<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/NCT02188615</url>
  </required_header>
  <id_info>
    <org_study_id>BZhang</org_study_id>
    <secondary_id>2011C13039-2</secondary_id>
    <nct_id>NCT02188615</nct_id>
  </id_info>
  <brief_title>Study of Neo-adjuvant Chemoradiotherapy Followed by Minimally Invasive Esophagectomy for Squamous Cell Esophageal Cancer</brief_title>
  <acronym>NACRFMIE</acronym>
  <official_title>A Single Institution Prospective Randomized Controlled Clinical Trial of Neo-adjuvant Chemoradiotherapy Followed by Mckeown Minimally Invasive Esophagectomy (MIE) Versus Mckeown MIE for Locally Advanced Squamous Cell Esophageal Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chengchu Zhu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Taizhou Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is to compare neo-adjuvant chemoradiotherapy followed by Mckeown&#xD;
      Minimally Invasive Esophagectomy (MIE) Versus Mckeown MIE, pure radical chemoradiotherapy in&#xD;
      terms of the overall survival time (OS) in patients with Stage IIB or III squamous cell&#xD;
      esophageal carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Esophageal cancer is one of the most difficult malignancies to cure. Surgical resection&#xD;
      remains the primary treatment for localized esophageal cancer. It increases the chances of&#xD;
      cure and alleviates the symptoms of dysphagia compared with nonoperative methods. Advances in&#xD;
      surgical techniques and equipments have made minimally invasive esophagectomy (MIE) more&#xD;
      popular and wider application since 1990s. During the past two decades, MIE has progressively&#xD;
      been accepted as an alternative treatment for esophageal cancer around the world. The&#xD;
      prognosis has some improvement on account of these significant advances in surgical&#xD;
      techniques and perioperative management, But the prognosis of patients with locally advanced&#xD;
      esophageal cancer remains rather poor. As a result of surgery alone, the 5-year survival rate&#xD;
      of about 25% has not changed significantly in several decades.&#xD;
&#xD;
      Preoperative chemoradiotherapy followed by surgery seems to hopefully improve the survival of&#xD;
      EC. Nevertheless, the results of different studies were inconsistent. Recently, the CROSS&#xD;
      trial has demonstrated that preoperative chemoradiotherapy can significantly increased the&#xD;
      overall survival of patients with EC compared with surgery alone. It should be noticed that&#xD;
      only 84 cases(23%) of ESCC were enrolled in this trial with potential minimal follow-up of 2&#xD;
      years, which may be not perfect to evaluate the effect of this combined therapy for this&#xD;
      tumor type.&#xD;
&#xD;
      Based on our preliminary study, we have demonstrated the validity and safety of vinorelbine&#xD;
      and cisplatin-based neoadjuvant chemoradiotherapy. Then we are to carry out a clinical trial&#xD;
      to investigate the effect of this multidisciplinary therapy, by comparing neo-adjuvant&#xD;
      chemoradiotherapy followed by Mckeown MIE versus Mckeown MIE, pure radical chemoradiotherapy&#xD;
      in terms of the overall survival time (OS) in patients with Stage IIB or III squamous cell&#xD;
      esophageal carcinoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2011</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2015</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival rate</measure>
    <time_frame>1 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease free survival</measure>
    <time_frame>5years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival rate</measure>
    <time_frame>3years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival rate</measure>
    <time_frame>5years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>the opportunity of MIE after neo-adjuvant chemoradiotherapy</measure>
    <time_frame>4 weeks after completion of radiotherapy</time_frame>
    <description>Criteria:Response Evaluation Criteria in Solid Tumors，RECIST</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects of neo-adjuvant chemoradiotherapy</measure>
    <time_frame>2 weeks after completion of radiotherapy</time_frame>
    <description>Evaluate the toxicities of neo-adjuvant chemoradiotherapy,according to National Cancer Institute Common Terminology Criteria for Adverse Event,Version 3.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of surgery</measure>
    <time_frame>Intraoperative</time_frame>
    <description>The time between the start of surgery until the end of surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of bleeding</measure>
    <time_frame>Intraoperative</time_frame>
    <description>The amount of bleeding during surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of lymph nodes retrieved</measure>
    <time_frame>Intraoperative</time_frame>
    <description>The total number of lymph nodes obtained including cervix area, mediastinum area , abdominal area</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days of postoperative stay</measure>
    <time_frame>The duration of hospital stay after surgery, an expected average of 12 days</time_frame>
    <description>Participants will be followed for the duration of hospital stay after surgery, an expected average of 12 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Operative Complication</measure>
    <time_frame>30 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality of perioperation</measure>
    <time_frame>30 days after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Squamous Cell Esophageal Carcinoma</condition>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Radical Chemoradiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>only Radical Chemoradiotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mckeown MIE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>only Mckeown MIE</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE</intervention_name>
    <description>Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE</description>
    <arm_group_label>experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>only Radical Chemoradiotherapy</description>
    <arm_group_label>Radical Chemoradiotherapy</arm_group_label>
    <other_name>vinorelbine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mckeown MIE</intervention_name>
    <description>only Mckeown MIE using thoracoscopy and laparoscopy</description>
    <arm_group_label>Mckeown MIE</arm_group_label>
    <other_name>Thoracoscopy</other_name>
    <other_name>Laparoscopy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage IIB or&#xD;
             III, which is potentially resectable.&#xD;
&#xD;
          2. Patients must not have received any prior anticancer therapy.&#xD;
&#xD;
          3. More than 6 months of expected survival.&#xD;
&#xD;
          4. Age ranges from 18 to 70 years.&#xD;
&#xD;
          5. Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets&#xD;
             ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.&#xD;
&#xD;
          6. Karnofsky performance status (KPS) of 90 or more.&#xD;
&#xD;
          7. Signed informed consent document on file.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients are diagnosed or suspected to be allergic to cisplatin or vinorelbine.&#xD;
&#xD;
          2. Patients with concomitant hemorrhagic disease.&#xD;
&#xD;
          3. Pregnant or breast feeding.&#xD;
&#xD;
          4. Inability to use gastric conduit after esophagectomy because of a prior surgery.&#xD;
&#xD;
          5. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.&#xD;
&#xD;
          6. Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the&#xD;
             cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cheng chu Zhu, professor</last_name>
    <role>Study Chair</role>
    <affiliation>Taizhou Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bao fu Chen, professor</last_name>
    <role>Study Director</role>
    <affiliation>Taizhou Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cheng chu Zhu, professor</last_name>
    <phone>86-576-85199876</phone>
    <email>zhucc669266@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>min Kong, master</last_name>
    <phone>86-576-85199101</phone>
    <email>kongm@enzemed.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Thaizhou Hospital</name>
      <address>
        <city>Linhai</city>
        <state>Zhejiang</state>
        <zip>317000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cheng chu Zhu, professor</last_name>
      <phone>+86-576-85199876</phone>
      <email>zhucc669266@163.com</email>
    </contact>
    <investigator>
      <last_name>Bao fu Chen, professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>July 9, 2014</last_update_submitted>
  <last_update_submitted_qc>July 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Taizhou Hospital</investigator_affiliation>
    <investigator_full_name>Chengchu Zhu</investigator_full_name>
    <investigator_title>Division Director</investigator_title>
  </responsible_party>
  <keyword>Squamous Cell Esophageal Carcinoma</keyword>
  <keyword>minimally invasive esophagectomy</keyword>
  <keyword>laparoscopy</keyword>
  <keyword>thoracoscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</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>Vinorelbine</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/NCT02188615
org study id: BZhang
secondary id: 2011C13039-2
nct id: NCT02188615
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The primary objective is to compare neo-adjuvant chemoradiotherapy followed by Mckeown
      Minimally Invasive Esophagectomy (MIE) Versus Mckeown MIE, pure radical chemoradiotherapy in
      terms of the overall survival time (OS) in patients with Stage IIB or III squamous cell
      esophageal carcinoma.
Esophageal cancer is one of the most difficult malignancies to cure. Surgical resection
      remains the primary treatment for localized esophageal cancer. It increases the chances of
      cure and alleviates the symptoms of dysphagia compared with nonoperative methods. Advances in
      surgical techniques and equipments have made minimally invasive esophagectomy (MIE) more
      popular and wider application since 1990s. During the past two decades, MIE has progressively
      been accepted as an alternative treatment for esophageal cancer around the world. The
      prognosis has some improvement on account of these significant advances in surgical
      techniques and perioperative management, But the prognosis of patients with locally advanced
      esophageal cancer remains rather poor. As a result of surgery alone, the 5-year survival rate
      of about 25% has not changed significantly in several decades.

      Preoperative chemoradiotherapy followed by surgery seems to hopefully improve the survival of
      EC. Nevertheless, the results of different studies were inconsistent. Recently, the CROSS
      trial has demonstrated that preoperative chemoradiotherapy can significantly increased the
      overall survival of patients with EC compared with surgery alone. It should be noticed that
      only 84 cases(23%) of ESCC were enrolled in this trial with potential minimal follow-up of 2
      years, which may be not perfect to evaluate the effect of this combined therapy for this
      tumor type.

      Based on our preliminary study, we have demonstrated the validity and safety of vinorelbine
      and cisplatin-based neoadjuvant chemoradiotherapy. Then we are to carry out a clinical trial
      to investigate the effect of this multidisciplinary therapy, by comparing neo-adjuvant
      chemoradiotherapy followed by Mckeown MIE versus Mckeown MIE, pure radical chemoradiotherapy
      in terms of the overall survival time (OS) in patients with Stage IIB or III squamous cell
      esophageal carcinoma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Overall survival rate
time frame: 1 years
measure: Disease free survival
time frame: 5years
measure: Overall survival rate
time frame: 3years
measure: Overall survival rate
time frame: 5years
measure: the opportunity of MIE after neo-adjuvant chemoradiotherapy
time frame: 4 weeks after completion of radiotherapy
description: Criteria:Response Evaluation Criteria in Solid Tumors，RECIST
measure: Side effects of neo-adjuvant chemoradiotherapy
time frame: 2 weeks after completion of radiotherapy
description: Evaluate the toxicities of neo-adjuvant chemoradiotherapy,according to National Cancer Institute Common Terminology Criteria for Adverse Event,Version 3.0
measure: Duration of surgery
time frame: Intraoperative
description: The time between the start of surgery until the end of surgery
measure: Quantity of bleeding
time frame: Intraoperative
description: The amount of bleeding during surgery
measure: number of lymph nodes retrieved
time frame: Intraoperative
description: The total number of lymph nodes obtained including cervix area, mediastinum area , abdominal area
measure: Days of postoperative stay
time frame: The duration of hospital stay after surgery, an expected average of 12 days
description: Participants will be followed for the duration of hospital stay after surgery, an expected average of 12 days
measure: Rate of Operative Complication
time frame: 30 days after surgery
measure: Mortality of perioperation
time frame: 30 days after surgery
arm group label: experimental group
arm group type: Experimental
description: Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE
arm group label: Radical Chemoradiotherapy
arm group type: Active Comparator
description: only Radical Chemoradiotherapy
arm group label: Mckeown MIE
arm group type: Active Comparator
description: only Mckeown MIE
intervention type: Procedure
intervention name: Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE
description: Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE
arm group label: experimental group
intervention type: Drug
intervention name: Cisplatin
description: only Radical Chemoradiotherapy
arm group label: Radical Chemoradiotherapy
other name: vinorelbine
intervention type: Device
intervention name: Mckeown MIE
description: only Mckeown MIE using thoracoscopy and laparoscopy
arm group label: Mckeown MIE
other name: Thoracoscopy
other name: Laparoscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Cheng chu Zhu, professor
role: Study Chair
affiliation: Taizhou Hospital
last name: Bao fu Chen, professor
role: Study Director
affiliation: Taizhou Hospital
last name: Cheng chu Zhu, professor
phone: 86-576-85199876
email: zhucc669266@163.com
last name: min Kong, master
phone: 86-576-85199101
email: kongm@enzemed.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Taizhou Hospital
investigator full name: Chengchu Zhu
investigator title: Division Director
mesh term: Carcinoma
mesh term: Esophageal Neoplasms
mesh term: Vinorelbine