<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/NCT03773367</url>
  </required_header>
  <id_info>
    <org_study_id>SEGCG18-01</org_study_id>
    <nct_id>NCT03773367</nct_id>
  </id_info>
  <brief_title>Irinotecan-based Triplet (FOLFOXIRI) as Perioperative Treatment in Resectable Gastric and Gastroesophageal Junction Adenocarcinoma.</brief_title>
  <acronym>INTENSE</acronym>
  <official_title>Irinotecan-based Triplet (FOLFOXIRI) as Perioperative Treatment in Resectable Gastric and Gastroesophageal Junction Adenocarcinoma.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lund University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lund University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this clinical trial, patients with gastric and gastroesophageal junction adenocarcinoma&#xD;
      will be included. Treatment with curative intent will be given with chemotherapy for 4 cycles&#xD;
      with fluorouracil, oxaliplatin and irinotecan preoperatively followed by surgery, and then&#xD;
      additionally 4 cycles of the same chemotherapy postoperatively. The standard treatment today&#xD;
      is preoperative treatment with fluorouracil and oxaliplatin pre-and postoperatively. The&#xD;
      rationale for this trial is, that the addition of irinotecan might improve treatments&#xD;
      results.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 14, 2018</start_date>
  <completion_date type="Anticipated">January 15, 2026</completion_date>
  <primary_completion_date type="Anticipated">January 15, 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>To determine the rate of histopathological response according to Becker criteria.</measure>
    <time_frame>After surgery.</time_frame>
    <description>Assessment of histopathological response, ypTNM, resection margin and residual tumor status. If Laurén classification and mismatch repair (MMR) or microsatelite instability status (MSI) could not be assessed on pretreatment biopsies it should be assessed on the resected specimen. Results do not have to be awaited before start of chemotherapy.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Resectable Gastric and Gastroesophageal Junction Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Treatment with chemotherapy pre- and postoperative.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluorouracil</intervention_name>
    <description>Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles.</description>
    <arm_group_label>Treatment with chemotherapy pre- and postoperative.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <description>Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles.</description>
    <arm_group_label>Treatment with chemotherapy pre- and postoperative.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Irinotecan</intervention_name>
    <description>Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles.</description>
    <arm_group_label>Treatment with chemotherapy pre- and postoperative.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically verified, resectable gastric or gastroesophageal (GE)&#xD;
             (gastroesophageal) junction (Siewert type I-III) adenocarcinoma Confirmation of&#xD;
             patient operability by surgeon&#xD;
&#xD;
          -  Primary tumor, regional nodes, metastasis (TNM), 8th edition): cT2-4a or cN+, cM0&#xD;
&#xD;
          -  Age: 18 years or older&#xD;
&#xD;
          -  World Health Organization (WHO) performance status ≤ 1&#xD;
&#xD;
          -  Exclusion of peritoneal carcinomatosis (if clinically suspected) via laparoscopy&#xD;
&#xD;
          -  Adequate laboratory findings:&#xD;
&#xD;
               -  hematological: hemoglobin &gt; 90 g/L (transfusion is allowed to attain this),&#xD;
                  absolute neutrophil count (ANC) ≥ 1,5 x 109/L, platelets ≥ 75 x 109/L&#xD;
&#xD;
               -  hepatic: bilirubin ≤ 1.5 x upper limit of normal (ULN), alanine aminotransferase&#xD;
                  (ALAT) ≤ 3 x ULN&#xD;
&#xD;
               -  renal: creatinine ≤ 1.5 x ULN (upper limit of normal)&#xD;
&#xD;
          -  Fertile men and women must use highly effective means of contraception (failure rate&#xD;
             &lt;1%) such as:&#xD;
&#xD;
               -  combined (estrogen and progestogen containing) hormonal contraception associated&#xD;
                  with inhibition of ovulation (oral, intravaginal or transdermal administration)&#xD;
&#xD;
               -  progestogen-only hormonal contraception associated with inhibition of ovulation&#xD;
                  (oral, injectable or implantable administration)&#xD;
&#xD;
               -  intrauterine device&#xD;
&#xD;
               -  intrauterine hormone-releasing system&#xD;
&#xD;
               -  bilateral tubal occlusion&#xD;
&#xD;
               -  vasectomised partner&#xD;
&#xD;
               -  sexual abstinence&#xD;
&#xD;
          -  Signed written informed consent&#xD;
&#xD;
          -  The patient must be able to comply with the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neuroendocrine or adenosquamous carcinoma&#xD;
&#xD;
          -  Prior oncological treatment or surgical resection for the present disease&#xD;
&#xD;
          -  Presence of other concurrent malignancies or previous malignancies within 5 years&#xD;
             except for adequately treated basal or squamous cell carcinoma of the skin or in-situ&#xD;
             carcinoma of the cervix uteri&#xD;
&#xD;
          -  Clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction&#xD;
             (≤ 6 months), unstable angina, New York Heart Association (NYHA) grade III-IV&#xD;
             congestive heart failure&#xD;
&#xD;
          -  Active inflammatory bowel disease&#xD;
&#xD;
          -  Symptomatic peripheral neuropathy greater than grade 1 (CTCAE version 4.03)&#xD;
&#xD;
          -  Known hypersensitivity to any contents of the study drugs&#xD;
&#xD;
          -  Pregnancy (positive pregnancy test) and/or breast feeding&#xD;
&#xD;
          -  Any other serious or uncontrolled illness which in the opinion of the investigator&#xD;
             makes it undesirable for the patient to enter the trial&#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_contact>
    <last_name>David Borg, MD</last_name>
    <phone>+46 46 17 75 20</phone>
    <email>david.borg@skane.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jan Sundberg, RN</last_name>
    <phone>+464617 70 34</phone>
    <email>jan.sundberg@skane.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Oslo University Hospital, Ullevål Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0450</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ghazwan Al-Haidari, MD, PhD</last_name>
      <phone>+47 9969 5782</phone>
      <email>ghazal@ous-hf.no</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lund University Hospital</name>
      <address>
        <city>Lund</city>
        <zip>221 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Borg, MD</last_name>
      <phone>+46 46 17 75 20</phone>
      <email>david.borg@skane.se</email>
    </contact>
    <investigator>
      <last_name>David Borg, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>141 86</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cecilia Radkiewicz, MD, PhD</last_name>
      <phone>+ 46 8 585 836 13</phone>
      <email>cecilia.radkiewicz@sll.se</email>
    </contact>
    <investigator>
      <last_name>Cecilia Radkiewicz, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centrallasarettet i Växjö</name>
      <address>
        <city>Växjö</city>
        <zip>352 34</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ulrika Palenius, MD</last_name>
      <phone>+46 470 58 80 00</phone>
      <email>ulrika.palenius@kronoberg.se</email>
    </contact>
    <investigator>
      <last_name>Ulrika Pallenius, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Norway</country>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>March 11, 2021</last_update_submitted>
  <last_update_submitted_qc>March 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastric adenocarcinoma</keyword>
  <keyword>Gastroesophageal junction adenocarcinoma</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>Fluorouracil</keyword>
  <keyword>Oxaliplatin</keyword>
  <keyword>Irinotecan</keyword>
  <keyword>Preoperative chemotherapy</keyword>
  <keyword>Postoperative chemotherapy</keyword>
  <keyword>Histopathological response</keyword>
  <keyword>Rate of R0-resection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Esophageal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorouracil</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Irinotecan</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/NCT03773367
org study id: SEGCG18-01
nct id: NCT03773367
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this clinical trial, patients with gastric and gastroesophageal junction adenocarcinoma
      will be included. Treatment with curative intent will be given with chemotherapy for 4 cycles
      with fluorouracil, oxaliplatin and irinotecan preoperatively followed by surgery, and then
      additionally 4 cycles of the same chemotherapy postoperatively. The standard treatment today
      is preoperative treatment with fluorouracil and oxaliplatin pre-and postoperatively. The
      rationale for this trial is, that the addition of irinotecan might improve treatments
      results.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To determine the rate of histopathological response according to Becker criteria.
time frame: After surgery.
description: Assessment of histopathological response, ypTNM, resection margin and residual tumor status. If Laurén classification and mismatch repair (MMR) or microsatelite instability status (MSI) could not be assessed on pretreatment biopsies it should be assessed on the resected specimen. Results do not have to be awaited before start of chemotherapy.
arm group label: Treatment with chemotherapy pre- and postoperative.
arm group type: Experimental
intervention type: Drug
intervention name: Fluorouracil
description: Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles.
arm group label: Treatment with chemotherapy pre- and postoperative.
intervention type: Drug
intervention name: Oxaliplatin
description: Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles.
arm group label: Treatment with chemotherapy pre- and postoperative.
intervention type: Drug
intervention name: Irinotecan
description: Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles.
arm group label: Treatment with chemotherapy pre- and postoperative.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Borg, MD
phone: +46 46 17 75 20
email: david.borg@skane.se
last name: Jan Sundberg, RN
phone: +464617 70 34
email: jan.sundberg@skane.se
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Norway
country: Sweden
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Esophageal Neoplasms
mesh term: Fluorouracil
mesh term: Oxaliplatin
mesh term: Irinotecan
sharing ipd: No