<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/NCT01683864</url>
  </required_header>
  <id_info>
    <org_study_id>2011-004405-25</org_study_id>
    <nct_id>NCT01683864</nct_id>
  </id_info>
  <brief_title>Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer</brief_title>
  <acronym>HIPECStomach</acronym>
  <official_title>Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Tuebingen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The gastric carcinoma is one of the four most common tumors occurring worldwide. The advanced&#xD;
      phase is characterized by metastasis and poses a very poor prognosis for survival. In 20%-30%&#xD;
      of gastric carcinomas the tumor spreads into the abdominal cavity, which leads to metastases&#xD;
      in the wall of the peritoneal cavity. This is known as peritoneal carcinomatosis and its&#xD;
      five-year survival rate is less than 2%. Even after R0 resection of a localized gastric&#xD;
      carcinoma the five-year survival rate is only 40%, not least of all because relapses in the&#xD;
      form of peritoneal metastases are a common occurrence.&#xD;
&#xD;
      Patients with gastric carcinoma and not yet diagnosed with metastases, but who show free&#xD;
      tumor cells in cytology in preoperative laparoscopy before neoadjuvant chemotherapy and&#xD;
      gastrectomy, have an 80% risk of developing peritoneal carcinomatosis within one year, which&#xD;
      stands in strong contrast to the 40% risk for patients with negative cytology.&#xD;
&#xD;
      In the study presented here (group A) therapeutic hyperthermic intraperitoneal chemoperfusion&#xD;
      (HIPEC, in the literature also known as HIIC (heated intraoperative intraperitoneal&#xD;
      chemotherapy) or IPHC (intraperitoneal chemohyperthermia)) with mitomycin c and cisplatin&#xD;
      will be administered following gastrectomy in patients with a gastric carcinoma with free&#xD;
      tumor cells in cytology diagnosed in the preoperative laparoscopy in comparison to (group B)&#xD;
      solely gastrectomy in patients with a gastric carcinoma and also with free tumor cells&#xD;
      diagnosed in cytology in the preoperative laparoscopy.&#xD;
&#xD;
      A randomization will be performed between group A and B. Patients with gastric carcinoma (TNM&#xD;
      Stage ≥ T2&lt;T4) without proven metastases (TNM stage M0), with and without involved regional&#xD;
      lymph nodes (TNM stage +N/-N) and positive cytology in preoperative abdominal lavage will be&#xD;
      included. Exclusion criteria are extended disease or inoperable tumor.&#xD;
&#xD;
      This study is already permitted by the local ethic commission and the German Federal&#xD;
      Institute for Drugs and Medical Devices (BfArM) (EudraCT-Nr.: 2011-004405-25 / Study code:&#xD;
      HIPEC_Stomach) and was initiated in August 2012.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment problems&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>Phase 2/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>Peritoneal Carcinosis Free Survival</measure>
    <time_frame>5 Years</time_frame>
    <description>Three patients were enrolled in the study. No study results because no patient has received study drug.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease Free Survival</measure>
    <time_frame>5 years</time_frame>
    <description>No study results because no patient has received study drug.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Procedure Related Complication</measure>
    <time_frame>60 days</time_frame>
    <description>No study results because no patient has received study drug.</description>
  </other_outcome>
  <other_outcome>
    <measure>Kinetics of Mitomycin and Cisplatin</measure>
    <time_frame>24 hours after application</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Gastric Cancer</condition>
  <condition>Peritoneal Carcinomatosis</condition>
  <arm_group>
    <arm_group_label>positive cytology with HIPEC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative</description>
  </arm_group>
  <arm_group>
    <arm_group_label>positive cytology without HIPEC</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>gastric cancer cytology positive without HIPEC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>negative cytology without HIPEC</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>gastric cancer with negative cytology</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>positive cytology with HIPEC</intervention_name>
    <description>HIPEC with mytomycin and cisplatin</description>
    <arm_group_label>positive cytology with HIPEC</arm_group_label>
    <other_name>mytomycin and cisplatin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically proven gastric adenocarcinoma: uT1,uT2, uT3, Nx, M0&#xD;
&#xD;
          2. No prior chemotherapy&#xD;
&#xD;
          3. Patients of full age, independent of gender ECOG ≤ 2&#xD;
&#xD;
          4. No dissemination of the tumor confirmed by CT of the lung and the abdomen.&#xD;
&#xD;
          5. Signed Consent form of the Patient agreeing to investigations&#xD;
&#xD;
          6. Leucocytes &gt; 3.000/µl&#xD;
&#xD;
          7. Thrombocytes &gt; 100.000/µl&#xD;
&#xD;
          8. Creatinine ≤ 1.5mg/dl and or Clearance &gt; 60 ml/min&#xD;
&#xD;
          9. informed consent of the patient&#xD;
&#xD;
         10. normal ejection-fraction of the heart&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Dissemination of the tumor or non-resectable primary tumor&#xD;
&#xD;
          2. Malignant secondary disease &lt; 5 years in the past (Exception: in-situ-carcinoma of the&#xD;
             cervix and appropriately treated basal cell carcinoma of the skin)&#xD;
&#xD;
          3. Patient not of full age&#xD;
&#xD;
          4. Inflammatory chronic bowel disease&#xD;
&#xD;
          5. Inclusion of the patient in a different study&#xD;
&#xD;
          6. Pregnancy or lactation&#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>Alfred Königsrainer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Tuebingen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Tuebingen</name>
      <address>
        <city>Tuebingen</city>
        <state>BW</state>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <results_first_submitted>November 11, 2016</results_first_submitted>
  <results_first_submitted_qc>June 27, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">January 30, 2018</results_first_posted>
  <last_update_submitted>June 27, 2017</last_update_submitted>
  <last_update_submitted_qc>June 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Peritoneal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study was early terminated due to recruitment problem. All active patient have study</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Positive Cytology With HIPEC</title>
          <description>gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative positive cytology with HIPEC: HIPEC with mytomycin and cisplatin</description>
        </group>
        <group group_id="P2">
          <title>Positive Cytology Without HIPEC</title>
          <description>gastric cancer cytology positive without HIPEC</description>
        </group>
        <group group_id="P3">
          <title>Negative Cytology Without HIPEC</title>
          <description>gastric cancer with negative cytology</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>No study results because no patient has received study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Positive Cytology With HIPEC</title>
          <description>gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative positive cytology with HIPEC: HIPEC with mytomycin and cisplatin</description>
        </group>
        <group group_id="B2">
          <title>Positive Cytology no HIPEC</title>
          <description>gastric cancer cytology positive without HIPEC</description>
        </group>
        <group group_id="B3">
          <title>Negative Cytology Without HIPEC</title>
          <description>gastric cancer with negative cytology</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="0"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="0"/>
            <count group_id="B4" value="0"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Peritoneal Carcinosis Free Survival</title>
        <description>Three patients were enrolled in the study. No study results because no patient has received study drug.</description>
        <time_frame>5 Years</time_frame>
        <population>No study results because no patient has received study drug. Patient in the intervention group withdrawal of consent before intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Positive Cytology With HIPEC</title>
            <description>gastric Cancer cytology positive with HIPEC</description>
          </group>
          <group group_id="O2">
            <title>Positive Cytology Witout HIPEC</title>
            <description>gastric cancer positive cytology without HIPC</description>
          </group>
          <group group_id="O3">
            <title>Negative Cytology Without HIPC</title>
            <description>gastric cancer negative cytology without HIPC</description>
          </group>
        </group_list>
        <measure>
          <title>Peritoneal Carcinosis Free Survival</title>
          <description>Three patients were enrolled in the study. No study results because no patient has received study drug.</description>
          <population>No study results because no patient has received study drug. Patient in the intervention group withdrawal of consent before intervention.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Disease Free Survival</title>
        <description>No study results because no patient has received study drug.</description>
        <time_frame>5 years</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Procedure Related Complication</title>
        <description>No study results because no patient has received study drug.</description>
        <time_frame>60 days</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Kinetics of Mitomycin and Cisplatin</title>
        <time_frame>24 hours after application</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Positive Cytology With HIPEC</title>
          <description>gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative positive cytology with HIPEC: HIPEC with mytomycin and cisplatin Adverse Event : NA</description>
        </group>
        <group group_id="E2">
          <title>Positive Cytology no HIPEC</title>
          <description>gastric cancer cytology positive without HIPEC Adverse Event : NA</description>
        </group>
        <group group_id="E3">
          <title>Negative Cytology Without HIPEC</title>
          <description>gastric cancer with negative cytology Adverse Event : NA</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Prof. Alfred Königsrainer</name_or_title>
      <organization>University Clinic of Tübingen</organization>
      <phone>0049 7071 2983290</phone>
      <email>silvia.wagner@med.uni-tuebingen.de</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01683864
org study id: 2011-004405-25
nct id: NCT01683864
lead sponsor: 
has dmc: Yes
Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer
The gastric carcinoma is one of the four most common tumors occurring worldwide. The advanced
      phase is characterized by metastasis and poses a very poor prognosis for survival. In 20%-30%
      of gastric carcinomas the tumor spreads into the abdominal cavity, which leads to metastases
      in the wall of the peritoneal cavity. This is known as peritoneal carcinomatosis and its
      five-year survival rate is less than 2%. Even after R0 resection of a localized gastric
      carcinoma the five-year survival rate is only 40%, not least of all because relapses in the
      form of peritoneal metastases are a common occurrence.

      Patients with gastric carcinoma and not yet diagnosed with metastases, but who show free
      tumor cells in cytology in preoperative laparoscopy before neoadjuvant chemotherapy and
      gastrectomy, have an 80% risk of developing peritoneal carcinomatosis within one year, which
      stands in strong contrast to the 40% risk for patients with negative cytology.

      In the study presented here (group A) therapeutic hyperthermic intraperitoneal chemoperfusion
      (HIPEC, in the literature also known as HIIC (heated intraoperative intraperitoneal
      chemotherapy) or IPHC (intraperitoneal chemohyperthermia)) with mitomycin c and cisplatin
      will be administered following gastrectomy in patients with a gastric carcinoma with free
      tumor cells in cytology diagnosed in the preoperative laparoscopy in comparison to (group B)
      solely gastrectomy in patients with a gastric carcinoma and also with free tumor cells
      diagnosed in cytology in the preoperative laparoscopy.

      A randomization will be performed between group A and B. Patients with gastric carcinoma (TNM
      Stage ≥ T2<T4) without proven metastases (TNM stage M0), with and without involved regional
      lymph nodes (TNM stage +N/-N) and positive cytology in preoperative abdominal lavage will be
      included. Exclusion criteria are extended disease or inoperable tumor.

      This study is already permitted by the local ethic commission and the German Federal
      Institute for Drugs and Medical Devices (BfArM) (EudraCT-Nr.: 2011-004405-25 / Study code:
      HIPEC_Stomach) and was initiated in August 2012.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Peritoneal Carcinosis Free Survival
time frame: 5 Years
description: Three patients were enrolled in the study. No study results because no patient has received study drug.
measure: Disease Free Survival
time frame: 5 years
description: No study results because no patient has received study drug.
measure: Procedure Related Complication
time frame: 60 days
description: No study results because no patient has received study drug.
measure: Kinetics of Mitomycin and Cisplatin
time frame: 24 hours after application
arm group label: positive cytology with HIPEC
arm group type: Experimental
description: gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative
arm group label: positive cytology without HIPEC
arm group type: No Intervention
description: gastric cancer cytology positive without HIPEC
arm group label: negative cytology without HIPEC
arm group type: No Intervention
description: gastric cancer with negative cytology
intervention type: Drug
intervention name: positive cytology with HIPEC
description: HIPEC with mytomycin and cisplatin
arm group label: positive cytology with HIPEC
other name: mytomycin and cisplatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alfred Königsrainer, MD
role: Principal Investigator
affiliation: University Hospital Tuebingen
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Stomach Neoplasms
mesh term: Carcinoma
mesh term: Peritoneal Neoplasms
mesh term: Cisplatin
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 