<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/NCT01711242</url>
  </required_header>
  <id_info>
    <org_study_id>WZMC-12068</org_study_id>
    <nct_id>NCT01711242</nct_id>
  </id_info>
  <brief_title>Trial of Adjuvant XELOX Chemotherapy and Concurrent Capecitabine and Radiotherapy for Resected Gastric Carcinoma</brief_title>
  <official_title>Phase II Randomized Trial of Adjuvant XELOX Chemotherapy and XELOX With Concurrent Capecitabine and Radiotherapy for Gastric Adenocarcinoma With D2 Dissection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>xie congying</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wenzhou Medical University</source>
  <brief_summary>
    <textblock>
      The objective of the trial is to compare disease-free survival between adjuvant XELOX alone&#xD;
      vs XELOX with concurrent capecitabine and radiotherapy in curatively resected gastric cancer&#xD;
      patients with D2 dissection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gastric cancer is one of the most common malignancies in China. Complete surgical resection&#xD;
      is the only potentially curative therapy available to patients with gastric cancer. However,&#xD;
      the overall survival results remain unsatisfactory. The main factor accounting for high&#xD;
      mortality rate is the relapse after surgical resection. During the past few decades, the&#xD;
      principle of combined modality treatment has been developed and applied in gastric cancer.&#xD;
      Radiation therapy plus concurrent chemotherapy had demonstrated to be able to achieve a&#xD;
      significant improvement in overall and disease-free survival according to Intergroup Trial&#xD;
      0116/Southwest Oncology Group 9008. Nevertheless, the result from Intergroup Trial 0116 study&#xD;
      had been challenged by the fact that the surgical treatment applied in the trial was&#xD;
      gastrectomy with limited lymph node dissection (D0 or D1) in 90% of cases. Therefore, it is&#xD;
      debatable whether adjuvant chemoradiation therapy can confer survival benefit in patients&#xD;
      with extensive lymph node dissection. In ARTIST study, the addition of concurrent&#xD;
      capecitabine and radiotherapy to capecitabine and cisplatin chemotherapy did not&#xD;
      significantly reduce recurrence after curative resection and D2 lymph node dissection in&#xD;
      gastric cancer. In subgroup analysis of patients with positive pathologic lymphnodes, there&#xD;
      was a statistically significant prolongation in disease-free survival in the concurrent&#xD;
      treatment arm when compared with the chemotherapy alone arm. Furthermore, CLASSIC study&#xD;
      showed that XELOX (oxaliplatin/capecitabine) combination given as adjuvant chemotherapy for&#xD;
      stage II or III patients after D2 surgery could achieve a significant survival benefit. The&#xD;
      standard treatment modality in gastric cancer after D2 dissection is still disputable. Thus,&#xD;
      the assessment of the effect of adjuvant sequence chemoradiotherapy in D2 resected gastric&#xD;
      cancer is essential.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2012</start_date>
  <completion_date type="Actual">January 2021</completion_date>
  <primary_completion_date type="Actual">January 2020</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>disease free survival</measure>
    <time_frame>3-year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>5 year Overall Survival</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>five years after enrollment</time_frame>
    <description>assessed by the Functional Assessment of Cancer Therapy-Esophageal (FACT-E)</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of participants with adverse events as a measure of safety and tolerability</measure>
    <time_frame>during treatment</time_frame>
    <description>assessed by NCI Common Terminology Criteria v3.0</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">208</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>capecitabine/Oxaliplatin/radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>sequence chemoradiotherapy following radical resection&#xD;
sequence chemoradiotherapy two cycles of XELOX + concurrent chemoradiotherapy + two cycles of XELOX.&#xD;
Postoperative radiotherapy regimen: Radiotherapy consisted of 4500 centigray of radiation at 180 centigray per day, five days per week for five weeks, to the tumor bed, to the margins of resection or the stoma, to the regional nodes. Protection of spinal cord, heart, liver and kidney should be considered.&#xD;
Concurrent chemotherapy regimen: capecitabine 825 mg/m² twice daily Postoperative chemotherapy regimen: see arm 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>capecitabine/Oxaliplatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>chemotherapy alone following radical resection&#xD;
Drug: chemotherapy alone following radical resection Postoperative chemotherapy regimen: The XELOX regimen was administrated: Oxaliplatin, 130mg/m2/day on day1, i.v. 2h; Capecitabine 1000mg/m²/day twice daily d1-14; every 21 days repeated, for 4 cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <arm_group_label>capecitabine/Oxaliplatin</arm_group_label>
    <arm_group_label>capecitabine/Oxaliplatin/radiotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <arm_group_label>capecitabine/Oxaliplatin</arm_group_label>
    <arm_group_label>capecitabine/Oxaliplatin/radiotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy</intervention_name>
    <arm_group_label>capecitabine/Oxaliplatin/radiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven gastric cancer; ≥ D2 resection&#xD;
&#xD;
          -  Stage T1-4, N+&#xD;
&#xD;
          -  18 ≤ age ≤ 75&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group 0-2&#xD;
&#xD;
          -  No distant metastasis&#xD;
&#xD;
          -  Adequate bone marrow functions (absolute neutrophil count≥ 1,500/ul, blood platelet≥&#xD;
             100,000/ul, haemoglobin≥ 10g/dl)&#xD;
&#xD;
          -  Adequate renal functions(serum creatinine ≤ 1.5mg/dl)&#xD;
&#xD;
          -  Adequate liver functions (serum bilirubin ≤ 1.5mg/dl, aspartate&#xD;
             aminotransferase/alanine aminotransferase ≤ 3 times(normal value)&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous history of immunotherapy, chemotherapy, radiotherapy for gastric cancer;&#xD;
&#xD;
          -  Active infection requiring antibiotics;&#xD;
&#xD;
          -  Pregnant, lactating women;&#xD;
&#xD;
          -  Psychiatric illness, epileptic disorders;&#xD;
&#xD;
          -  Concurrent systemic illness not appropriate for chemotherapy;&#xD;
&#xD;
          -  Resection margin (+);&#xD;
&#xD;
          -  History of other malignancy within 5 years except for non-melanoma skin cancer, cervix&#xD;
             in situ carcinoma;&#xD;
&#xD;
          -  D0, D1 resection;&#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>congying xie, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital of Wenzhou Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>xiaolei chen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital of Wenzhou Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Wenzhou Medical College</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>October 14, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>April 29, 2022</last_update_submitted>
  <last_update_submitted_qc>April 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Wenzhou Medical University</investigator_affiliation>
    <investigator_full_name>xie congying</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>gastric cancer</keyword>
  <keyword>radiotherapy</keyword>
  <keyword>postoperative therapy</keyword>
  <keyword>chemotherapy</keyword>
  <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>Capecitabine</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01711242
org study id: WZMC-12068
nct id: NCT01711242
lead sponsor: 
The objective of the trial is to compare disease-free survival between adjuvant XELOX alone
      vs XELOX with concurrent capecitabine and radiotherapy in curatively resected gastric cancer
      patients with D2 dissection.
Gastric cancer is one of the most common malignancies in China. Complete surgical resection
      is the only potentially curative therapy available to patients with gastric cancer. However,
      the overall survival results remain unsatisfactory. The main factor accounting for high
      mortality rate is the relapse after surgical resection. During the past few decades, the
      principle of combined modality treatment has been developed and applied in gastric cancer.
      Radiation therapy plus concurrent chemotherapy had demonstrated to be able to achieve a
      significant improvement in overall and disease-free survival according to Intergroup Trial
      0116/Southwest Oncology Group 9008. Nevertheless, the result from Intergroup Trial 0116 study
      had been challenged by the fact that the surgical treatment applied in the trial was
      gastrectomy with limited lymph node dissection (D0 or D1) in 90% of cases. Therefore, it is
      debatable whether adjuvant chemoradiation therapy can confer survival benefit in patients
      with extensive lymph node dissection. In ARTIST study, the addition of concurrent
      capecitabine and radiotherapy to capecitabine and cisplatin chemotherapy did not
      significantly reduce recurrence after curative resection and D2 lymph node dissection in
      gastric cancer. In subgroup analysis of patients with positive pathologic lymphnodes, there
      was a statistically significant prolongation in disease-free survival in the concurrent
      treatment arm when compared with the chemotherapy alone arm. Furthermore, CLASSIC study
      showed that XELOX (oxaliplatin/capecitabine) combination given as adjuvant chemotherapy for
      stage II or III patients after D2 surgery could achieve a significant survival benefit. The
      standard treatment modality in gastric cancer after D2 dissection is still disputable. Thus,
      the assessment of the effect of adjuvant sequence chemoradiotherapy in D2 resected gastric
      cancer is essential.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: disease free survival
time frame: 3-year
measure: 5 year Overall Survival
time frame: 5 years
measure: Health-related quality of life
time frame: five years after enrollment
description: assessed by the Functional Assessment of Cancer Therapy-Esophageal (FACT-E)
measure: Number of participants with adverse events as a measure of safety and tolerability
time frame: during treatment
description: assessed by NCI Common Terminology Criteria v3.0
arm group label: capecitabine/Oxaliplatin/radiotherapy
arm group type: Experimental
description: sequence chemoradiotherapy following radical resection
sequence chemoradiotherapy two cycles of XELOX + concurrent chemoradiotherapy + two cycles of XELOX.
Postoperative radiotherapy regimen: Radiotherapy consisted of 4500 centigray of radiation at 180 centigray per day, five days per week for five weeks, to the tumor bed, to the margins of resection or the stoma, to the regional nodes. Protection of spinal cord, heart, liver and kidney should be considered.
Concurrent chemotherapy regimen: capecitabine 825 mg/m² twice daily Postoperative chemotherapy regimen: see arm 2
arm group label: capecitabine/Oxaliplatin
arm group type: Active Comparator
description: chemotherapy alone following radical resection
Drug: chemotherapy alone following radical resection Postoperative chemotherapy regimen: The XELOX regimen was administrated: Oxaliplatin, 130mg/m2/day on day1, i.v. 2h; Capecitabine 1000mg/m²/day twice daily d1-14; every 21 days repeated, for 4 cycles.
intervention type: Drug
intervention name: Capecitabine
arm group label: capecitabine/Oxaliplatin
arm group label: capecitabine/Oxaliplatin/radiotherapy
intervention type: Drug
intervention name: Oxaliplatin
arm group label: capecitabine/Oxaliplatin
arm group label: capecitabine/Oxaliplatin/radiotherapy
intervention type: Radiation
intervention name: Radiotherapy
arm group label: capecitabine/Oxaliplatin/radiotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: congying xie, MD
role: Principal Investigator
affiliation: First Affiliated Hospital of Wenzhou Medical University
last name: xiaolei chen, MD
role: Principal Investigator
affiliation: First Affiliated Hospital of Wenzhou Medical University
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Wenzhou Medical University
investigator full name: xie congying
investigator title: Director
mesh term: Stomach Neoplasms
mesh term: Capecitabine
mesh term: Oxaliplatin