<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/NCT03238404</url>
  </required_header>
  <id_info>
    <org_study_id>BE2015687NAC</org_study_id>
    <nct_id>NCT03238404</nct_id>
  </id_info>
  <brief_title>Neoadjuvant Chemotherapy for Patients With Advanced Gastric Cancer in ERAS Programs for Radical Gastrectomy</brief_title>
  <official_title>The Application of Neoadjuvant Chemotherapy for Patients With Advanced Gastric Cancer in Enhanced Recovery After Surgery Programs for Radical Gastrectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>JIANG Zhi-Wei</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jinling Hospital, China</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>
      Patients with advanced gastric cancer received neoadjuvant chemotherapy undergo enhanced&#xD;
      recovery after surgery (ERAS) programs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In recent years, enhanced recovery after surgery (ERAS) programs were applied in gastrectomy&#xD;
      in areas with a high prevalence of gastric cancer, such as China and Japan, confirming that&#xD;
      ERAS programs accelerate the postoperative rehabilitation of gastric cancer patients without&#xD;
      increasing the occurrence rate of postoperative complications. However, in most studies on&#xD;
      ERAS for gastric cancer, patients who received neoadjuvant chemotherapy were excluded.&#xD;
      Investigators designed this study aimed to evaluate whether patients who receive neoadjuvant&#xD;
      chemotherapy can enrolled into enhanced recovery after surgery programs for locally advanced&#xD;
      gastric cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2015</start_date>
  <completion_date type="Actual">December 20, 2016</completion_date>
  <primary_completion_date type="Actual">August 10, 2016</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>This study is a single-center, parallel, open-label randomized controlled trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative length of stay</measure>
    <time_frame>1 month</time_frame>
    <description>Postoperative length of stay</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>2 months</time_frame>
    <description>Postoperative complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time to first flatus</measure>
    <time_frame>1 week</time_frame>
    <description>Bowel recovery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to semi-liquid diet</measure>
    <time_frame>2 weeks</time_frame>
    <description>Bowel recovery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total protein</measure>
    <time_frame>1 week</time_frame>
    <description>Nutritional status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Albumin</measure>
    <time_frame>1 week</time_frame>
    <description>Nutritional status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prealbumin</measure>
    <time_frame>1 week</time_frame>
    <description>Nutritional status</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>NAC group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive neoadjuvant chemotherapy (NAC) before the gastrectomy and ERAS.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgery alone group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will not receive NAC before the gastrectomy and ERAS.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>NAC group</intervention_name>
    <description>NAC is the name of a procedure. NAC doesn't mean different interventions are used. Patients in this group need receive this NAC procedure instead of one drug before the gastrectomy and ERAS. The program consists of an intravenous injection of 130 mg/m2 oxaliplatin on day 1, followed by oral administration of 50 mg tegafur gimerac (the name of an anticarcinogen) twice daily on days 1-14, every 3 weeks.</description>
    <arm_group_label>NAC group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgery alone group</intervention_name>
    <description>Patients will not receive neoadjuvant chemotherapy and they will undergo the gastrectomy and ERAS alone.</description>
    <arm_group_label>Surgery alone group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with locally advanced gastric cancer.&#xD;
&#xD;
          2. Age older than 18 and younger than 75 years.&#xD;
&#xD;
          3. American Society of Anesthesiologists (ASA) class: I-III.&#xD;
&#xD;
          4. Participants can describe the symptom objectively and cooperate actively.&#xD;
&#xD;
          5. Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients allergic to oxaliplatin, tegafur gimerac etc.&#xD;
&#xD;
          2. Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular&#xD;
             disease, or cardiac function &gt; II (NYHA)&#xD;
&#xD;
          3. Patients with complications (bleeding, perforation and obstruction) caused by gastric&#xD;
             cancer.&#xD;
&#xD;
          4. Patients with severe liver and renal dysfunction (Child - Pugh ≥ 10; Cr &lt; 25 ml/min).&#xD;
&#xD;
          5. Patients who require simultaneous surgery for other diseases.&#xD;
&#xD;
          6. Patients who received upper abdominal surgery previously.&#xD;
&#xD;
          7. Pregnant or breast-feeding 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_official>
    <last_name>Zhi-Wei JIANG, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jinling Hospital, Medical School of Nanjing University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jian ZHAO, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Jinling Hospital, Medical School of Nanjing University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jinling Hospital, Medical School of Nanjing University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>August 2, 2017</last_update_submitted>
  <last_update_submitted_qc>August 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Jinling Hospital, China</investigator_affiliation>
    <investigator_full_name>JIANG Zhi-Wei</investigator_full_name>
    <investigator_title>Vice director of Research Institute of General Surgery</investigator_title>
  </responsible_party>
  <keyword>gastric cancer</keyword>
  <keyword>neoadjuvant chemotherapy</keyword>
  <keyword>enhanced recovery after surgery</keyword>
  <keyword>gastrectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The results and IPD will be considered to share in published articles.</ipd_description>
  </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/NCT03238404
org study id: BE2015687NAC
nct id: NCT03238404
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients with advanced gastric cancer received neoadjuvant chemotherapy undergo enhanced
      recovery after surgery (ERAS) programs.
In recent years, enhanced recovery after surgery (ERAS) programs were applied in gastrectomy
      in areas with a high prevalence of gastric cancer, such as China and Japan, confirming that
      ERAS programs accelerate the postoperative rehabilitation of gastric cancer patients without
      increasing the occurrence rate of postoperative complications. However, in most studies on
      ERAS for gastric cancer, patients who received neoadjuvant chemotherapy were excluded.
      Investigators designed this study aimed to evaluate whether patients who receive neoadjuvant
      chemotherapy can enrolled into enhanced recovery after surgery programs for locally advanced
      gastric cancer.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study is a single-center, parallel, open-label randomized controlled trial.
primary purpose: Treatment
masking: None (Open Label)
measure: Postoperative length of stay
time frame: 1 month
description: Postoperative length of stay
measure: Postoperative complications
time frame: 2 months
description: Postoperative complications
measure: The time to first flatus
time frame: 1 week
description: Bowel recovery
measure: Time to semi-liquid diet
time frame: 2 weeks
description: Bowel recovery
measure: Total protein
time frame: 1 week
description: Nutritional status
measure: Albumin
time frame: 1 week
description: Nutritional status
measure: Prealbumin
time frame: 1 week
description: Nutritional status
arm group label: NAC group
arm group type: Experimental
description: Patients will receive neoadjuvant chemotherapy (NAC) before the gastrectomy and ERAS.
arm group label: Surgery alone group
arm group type: Active Comparator
description: Patients will not receive NAC before the gastrectomy and ERAS.
intervention type: Procedure
intervention name: NAC group
description: NAC is the name of a procedure. NAC doesn't mean different interventions are used. Patients in this group need receive this NAC procedure instead of one drug before the gastrectomy and ERAS. The program consists of an intravenous injection of 130 mg/m2 oxaliplatin on day 1, followed by oral administration of 50 mg tegafur gimerac (the name of an anticarcinogen) twice daily on days 1-14, every 3 weeks.
arm group label: NAC group
intervention type: Procedure
intervention name: Surgery alone group
description: Patients will not receive neoadjuvant chemotherapy and they will undergo the gastrectomy and ERAS alone.
arm group label: Surgery alone group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Zhi-Wei JIANG, Ph.D.
role: Principal Investigator
affiliation: Jinling Hospital, Medical School of Nanjing University
last name: Jian ZHAO, Ph.D.
role: Study Director
affiliation: Jinling Hospital, Medical School of Nanjing University
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Jinling Hospital, China
investigator full name: JIANG Zhi-Wei
investigator title: Vice director of Research Institute of General Surgery
mesh term: Stomach Neoplasms
sharing ipd: Undecided
ipd description: The results and IPD will be considered to share in published articles.