<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/NCT03001726</url>
  </required_header>
  <id_info>
    <org_study_id>NEO-REGATTA</org_study_id>
    <nct_id>NCT03001726</nct_id>
  </id_info>
  <brief_title>To Observe the Efficacy and Safety by Comparing Chemotherapy(Docetaxel, Oxaliplatin Plus S1 ) Followed With Radical Resection Versus Chemotherapy Alone in Advanced Gastric Cancer With Single Non-curable Factor.</brief_title>
  <official_title>Gastrectomy Plus Chemotherapy Versus Chemotherapy Alone for Advanced Gastric Cancer With a Single Non-curable Factor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators assessed the effectiveness of conversional gastrectomy compared with&#xD;
      chemotherapy alone following docetaxel, oxalipaltin and S1 therapy for advanced gastric&#xD;
      cancer with a single non-curable factor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Palliative chemotherapy is still the standard of care for incurable advanced gastric cancer.&#xD;
      Several retrospective, single institutional studies have shown that the addition of&#xD;
      gastrectomy to chemotherapy might improve patient survival among patients with metastatic&#xD;
      gastric cancer with a single non-curable factor. However, REGATTA trial, a phase 3,&#xD;
      randomized controlled trial, concluded an opposite conclusion that gastrectomy followed by&#xD;
      chemotherapy did not show any survival benefit compared with chemotherapy alone in advanced&#xD;
      gastric cancer with a single non-curable factor. Interestingly, five patients initially&#xD;
      assigned to chemotherapy alone in the study had got survival benefit form gastrectomy with&#xD;
      curative intent because of complete disappear of all non-curable factors during chemotherapy.&#xD;
      This finding raised the question as to conversional radical surgery following upfront&#xD;
      chemotherapy could be a possible treatment option. We assessed the effectiveness of&#xD;
      conversional radical surgery following docetaxel, oxalipaltin and S1 therapy for advanced&#xD;
      gastric cancer with a single non-curable factor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>overall survival</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>progression-free survival</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>response rate</measure>
    <time_frame>through study completion, an average of 24 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>adverse events</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">228</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Gastrectomy plus chemotherapy</arm_group_label>
    <description>In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>chemotherapy alone</arm_group_label>
    <description>Patients received chemotherapy alone.All patients received oral S1 80 mg/m2 per day (80-120 mg/day total dose depending on the patient's body surface area as follows: &lt;1.25 m2, 80 mg; 1.25-1.5 m2, 100 mg; and &gt;1.5 m2, 120 mg) on days 1-21 of every 3-week cycle, oxaliplatin 100 mg/m2 on day 1 of every 3-week cycle and docetaxel 40mg/m2 on day 1 of every 3-weeks cycle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Gastrectomy</intervention_name>
    <description>In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location.</description>
    <arm_group_label>Gastrectomy plus chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oxaliplatin</intervention_name>
    <description>oxaliplatin 100 mg/m2</description>
    <arm_group_label>Gastrectomy plus chemotherapy</arm_group_label>
    <arm_group_label>chemotherapy alone</arm_group_label>
    <other_name>Eloxatin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S1</intervention_name>
    <description>S1 40mg/m2</description>
    <arm_group_label>Gastrectomy plus chemotherapy</arm_group_label>
    <arm_group_label>chemotherapy alone</arm_group_label>
    <other_name>tegafur</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>docetaxel 40 mg/m2</description>
    <arm_group_label>Gastrectomy plus chemotherapy</arm_group_label>
    <arm_group_label>chemotherapy alone</arm_group_label>
    <other_name>Taxotere</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Clinical diagnosis of gastric cancer with a single non-curable factor&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of gastric cancer with a single non-curable factor&#xD;
&#xD;
          -  A single non-curable factor was defined as hepatic metastasis (H1; two to four lesions&#xD;
             of maximum diameter ≤5 cm and minimum diameter ≥1 cm); peritoneal metastasis (P1) in&#xD;
             the diaphragm or peritoneum caudal to the transverse colon without massive ascites or&#xD;
             intestinal obstruction; positive cytology (CY1) when the cancer cells were found in&#xD;
             the peritoneal washing; para-aortic lymph node (PAN) metastasis above the coeliac axis&#xD;
             or below the inferior mesenteric artery (lymph node 16a1/b2 of maximum diameter ≥1&#xD;
             cm), or both; or ovary implant metastasis for one site or two.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who can have radical resection.&#xD;
&#xD;
          -  Patietns who have more than one metastasis.&#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_official>
    <last_name>Tianshu Liu, Physician</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhongshan Hopital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhongshan hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>May 1, 2022</last_update_submitted>
  <last_update_submitted_qc>May 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Zhongshan Hospital</investigator_affiliation>
    <investigator_full_name>Tianshu Liu</investigator_full_name>
    <investigator_title>Chairman for the department of oncology</investigator_title>
  </responsible_party>
  <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>Docetaxel</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Tegafur</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/NCT03001726
org study id: NEO-REGATTA
nct id: NCT03001726
lead sponsor: 
has dmc: Yes
Investigators assessed the effectiveness of conversional gastrectomy compared with
      chemotherapy alone following docetaxel, oxalipaltin and S1 therapy for advanced gastric
      cancer with a single non-curable factor.
Palliative chemotherapy is still the standard of care for incurable advanced gastric cancer.
      Several retrospective, single institutional studies have shown that the addition of
      gastrectomy to chemotherapy might improve patient survival among patients with metastatic
      gastric cancer with a single non-curable factor. However, REGATTA trial, a phase 3,
      randomized controlled trial, concluded an opposite conclusion that gastrectomy followed by
      chemotherapy did not show any survival benefit compared with chemotherapy alone in advanced
      gastric cancer with a single non-curable factor. Interestingly, five patients initially
      assigned to chemotherapy alone in the study had got survival benefit form gastrectomy with
      curative intent because of complete disappear of all non-curable factors during chemotherapy.
      This finding raised the question as to conversional radical surgery following upfront
      chemotherapy could be a possible treatment option. We assessed the effectiveness of
      conversional radical surgery following docetaxel, oxalipaltin and S1 therapy for advanced
      gastric cancer with a single non-curable factor.
observational model: Case-Control
time perspective: Prospective
measure: overall survival
time frame: through study completion, an average of 2 year
measure: progression-free survival
time frame: through study completion, an average of 1 year
measure: response rate
time frame: through study completion, an average of 24 weeks
measure: adverse events
time frame: through study completion, an average of 1 year
arm group label: Gastrectomy plus chemotherapy
description: In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location.
arm group label: chemotherapy alone
description: Patients received chemotherapy alone.All patients received oral S1 80 mg/m2 per day (80-120 mg/day total dose depending on the patient's body surface area as follows: <1.25 m2, 80 mg; 1.25-1.5 m2, 100 mg; and >1.5 m2, 120 mg) on days 1-21 of every 3-week cycle, oxaliplatin 100 mg/m2 on day 1 of every 3-week cycle and docetaxel 40mg/m2 on day 1 of every 3-weeks cycle.
intervention type: Procedure
intervention name: Gastrectomy
description: In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location.
arm group label: Gastrectomy plus chemotherapy
intervention type: Drug
intervention name: oxaliplatin
description: oxaliplatin 100 mg/m2
arm group label: Gastrectomy plus chemotherapy
arm group label: chemotherapy alone
other name: Eloxatin
intervention type: Drug
intervention name: S1
description: S1 40mg/m2
arm group label: Gastrectomy plus chemotherapy
arm group label: chemotherapy alone
other name: tegafur
intervention type: Drug
intervention name: Docetaxel
description: docetaxel 40 mg/m2
arm group label: Gastrectomy plus chemotherapy
arm group label: chemotherapy alone
other name: Taxotere
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Tianshu Liu, Physician
role: Principal Investigator
affiliation: Zhongshan Hopital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Zhongshan Hospital
investigator full name: Tianshu Liu
investigator title: Chairman for the department of oncology
mesh term: Stomach Neoplasms
mesh term: Docetaxel
mesh term: Oxaliplatin
mesh term: Tegafur
sharing ipd: No