy administered for metastatic or locally&#xD;
             advanced disease, or during the 6 months following the last dose of adjuvant therapy&#xD;
             containing fluoropyrimidine and platinium (treatment by immunotherapy is allowed)&#xD;
&#xD;
          -  Adequate hepatic, renal and hematologic function:&#xD;
&#xD;
               -  ANC ≥ 1 500 / mm3, platelets ≥ 100 000 / mm3, hemoglobin ≥ 9 g/dL&#xD;
&#xD;
               -  Blood creatinine ≤ 1.5 x ULN and creatinine clearance (MDRD formula) ≥ 40 mL/min&#xD;
&#xD;
               -  Total bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 3 x ULN (≤ 5 x ULN if hepatic&#xD;
                  metastasis)&#xD;
&#xD;
               -  INR ≤ 1.5 or INR ≤ 3 for patients taking AVK and PTT ≤ 5 seconds above the ULN&#xD;
&#xD;
               -  Dipstick proteinuria ≤ 1+ or 24 hour proteinuria &lt; 1 g in total&#xD;
&#xD;
          -  EORTC QLQ-C30 + QLQ-ELD14, completed and faxed to the Randomization, Management and&#xD;
             Analysis Center of the FFCD&#xD;
&#xD;
          -  IADL geriatric questionnaire, completed and faxed to Randomization Management and&#xD;
             Analysis Center of FFCD&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known cerebral metastasis&#xD;
&#xD;
          -  Prior treatment by taxanes&#xD;
&#xD;
          -  Prior treatment with an antiangiogenic&#xD;
&#xD;
          -  Neuropathy of grade ≥ 2 (NCI-CTCAE 4.0)&#xD;
&#xD;
          -  Unresolved partial or total bowel obstruction, inflammatory bowel disease (such as&#xD;
             Crohn's disease or ulcerative colitis) or extensive gastrointestinal (GI) resection&#xD;
             combined with chronic diarrhea&#xD;
&#xD;
          -  GI perforation and/or fistulae in the 6 months preceding randomization.&#xD;
&#xD;
          -  GI bleeding within the last 3 months of grade ≥ 3 (NCI-CTCAE 4.0)&#xD;
&#xD;
          -  Chronic use of antiplatelet drugs (including aspirin, but a daily intake of ≤ 325&#xD;
             mg/day is accepted), non-steroidal anti-inflammatory drugs (ibuprofen, naproxen),&#xD;
             dipyridamole, clopidogrel or similar agents&#xD;
&#xD;
          -  Any arterial thromboembolic event (such as myocardial infarction, unstable angina,&#xD;
             cerebrovascular accident or transient ischemic attack) in the 6 months preceding&#xD;
             randomization&#xD;
&#xD;
          -  A life-threatening episode of pulmonary embolism in the 6 months preceding&#xD;
             randomization&#xD;
&#xD;
          -  Deep-vein thrombosis, pulmonary embolism (PE), or any other significant&#xD;
             thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis&#xD;
             are not considered &quot;significant&quot; during the 3 months prior to first dose of protocol&#xD;
             therapy&#xD;
&#xD;
          -  Uncompensated congestive heart failure or uncontrolled arrhythmia&#xD;
&#xD;
          -  Uncontrolled hypertension (≥ 140/90 mm Hg for &gt; 4 weeks) despite properly observed&#xD;
             antihypertensive therapy&#xD;
&#xD;
          -  Cirrhosis at a level of Chilg-Pugh B or C; or cirrhosis (any degree) with a history of&#xD;
             hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis.&#xD;
             Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics&#xD;
             or paracentesis&#xD;
&#xD;
          -  Serious or unhealed wound, peptic ulcer or fracture within 28 days of randomization&#xD;
&#xD;
          -  Radiotherapy or major surgery within 28 days of prior to first dose of protocol&#xD;
             therapy, or minor surgery/subcutaneous venous access device placement within 7 days&#xD;
             prior the first dose of protocol therapy&#xD;
&#xD;
          -  Known allergy to paclitaxel or ramucirumab&#xD;
&#xD;
          -  Another concomitant cancer or a history of cancer in the last 5 years, except cervical&#xD;
             carcinoma in situ, cutaneous basal-cell or squamous-cell carcinoma, or any other&#xD;
             carcinoma in situ deemed to be successfully treated&#xD;
&#xD;
          -  Lack of effective contraception in patients (man and/or women) of childbearing age,&#xD;
             and/or their&#xD;
&#xD;
          -  Persons deprived of liberty or under supervision&#xD;
&#xD;
          -  Impossibility of undergoing medical monitoring during the trial for geographic, social&#xD;
             or psychological reasons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Astrid Lièvre, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Pontchaillou - Rennes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CH -</name>
      <address>
        <city>Abbeville</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH - Albi</name>
      <address>
        <city>Albi</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PRIVEE - L'Europe</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAC - ICO Site Paul Papin</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Privee - Hopital Prive</name>
      <address>
        <city>Antony</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch - Victor Dupouy</name>
      <address>
        <city>Argenteuil</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch - Metz Thionville Mercy</name>
      <address>
        <city>Ars-Laquenexy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch - Ght Unyon Auxerre</name>
      <address>
        <city>Auxerre</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Privee - Institut Du Cancer Avignon Provence</name>
      <address>
        <city>Avignon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch - Cote Basque</name>
      <address>
        <city>Bayonne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch - Beauvais Ch</name>
      <address>
        <city>Beauvais</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu - Jean Minjoz</name>
      <address>
        <city>Besançon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Privee - Tivoli</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PRIVEE - Polyclinique Saint Privat</name>
      <address>
        <city>Boujan-sur-Libron</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch - Duchenne</name>
      <address>
        <city>Boulogne-sur-Mer</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch - Pierre Oudot</name>
      <address>
        <city>Bourgoin-Jallieu</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Privee - Pasteur Lanroze</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cac - François Baclesse</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu - Côte de Nacre</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch - Jean Rougier</name>
      <address>
        <city>Cahors</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Privee - Infirmerie Protestante</name>
      <address>
        <city>Caluire-et-Cuire</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH -</name>
      <address>
        <city>Carcassonne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch - Castres Mazamet Chi</name>
      <address>
        <city>Castres</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prive - Médipole de Savoie</name>
      <address>
        <city>Challes-les-Eaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prive - Sainte Marie</name>
      <address>
        <city>Chalon-sur-Saône</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH -</name>
      <address>
        <city>Cholet</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch - Hopitaux Civils de Colmar</name>
      <address>
        <city>Colmar</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopitaux civils de Colmar</name>
      <address>
        <city>Colmar</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu - Louis Mourier</name>
      <address>
        <city>Colombes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prive - Saint Côme</name>
      <address>
        <city>Compiègne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prive - Cédres</name>
      <address>
        <city>Cornebarrieu</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu - Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prive - Centre Leonard de Vinci</name>
      <address>
        <city>Dechy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cac - Gf Leclerc</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu - Francois Mitterrand</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH -</name>
      <address>
        <city>Dunkerque</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI - Elbeuf Louviers Val de Reuil</name>
      <address>
        <city>Elbeuf</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique privée - CENTRE CARIO</name>
      <address>
        <city>Plérin</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 17, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>August 16, 2023</last_update_submitted>
  <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ramucirumab</keyword>
  <keyword>elderly patient</keyword>
  <keyword>second line therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Ramucirumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03760822
org study id: PRODIGE 55 - SOCRATE
nct id: NCT03760822
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The primary objective is to evaluate six months survival rate and quality of life at 4 months
      of ramucirumab alone or in combination with paclitaxel in patients aged 70 years or more who
      have stomach or GEJ adenocarcinoma and whose first line of fluoropyrimidine- and
      platinumcontaining treatment has failed.

      The co-primary endpoints are the following:

        -  Six months survival rate

        -  Quality of life at 4 months as assessed by the following three target dimensions of the
           EORTC QLQ-ELD14 questionnaire: mobility, illness burden and worries about the future
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patient survival rate at 6 months
time frame: at 6 months
description: Rate of patients alive
measure: Quality of life at 4 months as assessed by the following dimension of the EORTC QLQ-ELD14 questionnaire: mobility
time frame: at 4 months
description: Derived from items 31,33 and 34of the ELD14 questionnaire. The score is from 0 to 100. The endpoint is defined as the difference of at least 10 points (clinical significance) between baseline score and 4-months score.
measure: Quality of life at 4 months as assessed by the following dimension of the EORTC QLQ-ELD14 questionnaire: worries about the future
time frame: at 4 months
description: Derived from items 31,33 and 34of the ELD14 questionnaire. The score is from 0 to 100. The endpoint is defined as the difference of at least 10 points (clinical significance) between baseline score and 4-months score.
measure: Quality of life at 4 months as assessed by the following dimension of the EORTC QLQ-ELD14 questionnaire: illness burden
time frame: at 4 months
description: Derived from items 43 and 44of the ELD14 questionnaire. The score is from 0 to 100. The endpoint is defined as the difference of at least 10 points (clinical significance) between baseline score and 4-months score
measure: Overall survival
time frame: 6 months
description: Defined as time to death (whatever cause is) or for patients alive time to last news.
measure: Time to treatment failure
time frame: 6 months
description: Time between randomization and disease progression, treatment interruption or death
measure: Progression-free survival
time frame: 6 months
description: Progression-free survival (clinical and/or radiological) determined by the investigator based on RECIST V1.1
arm group label: Ramucirumab
arm group type: Experimental
description: IV ramucirumab at 8 mg/kg on D1 and D15
arm group label: Ramucirumab + Paclitaxel
arm group type: Active Comparator
description: IV ramucirumab at 8 mg/kg on D1 and D15 IV paclitaxel at 80 mg/m² on D1, D8 and D15
intervention type: Drug
intervention name: Ramucirumab
description: IV ramucirumab at 8 mg/kg on D1 and D15
arm group label: Ramucirumab
arm group label: Ramucirumab + Paclitaxel
other name: Cyramza
intervention type: Drug
intervention name: Paclitaxel
description: IV paclitaxel at 80 mg/m² on D1, D8 and D15
arm group label: Ramucirumab + Paclitaxel
other name: Abraxane
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Astrid Lièvre, Pr
role: Principal Investigator
affiliation: CHU de Pontchaillou - Rennes
facility: 
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country: France
responsible party type: Sponsor
mesh term: Stomach Neoplasms
mesh term: Paclitaxel
mesh term: Ramucirumab
sharing ipd: Undecided