<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/NCT03272984</url>
  </required_header>
  <id_info>
    <org_study_id>8150041701</org_study_id>
    <nct_id>NCT03272984</nct_id>
  </id_info>
  <brief_title>ERAS for Patients Received Neoadjuvant Chemotherapy</brief_title>
  <acronym>ERASNAC</acronym>
  <official_title>Enhanced Recovery After Surgery Programs for Patients Received Neoadjuvant Chemotherapy With Locally Advanced Gastric Cancer: a Randomized Controlled Clinical Trial</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 received neoadjuvant chemotherapy with locally advanced gastric caner undergo the&#xD;
      enhanced recovery after surgery (ERAS) programs or the standard cares (SC) programs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Before, most trials about the ERAS for radical gastrectomy demonstrated ERAS programs&#xD;
      accelerate the postoperative rehabilitation of gastric cancer patients without increasing&#xD;
      postoperative complications. However, in most trials, patients who received neoadjuvant&#xD;
      chemotherapy were excluded. The investigators designed this trial for patients received&#xD;
      neoadjuvant chemotherapy. In this trial, patients received neoadjuvant chemotherapy with&#xD;
      locally advanced gastric caner undergo the ERAS programs or the SC programs. Finally, the&#xD;
      investigators evaluated whether patients who receive neoadjuvant chemotherapy can be enrolled&#xD;
      into the ERAS programs for locally advanced gastric cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2015</start_date>
  <completion_date type="Actual">July 6, 2017</completion_date>
  <primary_completion_date type="Actual">June 5, 2017</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 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 week</time_frame>
    <description>Bowel recovery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>ERAS group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will undergo the ERAS programs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SC group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients will undergo the SC group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ERAS group</intervention_name>
    <description>ERAS is the name of a procedure. Patients in this group need receive the ERAS procedure instead of one drug.</description>
    <arm_group_label>ERAS group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SC group</intervention_name>
    <description>Patients were managed in accordance with SC programs during the perioperative period. SC programs were used daily in our center and were still routinely used in most of the other hospitals in China.</description>
    <arm_group_label>SC group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients received neoadjuvant chemotherapy 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>Zhiwei JIANG, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jinling Hospital, Medical School of Nanjing University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jian ZHAO, MD</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>September 2017</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 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>
  <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/NCT03272984
org study id: 8150041701
nct id: NCT03272984
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients received neoadjuvant chemotherapy with locally advanced gastric caner undergo the
      enhanced recovery after surgery (ERAS) programs or the standard cares (SC) programs.
Before, most trials about the ERAS for radical gastrectomy demonstrated ERAS programs
      accelerate the postoperative rehabilitation of gastric cancer patients without increasing
      postoperative complications. However, in most trials, patients who received neoadjuvant
      chemotherapy were excluded. The investigators designed this trial for patients received
      neoadjuvant chemotherapy. In this trial, patients received neoadjuvant chemotherapy with
      locally advanced gastric caner undergo the ERAS programs or the SC programs. Finally, the
      investigators evaluated whether patients who receive neoadjuvant chemotherapy can be enrolled
      into the ERAS programs for locally advanced gastric cancer.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study is a 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 week
description: Bowel recovery
arm group label: ERAS group
arm group type: Experimental
description: Patients will undergo the ERAS programs.
arm group label: SC group
arm group type: Other
description: Patients will undergo the SC group.
intervention type: Procedure
intervention name: ERAS group
description: ERAS is the name of a procedure. Patients in this group need receive the ERAS procedure instead of one drug.
arm group label: ERAS group
intervention type: Procedure
intervention name: SC group
description: Patients were managed in accordance with SC programs during the perioperative period. SC programs were used daily in our center and were still routinely used in most of the other hospitals in China.
arm group label: SC group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Zhiwei JIANG, MD
role: Principal Investigator
affiliation: Jinling Hospital, Medical School of Nanjing University
last name: Jian ZHAO, MD
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.