<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/NCT03825861</url>
  </required_header>
  <id_info>
    <org_study_id>933/16</org_study_id>
    <nct_id>NCT03825861</nct_id>
  </id_info>
  <brief_title>Neoadjuvant FOLFIRINOX in the Treatment of Locally Advanced Gastric Cancer</brief_title>
  <acronym>FOLFIRINOX</acronym>
  <official_title>Neoadjuvant FOLFIRINOX in the Treatment of Locally Advanced Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto do Cancer do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto do Cancer do Estado de São Paulo</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>
      Phase II single-arm study designed to evaluate the efficacy and safety of preoperative&#xD;
      chemotherapy with FOLFIRINOX regimen. The investigators will include 27 patients with&#xD;
      resectable locally advanced gastric cancer. They will receive preoperative chemotherapy with&#xD;
      FOLFIRINOX regimen by long-term catheter every 14 days for 8 cycles accounting for a total of&#xD;
      4 months of systemic treatment. In the period between 4 and 8 weeks of the last cycle,&#xD;
      restaging tests will be performed and if there is no metastatic progression of disease, the&#xD;
      patient will undergo surgical treatment with curative intention. The objective is to evaluate&#xD;
      whether preoperative treatment with FOLFIRINOX regimen involving continuous infusion and&#xD;
      bolus infusion of 5-fluoruracil, irinotecan bolus and oxaliplatin bolus is effective and safe&#xD;
      in the neoadjuvant treatment of locally advanced gastric cancer.&#xD;
&#xD;
      The planned recruitment period is 48 months (4 years). There will be a total of 4 months of&#xD;
      preoperative chemotherapy. In case of limiting toxicity or disease progression, chemotherapy&#xD;
      will be suspended and patients may undergo resection of the primary neoplasia at the&#xD;
      discretion of the surgical team of the institution. Patients will be followed for 5 years&#xD;
      after entry of the last participant in the protocol for OS and PFS evaluation. The end of the&#xD;
      study will occur when the last participant completes their last follow-up visit, which should&#xD;
      occur no later than 60 months after enrollment in the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 23, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2026</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2026</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pathologic Complete Response (pCR)</measure>
    <time_frame>4-8 weeks after neoadjuvant chemotherapy complete</time_frame>
    <description>To evaluate the Pathologic Complete Response (pCR).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival (DFS)</measure>
    <time_frame>At 2, 3 and 5 years after preoperative treatment with FOLFIRINOX regimen.</time_frame>
    <description>Evaluate Disease-free survival (DFS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>At 2, 3 and 5 years after preoperative treatment with FOLFIRINOX regimen.</time_frame>
    <description>Evaluate Overall survival (OS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>R0-resection rate</measure>
    <time_frame>4-8 weeks after neoadjuvant chemotherapy complete</time_frame>
    <description>Evaluate the R0 resection rate (absence of microscopic residual disease).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Treatment Completion</measure>
    <time_frame>4-8 weeks after neoadjuvant chemotherapy complete</time_frame>
    <description>Evaluate the rate of completion of treatment (chemotherapy and surgical approach).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of adverse events</measure>
    <time_frame>Through neoadjuvant chemotherapy (4 months)</time_frame>
    <description>Rate and description of adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Disease Progression</measure>
    <time_frame>Through neoadjuvant chemotherapy (4 months)</time_frame>
    <description>Evaluate the rate of disease progression.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">27</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>FOLFIRINOX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oxaliplatin 85mg/m2, Leucovorin 200mg/m2, Irinotecan 180mg/m2, 5-FU 400mg/m2 bolus followed by 2400mg/m2 continuous infusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FOLFIRINOX</intervention_name>
    <description>Oxaliplatin 85mg/m2, Leucovorin 200mg/m2, Irinotecan 180mg/m2, 5-FU 400mg/m2 bolus followed by 2400mg/m2 continuous infusion.</description>
    <arm_group_label>FOLFIRINOX</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological diagnosis of gastric adenocarcinoma that is amenable to surgical&#xD;
             resection at diagnosis, with locally advanced disease criteria for clinical evaluation&#xD;
             (T3 tumors, T4 tumors and / or regional lymph node involvement).&#xD;
&#xD;
          -  Absence of metastatic disease at a distance (computerized tomography, diagnostic&#xD;
             laparoscopy and peritoneal lavage).&#xD;
&#xD;
          -  Age 18-75 years.&#xD;
&#xD;
          -  Clinical functionality by the ECOG scale between 0 and 1.&#xD;
&#xD;
          -  Preserved renal function (creatinine clearance greater than 50 mL / min).&#xD;
&#xD;
          -  Signature of Informed Consent Form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active neoplasm of another primary site other than non-melanoma skin carcinoma.&#xD;
&#xD;
          -  Lesions of the esophagogastric transition&#xD;
&#xD;
          -  Unresectable lesions by computed tomography and / or diagnostic laparoscopy.&#xD;
&#xD;
          -  Obstructive tumors (acute intestinal occlusion or subocclusion).&#xD;
&#xD;
          -  Tumors with signs of significant or persistent bleeding.&#xD;
&#xD;
          -  Carcinoma in situ.&#xD;
&#xD;
          -  Different histological type of adenocarcinoma.&#xD;
&#xD;
          -  Gastric stump tumors.&#xD;
&#xD;
          -  Previous chemotherapeutic or radiotherapy treatment.&#xD;
&#xD;
          -  Current pregnancy or breastfeeding.&#xD;
&#xD;
          -  Total bilirubin above 1.5mg / dL.&#xD;
&#xD;
          -  Hepatic transaminases greater than 1.5 times the upper limit of normality.&#xD;
&#xD;
          -  Decompensated and / or symptomatic cardiomyopathy: congestive heart failure with&#xD;
             functional class greater than 2 by the New York Heart Association; active coronary&#xD;
             disease; uncontrolled cardiac arrhythmia; history of acute myocardial infarction in&#xD;
             the last 6 months.&#xD;
&#xD;
          -  Psychological, familial, social or even geographical condition that potentially&#xD;
             hinders adherence to the study protocol and the pre-established follow-up.&#xD;
&#xD;
          -  Current or previous psychiatric or neurological diagnosis that is decompensated,&#xD;
             compromises the cognition, functionality or adherence to the proposed treatment.&#xD;
&#xD;
          -  Other comorbidities that are decompensated at the time of treatment.&#xD;
&#xD;
          -  Pregnant or breastfeeding women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Tiago B. Castria, MD PhD</last_name>
    <phone>+551138934531</phone>
    <email>tiagobiachi@yahoo.com.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>Instituto do Câncer do Estado de São Paulo</name>
      <address>
        <city>São Paulo</city>
        <zip>01246-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tiago Castria, MD PhD</last_name>
      <phone>+5511 3893-2000</phone>
      <email>tiagobiachi@yahoo.com.br</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>November 9, 2020</last_update_submitted>
  <last_update_submitted_qc>November 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastric Cancer</keyword>
  <keyword>FOLFIRINOX</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>Folfirinox</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/NCT03825861
org study id: 933/16
nct id: NCT03825861
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Phase II single-arm study designed to evaluate the efficacy and safety of preoperative
      chemotherapy with FOLFIRINOX regimen. The investigators will include 27 patients with
      resectable locally advanced gastric cancer. They will receive preoperative chemotherapy with
      FOLFIRINOX regimen by long-term catheter every 14 days for 8 cycles accounting for a total of
      4 months of systemic treatment. In the period between 4 and 8 weeks of the last cycle,
      restaging tests will be performed and if there is no metastatic progression of disease, the
      patient will undergo surgical treatment with curative intention. The objective is to evaluate
      whether preoperative treatment with FOLFIRINOX regimen involving continuous infusion and
      bolus infusion of 5-fluoruracil, irinotecan bolus and oxaliplatin bolus is effective and safe
      in the neoadjuvant treatment of locally advanced gastric cancer.

      The planned recruitment period is 48 months (4 years). There will be a total of 4 months of
      preoperative chemotherapy. In case of limiting toxicity or disease progression, chemotherapy
      will be suspended and patients may undergo resection of the primary neoplasia at the
      discretion of the surgical team of the institution. Patients will be followed for 5 years
      after entry of the last participant in the protocol for OS and PFS evaluation. The end of the
      study will occur when the last participant completes their last follow-up visit, which should
      occur no later than 60 months after enrollment in the study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pathologic Complete Response (pCR)
time frame: 4-8 weeks after neoadjuvant chemotherapy complete
description: To evaluate the Pathologic Complete Response (pCR).
measure: Disease-free survival (DFS)
time frame: At 2, 3 and 5 years after preoperative treatment with FOLFIRINOX regimen.
description: Evaluate Disease-free survival (DFS).
measure: Overall survival (OS)
time frame: At 2, 3 and 5 years after preoperative treatment with FOLFIRINOX regimen.
description: Evaluate Overall survival (OS).
measure: R0-resection rate
time frame: 4-8 weeks after neoadjuvant chemotherapy complete
description: Evaluate the R0 resection rate (absence of microscopic residual disease).
measure: Rate of Treatment Completion
time frame: 4-8 weeks after neoadjuvant chemotherapy complete
description: Evaluate the rate of completion of treatment (chemotherapy and surgical approach).
measure: Rate of adverse events
time frame: Through neoadjuvant chemotherapy (4 months)
description: Rate and description of adverse events
measure: Rate of Disease Progression
time frame: Through neoadjuvant chemotherapy (4 months)
description: Evaluate the rate of disease progression.
arm group label: FOLFIRINOX
arm group type: Experimental
description: Oxaliplatin 85mg/m2, Leucovorin 200mg/m2, Irinotecan 180mg/m2, 5-FU 400mg/m2 bolus followed by 2400mg/m2 continuous infusion.
intervention type: Drug
intervention name: FOLFIRINOX
description: Oxaliplatin 85mg/m2, Leucovorin 200mg/m2, Irinotecan 180mg/m2, 5-FU 400mg/m2 bolus followed by 2400mg/m2 continuous infusion.
arm group label: FOLFIRINOX
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Tiago B. Castria, MD PhD
phone: +551138934531
email: tiagobiachi@yahoo.com.br
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Sponsor
mesh term: Stomach Neoplasms
mesh term: Folfirinox
sharing ipd: Undecided