<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/NCT03791268</url>
  </required_header>
  <id_info>
    <org_study_id>WCH-GC-06</org_study_id>
    <nct_id>NCT03791268</nct_id>
  </id_info>
  <brief_title>General Tissue Response Classification System After Chemotherapy</brief_title>
  <official_title>The Establishment of General Tissue Response Classification System After Chemotherapy According to Gastric Cancer Patients With Neoadjuvant Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West China Hospital</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>
      This research intend to collect the information of gastric cancer patients who received&#xD;
      preoperative neoadjuvant chemotherapy and radical gastric ectomy at Department of&#xD;
      Gastrointestinal Surgery, West China Hospital, Sichuan University. Base on The degree of&#xD;
      edema, intraoperative effusion, fibrosis of connecting tissues, the investigators aim to&#xD;
      constitute the core parameters of the tissue response grading system following neoadjuvant&#xD;
      chemotherapy, and explore the mutual effect among the tissue response grading system, tumor&#xD;
      regression response and long-term survival outcome of tumor patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gastric cancer is ranked the third malignancy carcinoma which related deaths. In china,&#xD;
      gastric cancer always ranked in the top three cancer-related deaths. Early diagnosis ratio of&#xD;
      gastric caner is low in china. And the proportion of gastric cancer cases which performed&#xD;
      surgical treatment is less than 20% at early stage Therefore, the vast majority of patients&#xD;
      with gastric carcinoma already have locally advanced tumors at the time of diagnosis in&#xD;
      china, and the current treatment strategy is suggested to receive comprehensive surgical&#xD;
      gastrectomy. Current research showed strong evidence that preoperative neoadjuvant therapy&#xD;
      represented by neoadjuvant chemotherapy (NAC) can downstaging the primary tumor to increase&#xD;
      the possibility of a successful complete resection and destroying occult lymph node and&#xD;
      distant micro metastases to decrease the rate of tumor recurrence., and thus provide the&#xD;
      survival benefit for locally advanced gastric cancer patients.Therefore, the national&#xD;
      comprehensive cancer network(NCCN)guidelines for gastric cancer treatment(2017 version&#xD;
      5),recommended that neoadjuvant chemotherapy (evidential level category 1 ) and neoadjuvant&#xD;
      chemotherapy (evidential level category 2B) can be considered.for locally advanced gastric&#xD;
      caner cases(T2-4nx).&#xD;
&#xD;
      Through the literature review, the investigators found that residual tumor evaluation&#xD;
      criteria which was promoted by Becker and the criteria for tumor regression response which&#xD;
      recommended by NCCN guidelines can be used to evaluate the tumor regression after&#xD;
      chemotherapy/radiotherapy. However, the rating criteria for connective tissue response around&#xD;
      the tumor after chemotherapy/radiotherapy still remain blank area. During the clinical&#xD;
      practice, surgeons should not ignored the edema and fibrosis of tumor and connective tissue&#xD;
      after chemotherapy/radiotherapy which existed objectively. Recent research generally believed&#xD;
      that preoperative chemotherapy with/or not with radiotherapy may lead to edema of&#xD;
      gastrointestinal tract and perigastric tissues, intraoperative effusion and fibrosis of tumor&#xD;
      and lymph nodes bearing tissues，which may increase the difficulty of tissue dissociation and&#xD;
      lymph node dissection, increase the risk of surgical trauma, and may lead to increased&#xD;
      incidence of postoperative complications. There is till a lack of evaluation criteria for the&#xD;
      degree of tissue fibrosis/edema after radiotherapy and chemotherapy which may have impact on&#xD;
      surgery and long-term survival prognosis of patients.&#xD;
&#xD;
      Therefore, it is necessary to analyze and evaluate tissue edema and fibrosis after&#xD;
      chemotherapy/radiotherapy and establish corresponding criteria system to explore whether if&#xD;
      the tissue fibrosis and edema are involved with the degree of tumor retreat after&#xD;
      chemotherapy/radiotherapy at two aspects: general evaluation and histopathology. The&#xD;
      interaction effects of tissue fibrosis and edema with the difficulty of operation and&#xD;
      incidence rate of postoperative complications. In addition, the mutual effect of tissue&#xD;
      fibrosis and edema with the final long-term survival outcome of tumor patients needs to be&#xD;
      evaluated from two aspects: general observation and histopathology evaluation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>General observation of tissue fibrosis, edema and exudation (Intraoperation)</measure>
    <time_frame>The 1 day of surgery</time_frame>
    <description>To assess the degree of fibrosis, edema and exudation in tumor tissue and main perigastric lymph node area during the operation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>General observation of tissue edema (Intraoperation)</measure>
    <time_frame>The 1 day of surgery</time_frame>
    <description>To assess the degree of edema in tumor tissue and main perigastric lymph node area during the operation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General observation of tissue exudation (Intraoperation)</measure>
    <time_frame>The 1 day of surgery</time_frame>
    <description>To assess the degree of exudation in tumor tissue and main perigastric lymph node area during the operation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histopathology evaluation of edema</measure>
    <time_frame>The 1 day of surgery</time_frame>
    <description>To assess the degree of edema in tumor tissue and main perigastric lymph node area by pathological section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histopathology evaluation of tissue fibrosis</measure>
    <time_frame>Postoperative 30 days</time_frame>
    <description>To assess the degree of fibrosis in tumor tissue and main perigastric lymph node area by pathological section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative mortality rate</measure>
    <time_frame>Postoperative 30 days</time_frame>
    <description>Calculated by the number of patients with any operative complication as the numerator and the number of patients undergoing surgical treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival outcome</measure>
    <time_frame>Postoperative 3 Years</time_frame>
    <description>The 3-year overall survival rate</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Stomach Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <description>Gastric Cancer Patients who underwent Chemotherapy and will have gastric cancer surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Gastric cancer surgery</intervention_name>
    <description>Gastric cancer surgery is performed according to the Japanese Guidelines. Patients will intraoperative evaluate the edema, fibrosis and exudation.</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Gastric cancer patients who received preoperative neoadjuvant chemotherapy and radical&#xD;
        gastric ectomy at Department of Gastrointestinal Surgery, West China Hospital, Sichuan&#xD;
        University&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The diagnosis of gastric cancer was clear，Patients with definitely clinical evidence&#xD;
             of locally advanced disease (cT3 ⁄ 4、N-/+、M0).&#xD;
&#xD;
          2. Preoperative chemotherapy has been administered，and intended to receive surgical&#xD;
             resection.&#xD;
&#xD;
          3. Age:less than or equal to 75 years old and more than 18 years old;&#xD;
&#xD;
          4. Without any other malignant tumor, without any serious concomitant disease.&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group (ECOG) physical status score &lt;2, America Society of&#xD;
             Anesthesiologist (ASA) score&lt;3&#xD;
&#xD;
          6. No restriction on gender or race; Informed consent has been signed by patient or&#xD;
             entrusted agent；&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous history of gastric ulcer or gastric perforation;&#xD;
&#xD;
          2. Previous operation history at upper abdominal, except laparoscopic cholecystectomy;&#xD;
&#xD;
          3. Emergency operation caused by obstruction, perforation,and acute hemorrhage;&#xD;
&#xD;
          4. The patient can not tolerate the surgical treatment which caused by other serious&#xD;
             concomitant disease, such as severe pulmonary disease, cardiac clinical function below&#xD;
             are below level 2, pulmonary infection, moderate or severe chronic obstructive&#xD;
             pulmonary disease (COPD), chronic bronchitis&#xD;
&#xD;
          5. Patient has severe mental illness&#xD;
&#xD;
          6. The patient and agent request to withdraw from the clinical study after signing the&#xD;
             consent form.&#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>Jian-Kun Hu, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West China Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jian-Kun Hu, MD, PhD</last_name>
    <phone>02885422878</phone>
    <email>hujkwch@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wei-Han Zhang, MD, PhD</last_name>
    <phone>02885422480</phone>
    <email>weihanwch@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>West China Hospital, Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>December 31, 2018</last_update_submitted>
  <last_update_submitted_qc>December 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West China Hospital</investigator_affiliation>
    <investigator_full_name>Jian-Kun Hu</investigator_full_name>
    <investigator_title>Vice director of Gastrointestinal Surgery department, West China Hospital; Director of Institute of Gastric Cancer, State Key Laboratory of Biotherapy, West China Hospital</investigator_title>
  </responsible_party>
  <keyword>Stomach Adenocarcinoma</keyword>
  <keyword>neoadjuvant chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03791268
org study id: WCH-GC-06
nct id: NCT03791268
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This research intend to collect the information of gastric cancer patients who received
      preoperative neoadjuvant chemotherapy and radical gastric ectomy at Department of
      Gastrointestinal Surgery, West China Hospital, Sichuan University. Base on The degree of
      edema, intraoperative effusion, fibrosis of connecting tissues, the investigators aim to
      constitute the core parameters of the tissue response grading system following neoadjuvant
      chemotherapy, and explore the mutual effect among the tissue response grading system, tumor
      regression response and long-term survival outcome of tumor patients.
Gastric cancer is ranked the third malignancy carcinoma which related deaths. In china,
      gastric cancer always ranked in the top three cancer-related deaths. Early diagnosis ratio of
      gastric caner is low in china. And the proportion of gastric cancer cases which performed
      surgical treatment is less than 20% at early stage Therefore, the vast majority of patients
      with gastric carcinoma already have locally advanced tumors at the time of diagnosis in
      china, and the current treatment strategy is suggested to receive comprehensive surgical
      gastrectomy. Current research showed strong evidence that preoperative neoadjuvant therapy
      represented by neoadjuvant chemotherapy (NAC) can downstaging the primary tumor to increase
      the possibility of a successful complete resection and destroying occult lymph node and
      distant micro metastases to decrease the rate of tumor recurrence., and thus provide the
      survival benefit for locally advanced gastric cancer patients.Therefore, the national
      comprehensive cancer network(NCCN)guidelines for gastric cancer treatment(2017 version
      5),recommended that neoadjuvant chemotherapy (evidential level category 1 ) and neoadjuvant
      chemotherapy (evidential level category 2B) can be considered.for locally advanced gastric
      caner cases(T2-4nx).

      Through the literature review, the investigators found that residual tumor evaluation
      criteria which was promoted by Becker and the criteria for tumor regression response which
      recommended by NCCN guidelines can be used to evaluate the tumor regression after
      chemotherapy/radiotherapy. However, the rating criteria for connective tissue response around
      the tumor after chemotherapy/radiotherapy still remain blank area. During the clinical
      practice, surgeons should not ignored the edema and fibrosis of tumor and connective tissue
      after chemotherapy/radiotherapy which existed objectively. Recent research generally believed
      that preoperative chemotherapy with/or not with radiotherapy may lead to edema of
      gastrointestinal tract and perigastric tissues, intraoperative effusion and fibrosis of tumor
      and lymph nodes bearing tissues，which may increase the difficulty of tissue dissociation and
      lymph node dissection, increase the risk of surgical trauma, and may lead to increased
      incidence of postoperative complications. There is till a lack of evaluation criteria for the
      degree of tissue fibrosis/edema after radiotherapy and chemotherapy which may have impact on
      surgery and long-term survival prognosis of patients.

      Therefore, it is necessary to analyze and evaluate tissue edema and fibrosis after
      chemotherapy/radiotherapy and establish corresponding criteria system to explore whether if
      the tissue fibrosis and edema are involved with the degree of tumor retreat after
      chemotherapy/radiotherapy at two aspects: general evaluation and histopathology. The
      interaction effects of tissue fibrosis and edema with the difficulty of operation and
      incidence rate of postoperative complications. In addition, the mutual effect of tissue
      fibrosis and edema with the final long-term survival outcome of tumor patients needs to be
      evaluated from two aspects: general observation and histopathology evaluation.
observational model: Case-Only
time perspective: Prospective
measure: General observation of tissue fibrosis, edema and exudation (Intraoperation)
time frame: The 1 day of surgery
description: To assess the degree of fibrosis, edema and exudation in tumor tissue and main perigastric lymph node area during the operation.
measure: General observation of tissue edema (Intraoperation)
time frame: The 1 day of surgery
description: To assess the degree of edema in tumor tissue and main perigastric lymph node area during the operation.
measure: General observation of tissue exudation (Intraoperation)
time frame: The 1 day of surgery
description: To assess the degree of exudation in tumor tissue and main perigastric lymph node area during the operation.
measure: Histopathology evaluation of edema
time frame: The 1 day of surgery
description: To assess the degree of edema in tumor tissue and main perigastric lymph node area by pathological section.
measure: Histopathology evaluation of tissue fibrosis
time frame: Postoperative 30 days
description: To assess the degree of fibrosis in tumor tissue and main perigastric lymph node area by pathological section.
measure: Postoperative mortality rate
time frame: Postoperative 30 days
description: Calculated by the number of patients with any operative complication as the numerator and the number of patients undergoing surgical treatment.
measure: Survival outcome
time frame: Postoperative 3 Years
description: The 3-year overall survival rate
arm group label: Group A
description: Gastric Cancer Patients who underwent Chemotherapy and will have gastric cancer surgery.
intervention type: Procedure
intervention name: Gastric cancer surgery
description: Gastric cancer surgery is performed according to the Japanese Guidelines. Patients will intraoperative evaluate the edema, fibrosis and exudation.
arm group label: Group A
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jian-Kun Hu, MD, PhD
role: Principal Investigator
affiliation: West China Hospital
last name: Jian-Kun Hu, MD, PhD
phone: 02885422878
email: hujkwch@126.com
last name: Wei-Han Zhang, MD, PhD
phone: 02885422480
email: weihanwch@126.com
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: West China Hospital
investigator full name: Jian-Kun Hu
investigator title: Vice director of Gastrointestinal Surgery department, West China Hospital; Director of Institute of Gastric Cancer, State Key Laboratory of Biotherapy, West China Hospital
mesh term: Adenocarcinoma
sharing ipd: Undecided