<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/NCT02193594</url>
  </required_header>
  <id_info>
    <org_study_id>CRADLE</org_study_id>
    <nct_id>NCT02193594</nct_id>
  </id_info>
  <brief_title>Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma</brief_title>
  <official_title>Phase Ⅱ/Ⅲ Study of Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Preoperative chemoradiotherapy(CRT) had been introduced in the comprehensive treatment of&#xD;
      gastroesophageal junction and upper gastric cancers in the decade.According to some&#xD;
      researches,CRT had shown its good curative effects in local control and prolonged overall&#xD;
      survival.However,the optimization scheme for CRT and its influence to surgery remains&#xD;
      controversial.Meanwhile,there were many design flaws in the past few research,such as the&#xD;
      lack of adjuvant chemotherapy,the insufficiency in lymphnodes dissection.We decided to carry&#xD;
      out the trial,eliminating all the bias as far as we can,to illustrate the efficacy and safety&#xD;
      of CRT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">May 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2017</primary_completion_date>
  <phase>Phase 2/Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The patient's survival time and recurrence time</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>3-year overall survival&#xD;
1-year and 3-year recurrence free survival</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The number of patients with complications</measure>
    <time_frame>Within 30 days after the day of operation</time_frame>
    <description>the morbidity and mortality rates within 30 days after the day of operation</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The pathologic profiles and the pathologic response rates</measure>
    <time_frame>Within 30 days after the day of operation</time_frame>
    <description>the pathologic profiles and the pathologic response rates</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">214</enrollment>
  <condition>Gastroesophageal Junction Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>CCRT group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patient in CCRT group will receive the preoperative concurrent chemoradiotherapy for 5 weeks and sequential radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 6 cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CT group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patient in CT group will receive radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 8 cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Preoperative concurrent chemoradiotherapy</intervention_name>
    <description>The patients will receive radiotherapy in the total amount of 50Gy(25 fractions) preoperatively,concurrently combined with chemotherapy,which consist of oxaliplatin 40mg/m2 administrated on days 1,8,15,22,29 and S-1® 30mg/m2 twice per day on days 1 to 5 per week.</description>
    <arm_group_label>CCRT group</arm_group_label>
    <other_name>CCRT</other_name>
    <other_name>Eloxatin®</other_name>
    <other_name>S-1®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radical D2 total gastrectomy</intervention_name>
    <description>Within 5-6 weeks after the completion of neoadjuvant therapy,the patients in CCRT group will receive the radical total gastrectomy with D2 lymphadenectomy,and patients in the CT group will receive the surgery right after randomization.</description>
    <arm_group_label>CCRT group</arm_group_label>
    <arm_group_label>CT group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adjuvant chemotherapy</intervention_name>
    <description>Within 2 months after surgery,the patients will receive chemotherapy for 6 to 8 cycles ,consist of oxaliplatin 130mg/m2 administrated on day1 and S-1® 40-60mg twice per day on days 1 to 14 per 3 weeks.The S-1® dosage depends on the patient BSA(BSA&lt;1.25m2 40mg,1.25 m2≤BSA≤1.5 m2 50mg ,BSA&gt;1.5 m2 60mg). Patients in the CCRT group will receive 6 cycles of chemotherapy and patients in the CT group will receive 8 cycles of chemotherapy.</description>
    <arm_group_label>CCRT group</arm_group_label>
    <arm_group_label>CT group</arm_group_label>
    <other_name>Eloxatin®</other_name>
    <other_name>S-1®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven adenocarcinoma of the gastroesophageal junction.&#xD;
&#xD;
          -  Clinical stage diagnosed by endoscopic ultrasound(EUS) or computed tomography(CT) as&#xD;
             T3-4NxM0 tumors,according to American Joint Committee on Cancer (AJCC) 7th edition.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status≤2.&#xD;
&#xD;
          -  Informed consent obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Combined with other malignant tumors.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status&gt;2.&#xD;
&#xD;
          -  Combined with severe organ dysfunction.&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiafu Ji, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Cancer Hospital &amp; Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jiafu Ji, M.D.</last_name>
    <email>jiafuj@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Haidian District</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shuangxi Li, M.D.</last_name>
      <email>lishuangxi@outlook.com</email>
    </contact>
    <investigator>
      <last_name>Jiafu Ji, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ziyu Li, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Shuangxi Li, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>June 4, 2015</last_update_submitted>
  <last_update_submitted_qc>June 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Jiafu Ji</investigator_full_name>
    <investigator_title>President of Beijing Cancer Hospital,Director of Key Laboratory of Carcinogenesis and Translational Research(Gastric Cancer Laboratory)</investigator_title>
  </responsible_party>
  <keyword>Preoperative concurrent chemoradiotherapy</keyword>
  <keyword>Neoadjuvant chemoradiotherapy</keyword>
  <keyword>Gastroesophageal junction adenocarcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Esophageal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02193594
org study id: CRADLE
nct id: NCT02193594
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Preoperative chemoradiotherapy(CRT) had been introduced in the comprehensive treatment of
      gastroesophageal junction and upper gastric cancers in the decade.According to some
      researches,CRT had shown its good curative effects in local control and prolonged overall
      survival.However,the optimization scheme for CRT and its influence to surgery remains
      controversial.Meanwhile,there were many design flaws in the past few research,such as the
      lack of adjuvant chemotherapy,the insufficiency in lymphnodes dissection.We decided to carry
      out the trial,eliminating all the bias as far as we can,to illustrate the efficacy and safety
      of CRT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The patient's survival time and recurrence time
time frame: Up to 3 years
description: 3-year overall survival
1-year and 3-year recurrence free survival
measure: The number of patients with complications
time frame: Within 30 days after the day of operation
description: the morbidity and mortality rates within 30 days after the day of operation
measure: The pathologic profiles and the pathologic response rates
time frame: Within 30 days after the day of operation
description: the pathologic profiles and the pathologic response rates
arm group label: CCRT group
arm group type: Experimental
description: The patient in CCRT group will receive the preoperative concurrent chemoradiotherapy for 5 weeks and sequential radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 6 cycles.
arm group label: CT group
arm group type: Active Comparator
description: The patient in CT group will receive radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 8 cycles.
intervention type: Radiation
intervention name: Preoperative concurrent chemoradiotherapy
description: The patients will receive radiotherapy in the total amount of 50Gy(25 fractions) preoperatively,concurrently combined with chemotherapy,which consist of oxaliplatin 40mg/m2 administrated on days 1,8,15,22,29 and S-1® 30mg/m2 twice per day on days 1 to 5 per week.
arm group label: CCRT group
other name: CCRT
other name: Eloxatin®
other name: S-1®
intervention type: Procedure
intervention name: Radical D2 total gastrectomy
description: Within 5-6 weeks after the completion of neoadjuvant therapy,the patients in CCRT group will receive the radical total gastrectomy with D2 lymphadenectomy,and patients in the CT group will receive the surgery right after randomization.
arm group label: CCRT group
arm group label: CT group
intervention type: Drug
intervention name: Adjuvant chemotherapy
description: Within 2 months after surgery,the patients will receive chemotherapy for 6 to 8 cycles ,consist of oxaliplatin 130mg/m2 administrated on day1 and S-1® 40-60mg twice per day on days 1 to 14 per 3 weeks.The S-1® dosage depends on the patient BSA(BSA<1.25m2 40mg,1.25 m2≤BSA≤1.5 m2 50mg ,BSA>1.5 m2 60mg). Patients in the CCRT group will receive 6 cycles of chemotherapy and patients in the CT group will receive 8 cycles of chemotherapy.
arm group label: CCRT group
arm group label: CT group
other name: Eloxatin®
other name: S-1®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jiafu Ji, M.D.
role: Principal Investigator
affiliation: Peking University Cancer Hospital & Institute
last name: Jiafu Ji, M.D.
email: jiafuj@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Jiafu Ji
investigator title: President of Beijing Cancer Hospital,Director of Key Laboratory of Carcinogenesis and Translational Research(Gastric Cancer Laboratory)
mesh term: Adenocarcinoma
mesh term: Esophageal Neoplasms
mesh term: Oxaliplatin