<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/NCT03006432</url>
  </required_header>
  <id_info>
    <org_study_id>PRODIGE 51</org_study_id>
    <nct_id>NCT03006432</nct_id>
  </id_info>
  <brief_title>PHASE III RANDOMISED TRIAL TO EVALUATE FOLFOX WITH OR WITHOUT DOCETAXEL (TFOX) AS 1st LINE CHEMOTHERAPY FOR LOCALLY ADVANCED OR METASTATIC OESOPHAGO-GASTRIC CARCINOMA</brief_title>
  <acronym>GASTFOX</acronym>
  <official_title>ESSAI DE PHASE III RANDOMISE EVALUANT LE FOLFOX AVEC OU SANS DOCETAXEL (TFOX) EN 1ère LIGNE DE CHIMIOTHERAPIE DES ADENOCARCINOMES OESO-GASTRIQUES LOCALEMENT AVANCES OU METASTATIQUES</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federation Francophone de Cancerologie Digestive</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UNICANCER</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>GERCOR - Multidisciplinary Oncology Cooperative Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federation Francophone de Cancerologie Digestive</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gastric cancer is the fourth commonest cancer and the second largest cause of mortality from&#xD;
      cancer. Surgical resection of localised forms of gastric cancer offers the only chance of a&#xD;
      cure. The vast majority of patients, however, present with advanced disease from the outset&#xD;
      (locally advanced or metastatic) or recurrent after resection of a localised form.&#xD;
&#xD;
      For metastatic or locally advanced stages of gastric or gastro-oesophageal junction&#xD;
      adenocarcinoma, the combination of 2 chemotherapy drugs (dual therapy) as compared with&#xD;
      monotherapy or no chemotherapy, makes it possible to improve the tumour response and patient&#xD;
      survival. Dual therapy comprising cisplatin + fluoropyrimidine (CF protocol) is considered as&#xD;
      one of the first-line chemotherapy treatment standards.&#xD;
&#xD;
      The addition of docetaxel to the CF regime (referred to as the DCF protocol) has made it&#xD;
      possible to improve the tumour response rate, the time to tumour progression and overall&#xD;
      survival in a randomised phase III trial. This improvement in treatment efficacy was&#xD;
      achieved, however, at the expense of a significant increase in grade 3-4 toxicity, including&#xD;
      diarrhoea , neutropenia, and neutropenia with complications. Although DCF is considered as a&#xD;
      therapeutic standard for advanced forms of gastric cancer, its use is limited in clinical&#xD;
      practice due to its high toxicity.&#xD;
&#xD;
      Oxaliplatin has shown its usefulness in treatment of oesophagogastric cancer, with an&#xD;
      efficacy at least equal to that of cisplatin. Peripheral sensory neuropathy was less common&#xD;
      in the 5FU-cisplatin arm. In terms of treatment efficacy, 5FU-oxaliplatin versus&#xD;
      5FU-cisplatin was associated with a non-significant improvement in median progression free&#xD;
      survival rates, and overall survival.&#xD;
&#xD;
      All these data thus suggest that 5FU-oxaliplatin is at least as efficacious and is better&#xD;
      tolerated than 5FU-cisplatin, and also that docetaxel-5FU-cisplatin is more efficacious than&#xD;
      5FU-cisplatin, with limited use due to its high toxicity. In the logical continuation of&#xD;
      development of chemotherapy protocols for metastatic gastric cancer, the question therefore&#xD;
      arises of the usefulness of adding docetaxel to 5FU-oxaliplatin, in terms of efficacy and&#xD;
      also tolerance.&#xD;
&#xD;
      In France, chemotherapy with FOLFOX is used extensively as a first line of treatment in&#xD;
      advanced gastric cancer, but with progression-free survival and median survival rates that&#xD;
      are still too low, and a poor response rate. The use of docetaxel at a dose of 50 mg/m2 every&#xD;
      2 weeks in combination with FOLFOX (TFOX protocol) has shown very interesting results in&#xD;
      phase II studies in terms of efficacy and tolerability, and these are worth confirming&#xD;
      through a phase III randomised trial. In fact, if these results are confirmed in phase III,&#xD;
      TFOX could become the new first-line therapeutic standard for advanced gastric cancer, while&#xD;
      limiting toxicity and preserving patients' quality of life, and could become the reference&#xD;
      treatment to accompany the targeted therapies currently being developed for this disease.&#xD;
&#xD;
      The primary objective of this randomised phase III trial is to compare the progression-free&#xD;
      survival on dual therapy with 5FU-oxaliplatin (FOLFOX protocol) with triple therapy with&#xD;
      5FU-oxaliplatin-docetaxel (TFOX protocol) in treatment of advanced forms of gastric or&#xD;
      oesophagogastric junction adenocarcinoma. The secondary objectives are overall survival, the&#xD;
      tumour response rate, toxicity, quality of life and the therapeutic index, defined as the&#xD;
      ratio between the median progression-free survival and the febrile neutropenia rate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 19, 2016</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Actual">April 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>progression-free survival</measure>
    <time_frame>12 months after laste randomisation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival Toxicity events (adverse events) according to NCI-CTC v4.0</measure>
    <time_frame>12 months after laste randomisation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate</measure>
    <time_frame>12 months after laste randomisation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Toxicity events according to NCI-CTC v4.0</measure>
    <time_frame>12 months after laste randomisation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">507</enrollment>
  <condition>OESOPHAGO-GASTRIC CARCINOMA</condition>
  <arm_group>
    <arm_group_label>FOLFOX</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cycles every 15 days until progression desease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TFOX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cycles every 15 days until progression desease</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <arm_group_label>FOLFOX</arm_group_label>
    <arm_group_label>TFOX</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5Fluorouracil bolus</intervention_name>
    <arm_group_label>FOLFOX</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5Fluorouracil continu</intervention_name>
    <arm_group_label>FOLFOX</arm_group_label>
    <arm_group_label>TFOX</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <arm_group_label>TFOX</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Folinic Acid</intervention_name>
    <arm_group_label>FOLFOX</arm_group_label>
    <arm_group_label>TFOX</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gastric or gastro-oesophageal junction adenocarcinoma (all Siewert), histologically&#xD;
             proven (on primary tumour or metastatic lesion),&#xD;
&#xD;
          -  HER2 negative (positive HER2 status is defined by a positive IHC test of 3+ or IHC of&#xD;
             2+ with positive FISH)&#xD;
&#xD;
          -  Metastatic or non-resectable (locally advanced) disease&#xD;
&#xD;
          -  Disease measurable according to RECIST v1.1 criteria (at least one measurable lesion)&#xD;
&#xD;
          -  No major surgical procedure during the 4 weeks prior to randomisation:&#xD;
&#xD;
          -  Patient eligible for a 1st line of chemotherapy based on 5FU, folinic acid and&#xD;
             oxaliplatin (FOLFOX) with or without docetaxel (TFOX)&#xD;
&#xD;
          -  WHO: 0-1&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
          -  BMI &gt; 18&#xD;
&#xD;
          -  Life expectancy &gt; 3 months&#xD;
&#xD;
          -  PNN &gt; 1500/mm3, platelets &gt; 100,000/mm3, Hb &gt; 10 g/dL&#xD;
&#xD;
          -  AST, ALT ≤ 3.5 times the UNL, alkaline phosphatase &lt; 6 times the UNL&#xD;
&#xD;
          -  Bilirubin ≤ 1.5 times the UNL,&#xD;
&#xD;
          -  Creatinine clearance according to Cockcroft and Gault formula &gt; 50 mL/min&#xD;
&#xD;
          -  Women of childbearing age must have a negative pregnancy test (β HCG) before starting&#xD;
             treatment&#xD;
&#xD;
          -  Women of childbearing age and men (who are in a sexual relationship with women of&#xD;
             childbearing age) must agree to use effective contraception without interruption for&#xD;
             the duration of the treatment and for 6 months after administration of the last dose&#xD;
             of treatment&#xD;
&#xD;
          -  Patient affiliated to a social security scheme&#xD;
&#xD;
          -  Patient information and signature of informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of cerebral or meningeal metastases&#xD;
&#xD;
          -  Presence of &gt; grade 2 neuropathy according to NCIC-CTC 4.0&#xD;
&#xD;
          -  Known DPD deficiency&#xD;
&#xD;
          -  QT/QTc interval &gt; 450 msec for men and &gt; 470 msec for women&#xD;
&#xD;
          -  K+ &lt; LNL, Mg2+ &lt; LNL, Ca2+ &lt; LNL&#xD;
&#xD;
          -  Any known specific contraindication or allergy to the treatments used in the study (cf&#xD;
             RCP Appendix 7)&#xD;
&#xD;
          -  Chemotherapy or radio-chemotherapy in an adjuvant situation finished less than 12&#xD;
             months ago&#xD;
&#xD;
          -  Prior chemotherapy including oxaliplatin (except for adjuvant chemotherapy)&#xD;
&#xD;
          -  Prior chemotherapy including docetaxel&#xD;
&#xD;
          -  Any progressive pathology not stabilised over the past 6 months: liver impairment,&#xD;
             renal impairment, respiratory or cardiac failure&#xD;
&#xD;
          -  HIV+ patients&#xD;
&#xD;
          -  Radiotherapy during the 4 weeks prior to randomisation&#xD;
&#xD;
          -  Other concomitant cancer or a history of cancer during the previous 5 years, with the&#xD;
             exception of carcinoma in situ of the cervix or basal cell carcinoma or epidermoid&#xD;
             cell carcinoma of the skin which is considered to be cured&#xD;
&#xD;
          -  Patient already included in another clinical trial involving an experimental drug&#xD;
&#xD;
          -  Pregnant or breastfeeding woman&#xD;
&#xD;
          -  Persons in custody or under wardship&#xD;
&#xD;
          -  Impossibility of undergoing medical monitoring during the trial for geographical,&#xD;
             social or psychological reasons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aziz ZAANAN</last_name>
    <role>Study Chair</role>
    <affiliation>HEGP, Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HEGP</name>
      <address>
        <city>Paris</city>
        <state>Ile De France</state>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH d'Abbeville</name>
      <address>
        <city>Abbeville CEDEX</city>
        <zip>80142</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Amiens-Picardie</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU d'Angers</name>
      <address>
        <city>Angers CEDEX 9</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Privé D'Antony</name>
      <address>
        <city>Antony</city>
        <zip>92166</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH d'Auxerre</name>
      <address>
        <city>Auxerre</city>
        <zip>89000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de la Côte Basque</name>
      <address>
        <city>Bayonne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH</name>
      <address>
        <city>Beauvais</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Germont et Gauthier</name>
      <address>
        <city>Bethune CEDEX</city>
        <zip>62408</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de Radiothérapie Pierre Curie</name>
      <address>
        <city>Beuvry</city>
        <zip>62660</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Blois</name>
      <address>
        <city>Blois</city>
        <zip>41000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Bergonie</name>
      <address>
        <city>Bordeaux CEDEX</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinique de Bordeaux Nord</name>
      <address>
        <city>Bordeaux CEDEX</city>
        <zip>33077</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Tivoli</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinique Saint Privat</name>
      <address>
        <city>Boujan-sur-Libron</city>
        <zip>34760</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Duchenne</name>
      <address>
        <city>Boulogne Sur Mer</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CMCO Côte d'Opale</name>
      <address>
        <city>Boulogne-sur-Mer</city>
        <zip>62222</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Pierre Oudot</name>
      <address>
        <city>Bourgoin-Jallieu</city>
        <zip>38300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Côte de Nacre</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Infirmerie Protestante de Lyon</name>
      <address>
        <city>Caluire-et-Cuire</city>
        <zip>69300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Médipôle de Savoie</name>
      <address>
        <city>Challes-les-Eaux</city>
        <zip>73190</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH William Morey</name>
      <address>
        <city>Chalon-sur-Saône</city>
        <zip>71100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Metropole Savoie</name>
      <address>
        <city>Chambery</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Général</name>
      <address>
        <city>Châlons-en-Champagne</city>
        <zip>51005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopitaux civils de Colmar</name>
      <address>
        <city>Colmar</city>
        <zip>68024</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Saint Côme</name>
      <address>
        <city>Compiègne CEDEX</city>
        <zip>60204</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Sud Francilien</name>
      <address>
        <city>Corbeil Essonnes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique des Cèdres</name>
      <address>
        <city>Cornebarrieu</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI</name>
      <address>
        <city>Creteil</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Henri Mondor</name>
      <address>
        <city>Créteil CEDEX</city>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie de Bourgogne - GRRECC</name>
      <address>
        <city>Dijon</city>
        <zip>2100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Georges-François Leclerc</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI Elbeuf-Louvier-Val de Reuil</name>
      <address>
        <city>Elbeuf</city>
        <zip>76503</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Jacques Monod</name>
      <address>
        <city>Flers CEDEX</city>
        <zip>61104</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI de Fréjus Saint-Raphaël</name>
      <address>
        <city>Fréjus</city>
        <zip>83600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GHM Institut Daniel Hollard</name>
      <address>
        <city>Grenoble CEDEX 1</city>
        <zip>38028</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital privé Toulon/Hyères</name>
      <address>
        <city>Hyeres</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHD Vendée</name>
      <address>
        <city>La Roche-sur-Yon</city>
        <zip>85925</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Grenoble - Hôpital Albert Michallon</name>
      <address>
        <city>La Tronche</city>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Hospitalier Franco-Britannique</name>
      <address>
        <city>Levallois Perret</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique François Chénieux</name>
      <address>
        <city>Limoges</city>
        <zip>87000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Dupuytren</name>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Longjumeau</name>
      <address>
        <city>Longjumeau</city>
        <zip>91160</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique de la Sauvegarde</name>
      <address>
        <city>Lyon CEDEX 09</city>
        <zip>69009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Lyon - Croix Rousse</name>
      <address>
        <city>Lyon</city>
        <zip>69317</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Saint Joseph - Saint Luc</name>
      <address>
        <city>Lyon</city>
        <zip>69365</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Léon Berard</name>
      <address>
        <city>Lyon</city>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Edouard Herriot</name>
      <address>
        <city>Lyon</city>
        <zip>69437</zip>
        <country>France</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Hôpital Privé Jean Mermoz</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Nord</name>
      <address>
        <city>Marseille CEDEX 20</city>
        <zip>13915</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU La Timone</name>
      <address>
        <city>Marseille CEDEX 5</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Européen</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
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    </facility>
  </location>
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    <facility>
      <name>CH</name>
      <address>
        <city>Meaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Monod</name>
      <address>
        <city>Montivilliers</city>
        <zip>76290</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Régional du Cancer Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier</name>
      <address>
        <city>Montélimar</city>
        <zip>26216</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital privé du Confluent SAS</name>
      <address>
        <city>Nantes</city>
        <zip>44277</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Pierre Bérégovoy</name>
      <address>
        <city>Nevers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Niort</name>
      <address>
        <city>Niort</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de la source</name>
      <address>
        <city>Orléans CEDEX 2</city>
        <zip>45067</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Régional de la Source</name>
      <address>
        <city>Orléans</city>
        <zip>45067</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Tenon</name>
      <address>
        <city>Paris CEDEX 20</city>
        <zip>75970</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Cochin</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Croix Saint Simon</name>
      <address>
        <city>Paris</city>
        <zip>75020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Antoine</name>
      <address>
        <city>Paris</city>
        <zip>75571</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Paris Saint Joseph</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Pitié Salpêtrière</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Louis</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Mutualiste Montsouris</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier</name>
      <address>
        <city>Pau CEDEX</city>
        <zip>64046</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinique Francheville</name>
      <address>
        <city>Perigueux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Saint Jean</name>
      <address>
        <city>Perpignan</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Haut Leveque</name>
      <address>
        <city>Pessac CEDEX</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Lyon Sud</name>
      <address>
        <city>Pierre-Bénite CEDEX</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Milétrie</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Annecy Genevois</name>
      <address>
        <city>Pringy</city>
        <zip>74374</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Robert Debré</name>
      <address>
        <city>Reims CEDEX</city>
        <zip>51092</zip>
        <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>CHU Charles Nicolle</name>
      <address>
        <city>Rouen CEDEX 01</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinique Côte Basque</name>
      <address>
        <city>Saint Jean de Luz</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Lucien Neuwirth</name>
      <address>
        <city>Saint Priest En Jarez</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Plyclinique Saint Claude</name>
      <address>
        <city>Saint Quentin</city>
        <zip>02100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Saint Malo</name>
      <address>
        <city>Saint-Malo</city>
        <zip>35403</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Joliot Curie</name>
      <address>
        <city>Saint-Martin-Boulogne</city>
        <zip>62280</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Saint Etienne - Hôpital Nord</name>
      <address>
        <city>Saint-Priest-en-Jarez</city>
        <zip>42270</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Trenel</name>
      <address>
        <city>Sainte Colombe</city>
        <zip>69560</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de cancérologie</name>
      <address>
        <city>Sarcelles</city>
        <zip>95200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH</name>
      <address>
        <city>Senlis CEDEX</city>
        <zip>60309</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Sainte Anne</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux du Leman</name>
      <address>
        <city>Thonon-les-Bains</city>
        <zip>74203</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Pasteur</name>
      <address>
        <city>Toulouse</city>
        <zip>31300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Trousseau</name>
      <address>
        <city>Tours CEDEX 9</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Troyes</name>
      <address>
        <city>Troyes CEDEX</city>
        <zip>10003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>entre Hospitalier</name>
      <address>
        <city>Valenciennes</city>
        <zip>59322</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nancy-Brabois</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Privé de Villeneuve d'Asq</name>
      <address>
        <city>Villeneuve-d'Ascq</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Fort de France</name>
      <address>
        <city>Fort-de-France</city>
        <zip>97261</zip>
        <country>Martinique</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Martinique</country>
  </location_countries>
  <reference>
    <citation>Zaanan A, Samalin E, Aparicio T, Bouche O, Laurent-Puig P, Manfredi S, Michel P, Monterymard C, Moreau M, Rougier P, Tougeron D, Taieb J, Louvet C. Phase III randomized trial comparing 5-fluorouracil and oxaliplatin with or without docetaxel in first-line advanced gastric cancer chemotherapy (GASTFOX study). Dig Liver Dis. 2018 Apr;50(4):408-410. doi: 10.1016/j.dld.2018.01.119. Epub 2018 Mar 1.</citation>
    <PMID>29409778</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>July 11, 2023</last_update_submitted>
  <last_update_submitted_qc>July 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>OESOPHAGO-GASTRIC CARCINOMA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Stomach 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>Docetaxel</mesh_term>
    <mesh_term>Fluorouracil</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Levoleucovorin</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/NCT03006432
org study id: PRODIGE 51
nct id: NCT03006432
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Gastric cancer is the fourth commonest cancer and the second largest cause of mortality from
      cancer. Surgical resection of localised forms of gastric cancer offers the only chance of a
      cure. The vast majority of patients, however, present with advanced disease from the outset
      (locally advanced or metastatic) or recurrent after resection of a localised form.

      For metastatic or locally advanced stages of gastric or gastro-oesophageal junction
      adenocarcinoma, the combination of 2 chemotherapy drugs (dual therapy) as compared with
      monotherapy or no chemotherapy, makes it possible to improve the tumour response and patient
      survival. Dual therapy comprising cisplatin + fluoropyrimidine (CF protocol) is considered as
      one of the first-line chemotherapy treatment standards.

      The addition of docetaxel to the CF regime (referred to as the DCF protocol) has made it
      possible to improve the tumour response rate, the time to tumour progression and overall
      survival in a randomised phase III trial. This improvement in treatment efficacy was
      achieved, however, at the expense of a significant increase in grade 3-4 toxicity, including
      diarrhoea , neutropenia, and neutropenia with complications. Although DCF is considered as a
      therapeutic standard for advanced forms of gastric cancer, its use is limited in clinical
      practice due to its high toxicity.

      Oxaliplatin has shown its usefulness in treatment of oesophagogastric cancer, with an
      efficacy at least equal to that of cisplatin. Peripheral sensory neuropathy was less common
      in the 5FU-cisplatin arm. In terms of treatment efficacy, 5FU-oxaliplatin versus
      5FU-cisplatin was associated with a non-significant improvement in median progression free
      survival rates, and overall survival.

      All these data thus suggest that 5FU-oxaliplatin is at least as efficacious and is better
      tolerated than 5FU-cisplatin, and also that docetaxel-5FU-cisplatin is more efficacious than
      5FU-cisplatin, with limited use due to its high toxicity. In the logical continuation of
      development of chemotherapy protocols for metastatic gastric cancer, the question therefore
      arises of the usefulness of adding docetaxel to 5FU-oxaliplatin, in terms of efficacy and
      also tolerance.

      In France, chemotherapy with FOLFOX is used extensively as a first line of treatment in
      advanced gastric cancer, but with progression-free survival and median survival rates that
      are still too low, and a poor response rate. The use of docetaxel at a dose of 50 mg/m2 every
      2 weeks in combination with FOLFOX (TFOX protocol) has shown very interesting results in
      phase II studies in terms of efficacy and tolerability, and these are worth confirming
      through a phase III randomised trial. In fact, if these results are confirmed in phase III,
      TFOX could become the new first-line therapeutic standard for advanced gastric cancer, while
      limiting toxicity and preserving patients' quality of life, and could become the reference
      treatment to accompany the targeted therapies currently being developed for this disease.

      The primary objective of this randomised phase III trial is to compare the progression-free
      survival on dual therapy with 5FU-oxaliplatin (FOLFOX protocol) with triple therapy with
      5FU-oxaliplatin-docetaxel (TFOX protocol) in treatment of advanced forms of gastric or
      oesophagogastric junction adenocarcinoma. The secondary objectives are overall survival, the
      tumour response rate, toxicity, quality of life and the therapeutic index, defined as the
      ratio between the median progression-free survival and the febrile neutropenia rate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: progression-free survival
time frame: 12 months after laste randomisation
measure: Overall survival Toxicity events (adverse events) according to NCI-CTC v4.0
time frame: 12 months after laste randomisation
measure: Objective response rate
time frame: 12 months after laste randomisation
measure: Toxicity events according to NCI-CTC v4.0
time frame: 12 months after laste randomisation
arm group label: FOLFOX
arm group type: Active Comparator
description: Cycles every 15 days until progression desease
arm group label: TFOX
arm group type: Experimental
description: Cycles every 15 days until progression desease
intervention type: Drug
intervention name: Oxaliplatin
arm group label: FOLFOX
arm group label: TFOX
intervention type: Drug
intervention name: 5Fluorouracil bolus
arm group label: FOLFOX
intervention type: Drug
intervention name: 5Fluorouracil continu
arm group label: FOLFOX
arm group label: TFOX
intervention type: Drug
intervention name: Docetaxel
arm group label: TFOX
intervention type: Drug
intervention name: Folinic Acid
arm group label: FOLFOX
arm group label: TFOX
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aziz ZAANAN
role: Study Chair
affiliation: HEGP, Paris
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country: France
country: Martinique
citation: Zaanan A, Samalin E, Aparicio T, Bouche O, Laurent-Puig P, Manfredi S, Michel P, Monterymard C, Moreau M, Rougier P, Tougeron D, Taieb J, Louvet C. Phase III randomized trial comparing 5-fluorouracil and oxaliplatin with or without docetaxel in first-line advanced gastric cancer chemotherapy (GASTFOX study). Dig Liver Dis. 2018 Apr;50(4):408-410. doi: 10.1016/j.dld.2018.01.119. Epub 2018 Mar 1.
PMID: 29409778
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Stomach Neoplasms
mesh term: Leucovorin
mesh term: Folic Acid
mesh term: Docetaxel
mesh term: Fluorouracil
mesh term: Oxaliplatin
mesh term: Levoleucovorin
sharing ipd: No