<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/NCT01674959</url>
  </required_header>
  <id_info>
    <org_study_id>2011 CH-GI-024</org_study_id>
    <nct_id>NCT01674959</nct_id>
  </id_info>
  <brief_title>Postoperative IMRT Combined With Capecitabine for Advanced Gastric Cancer Patients</brief_title>
  <official_title>Phase II Study of Postoperative Intensity-modulated Radiotherapy (IMRT) Combined With Capecitabine for Stage II/III Gastric Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Radiation therapy plus concurrent chemotherapy has been demonstrated a significant&#xD;
      improvement in overall and disease-free survival according to Intergroup Trial 0116 in&#xD;
      patients with gastric cancer after surgical complete resection. Advantage of application of&#xD;
      IMRT has been shown in planning comparison studies for postoperative gastric patients. So the&#xD;
      investigators designed the trial to see safety and efficacy of postoperative concurrent&#xD;
      chemoradiotherapy of capecitabine combined with IMRT for stage II/II gastric cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Intergroup 0116, only 64% patients in concurrent chemoradiation group completed treatment&#xD;
      as planed, but in recently reported ARTIST trial, capecitabine was admitted to concurrent&#xD;
      with radiotherapy,patients who completed treatment as planed in concurrent group reach high&#xD;
      as 80%. IMRT is an advanced radiotherapy technology which allows high conformal dose&#xD;
      distribution to Planing Tumor Volume (PTV) and low dose to organ at risk. The purpose of this&#xD;
      study is to evaluate feasibility and efficacy of concurrent IMRT combined with capecitabine&#xD;
      for the treatment of gastric cancer patients after D1/2 surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2011</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>feasibility of concurrent IMRT combined with capecitabine for the treatment of gastric cancer patients</measure>
    <time_frame>3 months after concurrent chemoradiation</time_frame>
    <description>feasibility of concurrent IMRT combined with capecitabine is defined as toxicities (CTC-AE 3.0) and rate of patients complete concurrent chemoradiation according to protocol.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>efficacy of concurrent IMRT combined with capecitabine for the treatment of gastric cancer patients</measure>
    <time_frame>3 years after concurrent chemoradiation</time_frame>
    <description>efficacy of concurrent IMRT combined with capecitabine for the treatment of gastric cancer patients in this trial is defined as 3-year overall survival and 3-year relapse free survival.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>concurrent chemoradiation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>• Radiation: concurrent chemoradiotherapy Postoperative radiotherapy regimen: Therapy plan system was formulated by Computed tomographic (CT) simulation. Radiation was delivered with 6MV photons. Radiotherapy consisted of 4500 cGy of radiation at 180 cGy 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;
Postoperative current chemotherapy regimen: capecitabine( 1,600 mg/m2 per day for 5 weeks).</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>concurrent chemoradiation</intervention_name>
    <description>postoperative Intensity-modulated radiotherapy (IMRT) combined with capecitabine for high risk gastric cancer patients Radiation: concurrent chemoradiotherapy Postoperative radiotherapy regimen: Therapy plan system was formulated by Computed tomographic (CT) simulation. Radiation was delivered with 6MV photons. Radiotherapy consisted of 4500 cGy of radiation at 180 cGy 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;
Postoperative chemotherapy regimen: capecitabine( 1,600 mg/m2 per day for 5 weeks).</description>
    <arm_group_label>concurrent chemoradiation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Postoperative histologically confirmed advanced adenocarcinoma of the stomach or the&#xD;
             gastroesophageal junction.&#xD;
&#xD;
          2. Age of 18 to 75, Karnofsky score higher than 70.&#xD;
&#xD;
          3. Postoperative histologically conformed metastasis in perigastric lymph nodes and/or&#xD;
             tumor invasion to muscularis propria or subserosa, without positive incisal margin.&#xD;
             Stage II/III(AJCC 7th).&#xD;
&#xD;
          4. No severe functional damage of major organ, normal blood cell, normal liver and kidney&#xD;
             function.&#xD;
&#xD;
          5. No clinical findings of distant metastasis.&#xD;
&#xD;
          6. Predictive survival time longer than 6 months.&#xD;
&#xD;
             -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Peritoneal carcinomatosis, as diagnosed by mandatory laparoscopy or distant metastasis&#xD;
&#xD;
          2. Concurrent treatment with other experimental drugs or other anti-cancer therapy, or&#xD;
             treatment within a clinical trial within 30 days prior to trial entry&#xD;
&#xD;
          3. Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or&#xD;
             IV, no myocardial infarction within the last 12 months, unstable angina pectoris, or&#xD;
             significant arrhythmia)&#xD;
&#xD;
          4. Active or uncontrolled infection.&#xD;
&#xD;
          5. Definitive contraindications for the use of corticosteroids as premedication&#xD;
&#xD;
          6. Prior systemic (chemo- or targeted) treatment. Prior radiotherapy to the upper abdomen&#xD;
&#xD;
          7. Any contraindication to treatment with cetuximab, capecitabine or cisplatin&#xD;
&#xD;
          8. Previous malignancy within 5 years, with the exception of adequately treated cervical&#xD;
             carcinoma in situ or localized non-melanoma skin cancer&#xD;
&#xD;
          9. Known hypersensitivity against any of the study drugs ( capecitabine)&#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>jing jin, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Hospital, Chinese Academy of Medical Science</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>jing jin</last_name>
    <phone>8610-87788280</phone>
    <email>jingjin1025@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>hua ren</last_name>
    <phone>8610-87788122</phone>
    <email>renhua2009@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dept of Radiation oncology, Cancer Hospital , Chinese Academy of Medical Science</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>jing jin</last_name>
      <phone>8610-87788280</phone>
      <email>jingjin1025@163.com</email>
    </contact>
    <contact_backup>
      <last_name>hua ren</last_name>
      <phone>8610-87788122</phone>
      <email>renhua2009@hotmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>jing jin, professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>August 26, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>February 3, 2015</last_update_submitted>
  <last_update_submitted_qc>February 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 5, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Jing Jin, M.D.</investigator_full_name>
    <investigator_title>Attending doctor of Dept. radiation oncology, Cancer Hospital</investigator_title>
  </responsible_party>
  <keyword>gastric cancer</keyword>
  <keyword>radiation</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>
  <!-- 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/NCT01674959
org study id: 2011 CH-GI-024
nct id: NCT01674959
lead sponsor: 
has dmc: No
Radiation therapy plus concurrent chemotherapy has been demonstrated a significant
      improvement in overall and disease-free survival according to Intergroup Trial 0116 in
      patients with gastric cancer after surgical complete resection. Advantage of application of
      IMRT has been shown in planning comparison studies for postoperative gastric patients. So the
      investigators designed the trial to see safety and efficacy of postoperative concurrent
      chemoradiotherapy of capecitabine combined with IMRT for stage II/II gastric cancer.
In Intergroup 0116, only 64% patients in concurrent chemoradiation group completed treatment
      as planed, but in recently reported ARTIST trial, capecitabine was admitted to concurrent
      with radiotherapy,patients who completed treatment as planed in concurrent group reach high
      as 80%. IMRT is an advanced radiotherapy technology which allows high conformal dose
      distribution to Planing Tumor Volume (PTV) and low dose to organ at risk. The purpose of this
      study is to evaluate feasibility and efficacy of concurrent IMRT combined with capecitabine
      for the treatment of gastric cancer patients after D1/2 surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: feasibility of concurrent IMRT combined with capecitabine for the treatment of gastric cancer patients
time frame: 3 months after concurrent chemoradiation
description: feasibility of concurrent IMRT combined with capecitabine is defined as toxicities (CTC-AE 3.0) and rate of patients complete concurrent chemoradiation according to protocol.
measure: efficacy of concurrent IMRT combined with capecitabine for the treatment of gastric cancer patients
time frame: 3 years after concurrent chemoradiation
description: efficacy of concurrent IMRT combined with capecitabine for the treatment of gastric cancer patients in this trial is defined as 3-year overall survival and 3-year relapse free survival.
arm group label: concurrent chemoradiation
arm group type: Experimental
description: • Radiation: concurrent chemoradiotherapy Postoperative radiotherapy regimen: Therapy plan system was formulated by Computed tomographic (CT) simulation. Radiation was delivered with 6MV photons. Radiotherapy consisted of 4500 cGy of radiation at 180 cGy 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.
Postoperative current chemotherapy regimen: capecitabine( 1,600 mg/m2 per day for 5 weeks).
intervention type: Radiation
intervention name: concurrent chemoradiation
description: postoperative Intensity-modulated radiotherapy (IMRT) combined with capecitabine for high risk gastric cancer patients Radiation: concurrent chemoradiotherapy Postoperative radiotherapy regimen: Therapy plan system was formulated by Computed tomographic (CT) simulation. Radiation was delivered with 6MV photons. Radiotherapy consisted of 4500 cGy of radiation at 180 cGy 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.
Postoperative chemotherapy regimen: capecitabine( 1,600 mg/m2 per day for 5 weeks).
arm group label: concurrent chemoradiation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: jing jin, professor
role: Principal Investigator
affiliation: Cancer Hospital, Chinese Academy of Medical Science
last name: jing jin
phone: 8610-87788280
email: jingjin1025@163.com
last name: hua ren
phone: 8610-87788122
email: renhua2009@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Jing Jin, M.D.
investigator title: Attending doctor of Dept. radiation oncology, Cancer Hospital
mesh term: Stomach Neoplasms