<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/NCT04408859</url>
  </required_header>
  <id_info>
    <org_study_id>QOL-201804</org_study_id>
    <nct_id>NCT04408859</nct_id>
  </id_info>
  <brief_title>Quality of Life in Advanced Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy</brief_title>
  <official_title>Quality of Life in Patient With Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Cancer Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Cancer Hospital &amp; Institute</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to explore the influence of neoadjuvant chemotherapy in the long&#xD;
      term quality of life with advanced gastric cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preoperative adjuvant chemotherapy combined with postoperative adjuvant therapy mode was&#xD;
      included in the 2018 version of the National Comprehensive Cancer Network (NCCN) guideline as&#xD;
      an optional treatment (category 2B) for prospective resectable advanced gastric cancer cases&#xD;
      (≥cT2, any N).At home and abroad, the research on neoadjuvant chemotherapy for advanced&#xD;
      gastric cancer mainly focuses on the safety and long-term survival, and there are few studies&#xD;
      on the quality of life. This study, according to EORTC QLQ-C30 and QLQ-STO22 assessment&#xD;
      scale, explores the long term effect of neoadjuvant chemotherapy on the quality of life in&#xD;
      patients with advanced gastric cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 17, 2018</start_date>
  <completion_date type="Anticipated">January 10, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 10, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life index</measure>
    <time_frame>2 years</time_frame>
    <description>The change of quality of life index during the 2 years after surgery.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">290</enrollment>
  <condition>QOL; Quality of Life;Gastric Cancer; Gastrectomy;Neoadjuvant Chemotherapy</condition>
  <arm_group>
    <arm_group_label>NACS</arm_group_label>
    <description>The patients with advanced gastric cancer who received neoadjuvant chemotherapy followed by surgery（NACS）.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SA</arm_group_label>
    <description>The patients with advanced gastric cancer who received surgery alone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neoadjuvant Chemotherapy</intervention_name>
    <description>The patients receive neoadjuvant chemotherapy for 2-4 cycles before surgery.</description>
    <arm_group_label>NACS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have had curative resection at Beijing Cancer Hospital for advanced gastric&#xD;
        cancer and finish the questionnaire.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients age older than 18 years (including 18 years old);&#xD;
&#xD;
          -  Diagnosis of adenocarcinoma of the stomach&#xD;
&#xD;
          -  The clinic stage is ≥T2 and any N stage&#xD;
&#xD;
          -  Patient had curative surgical resection, including proximal, distal, or total&#xD;
             gastrectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychiatric or psychological abnormality precluding informed consent or ability to&#xD;
             complete questionnaires&#xD;
&#xD;
          -  Non-psychiatric disorder causing a lack of capacity to give consent or an inability to&#xD;
             complete questionnaires (ie dementia, stroke)&#xD;
&#xD;
          -  Early gastric cancer.&#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>Zaozao Wang</last_name>
    <phone>0086-10-88196851</phone>
    <email>zaozao83630@sina.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100010</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zaozao Wang</last_name>
      <phone>0086-10-88196851</phone>
      <email>zaozao83630@sina.com</email>
    </contact>
    <contact_backup>
      <last_name>Jianhong Yu</last_name>
      <phone>0086-10-88196851</phone>
      <email>yjh1911110624@peu.edu.cn</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University Cancer Hospital &amp; Institute</investigator_affiliation>
    <investigator_full_name>Xiangqian Su</investigator_full_name>
    <investigator_title>Chief of GI surgery IV</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>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/NCT04408859
org study id: QOL-201804
nct id: NCT04408859
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to explore the influence of neoadjuvant chemotherapy in the long
      term quality of life with advanced gastric cancer patients.
Preoperative adjuvant chemotherapy combined with postoperative adjuvant therapy mode was
      included in the 2018 version of the National Comprehensive Cancer Network (NCCN) guideline as
      an optional treatment (category 2B) for prospective resectable advanced gastric cancer cases
      (≥cT2, any N).At home and abroad, the research on neoadjuvant chemotherapy for advanced
      gastric cancer mainly focuses on the safety and long-term survival, and there are few studies
      on the quality of life. This study, according to EORTC QLQ-C30 and QLQ-STO22 assessment
      scale, explores the long term effect of neoadjuvant chemotherapy on the quality of life in
      patients with advanced gastric cancer.
observational model: Cohort
time perspective: Prospective
measure: Quality of life index
time frame: 2 years
description: The change of quality of life index during the 2 years after surgery.
arm group label: NACS
description: The patients with advanced gastric cancer who received neoadjuvant chemotherapy followed by surgery（NACS）.
arm group label: SA
description: The patients with advanced gastric cancer who received surgery alone.
intervention type: Drug
intervention name: Neoadjuvant Chemotherapy
description: The patients receive neoadjuvant chemotherapy for 2-4 cycles before surgery.
arm group label: NACS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zaozao Wang
phone: 0086-10-88196851
email: zaozao83630@sina.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University Cancer Hospital & Institute
investigator full name: Xiangqian Su
investigator title: Chief of GI surgery IV
mesh term: Stomach Neoplasms
sharing ipd: No