xml: <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/NCT06012214</url>
    </required_header>
    <id_info>
      <org_study_id>RAMIE-2</org_study_id>
      <nct_id>NCT06012214</nct_id>
    </id_info>
    <brief_title>RAE Versus MIE in Patients With Esophageal Cancer After Neoadjuvant Therapy</brief_title>
    <official_title>Robot-assisted Versus Conventional Minimally Invasive Esophagectomy for Locally Advanced Esophageal Squamous Cell Carcinoma After Neoadjuvant Therapy: a Prospective Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Chest Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Chest Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a prospectively randomized controlled trial to compare RAMIE and MIE in the treatment&#xD;
        for locally advanced ESCC after neoadjuvant therapy. According to previous studies, long-term&#xD;
        survival after RAMIE seemed to be at least comparable to MIE or open esophagectomy.&#xD;
        Therefore, the RAMIE-2 study was designed as a non-inferiority trial, which was based on the&#xD;
        hypothesis that the 5-year overall survival of patients who received RAMIE is uncompromised&#xD;
        to MIE. To achieve the primary endpoint, 260 cases will be recruited in our hospital. Based&#xD;
        on the volume of esophagectomy (1000 cases/year) and the proportion of patients with&#xD;
        neoadjuvant therapy (50%) in our institution, approximately 10 patients will be enrolled for&#xD;
        each group per month for this trial. The study will be performed in accordance with the&#xD;
        principles of the Declaration of Helsinki and Good Clinical Practice Guidelines. Written&#xD;
        informed consent will be obtained from each participant. The flow chart of this trial is also&#xD;
        presented.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Neoadjuvant therapy followed by radical resection is the recommended treatment for locally&#xD;
        advanced esophageal cancer, which could achieve a better R0 resection and overall survival.&#xD;
        With the development of multidisciplinary treatment of esophageal cancer, especially the&#xD;
        emerging concept of &quot;watch and wait&quot;, surgery may only be a new era of salvage treatment for&#xD;
        patients with poor response to neoadjuvant or recurrence after definitive treatment in the&#xD;
        future. At that time, the technical advantage of RAMIE should be even more valuable. Early&#xD;
        results of the RAMIE trial (conducted by our group)15, has demonstrated that RAMIE can&#xD;
        achieve shorter operative time as well as better lymph node dissection in patients who&#xD;
        received neoadjuvant therapy, compared to conventional MIE. In addition, this benefit was&#xD;
        more obviously observed in lymph nodes along the bilateral recurrent laryngeal nerves, which&#xD;
        were considered as the most challenging steps.&#xD;
  &#xD;
        Therefore, we put forward a hypothesis: whether the robot's superior human-surgical interface&#xD;
        is beneficial to achieve better surgical and oncological results in patients with locally&#xD;
        advanced ESCC after neoadjuvant therapy. Based on the results of RAMIE trial, the present&#xD;
        RAMIE-2 study is trying to answer such a question.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">December 31, 2028</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2028</primary_completion_date>
    <phase>N/A</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>overall survival</measure>
      <time_frame>up to 5 years</time_frame>
      <description>defined as the time from the date of surgery to the day of death or to the last follow-up.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>disease-free survival</measure>
      <time_frame>up to 5 year</time_frame>
      <description>defined as the time from the date of surgery to the day of tumor recurrence, tumor progression or death assessed up to 5 years</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>oncologic results</measure>
      <time_frame>4 weeks</time_frame>
      <description>number of lymph nodes dissection, R0 resection rate</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Surgical Procedure, Unspecified</condition>
    <arm_group>
      <arm_group_label>Robot-assisted minimally invasive esophagectomy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will received neoadjuvant therapy followed by robot-assisted minimally invasive esophagectomy within 8 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Thoraco-laparoscopic minimally invasive esophagectomy</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants will received neoadjuvant therapy followed by thoraco-laparoscopic minimally invasive esophagectomy within 8 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>ROBOTIC-ASSISTED ESOPHAGECTOMY</intervention_name>
      <description>Comparison between robotic and conventional minimally invasive esophagectomy</description>
      <arm_group_label>Robot-assisted minimally invasive esophagectomy</arm_group_label>
      <arm_group_label>Thoraco-laparoscopic minimally invasive esophagectomy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ranges from 18 to 75 years;&#xD;
  &#xD;
            2. European Clinical Oncology Group Performance Status (ECOG PS) 0-2;&#xD;
  &#xD;
            3. Histological subtype of esophageal squamous cell carcinoma;&#xD;
  &#xD;
            4. Primary tumors are located at the intrathoracic esophagus;&#xD;
  &#xD;
            5. Pre-treatment stage as cT1b-4aN1-3M0, cT3N0M0 (AJCC/UICC 8th Edition);&#xD;
  &#xD;
            6. With neoadjuvant chemoradiotherapy, chemotherapy and immunotherapy;&#xD;
  &#xD;
            7. Without any anticancer therapy for other malignant diseases;&#xD;
  &#xD;
            8. Written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Cervical esophageal cancer and carcinoma of gastro-esophageal junction;&#xD;
  &#xD;
            2. Patients with unresectable or metastatic esophageal cancer;&#xD;
  &#xD;
            3. Histological subtype of esophageal non-squamous cell carcinoma;&#xD;
  &#xD;
            4. History of previous thoracic surgery;&#xD;
  &#xD;
            5. Patients with other malignant tumor (previous or current);&#xD;
  &#xD;
            6. Participation in another clinical trial during this study.&#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>Zhigang Li, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shanghai Chest Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yang Yang, Dr.</last_name>
      <phone>86 21-22200000*2116</phone>
      <email>yangyang@shsmu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Shanghai Chest Hospital, Shanghai Jiao Tong University</name>
        <address>
          <city>Shanghai</city>
          <zip>SH 21</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Shanghai Chest Hospital</investigator_affiliation>
      <investigator_full_name>Zhigang Li</investigator_full_name>
      <investigator_title>Prof.</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06012214
  org study id: RAMIE-2
  nct id: NCT06012214
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a prospectively randomized controlled trial to compare RAMIE and MIE in the treatment
        for locally advanced ESCC after neoadjuvant therapy. According to previous studies, long-term
        survival after RAMIE seemed to be at least comparable to MIE or open esophagectomy.
        Therefore, the RAMIE-2 study was designed as a non-inferiority trial, which was based on the
        hypothesis that the 5-year overall survival of patients who received RAMIE is uncompromised
        to MIE. To achieve the primary endpoint, 260 cases will be recruited in our hospital. Based
        on the volume of esophagectomy (1000 cases/year) and the proportion of patients with
        neoadjuvant therapy (50%) in our institution, approximately 10 patients will be enrolled for
        each group per month for this trial. The study will be performed in accordance with the
        principles of the Declaration of Helsinki and Good Clinical Practice Guidelines. Written
        informed consent will be obtained from each participant. The flow chart of this trial is also
        presented.
  Neoadjuvant therapy followed by radical resection is the recommended treatment for locally
        advanced esophageal cancer, which could achieve a better R0 resection and overall survival.
        With the development of multidisciplinary treatment of esophageal cancer, especially the
        emerging concept of "watch and wait", surgery may only be a new era of salvage treatment for
        patients with poor response to neoadjuvant or recurrence after definitive treatment in the
        future. At that time, the technical advantage of RAMIE should be even more valuable. Early
        results of the RAMIE trial (conducted by our group)15, has demonstrated that RAMIE can
        achieve shorter operative time as well as better lymph node dissection in patients who
        received neoadjuvant therapy, compared to conventional MIE. In addition, this benefit was
        more obviously observed in lymph nodes along the bilateral recurrent laryngeal nerves, which
        were considered as the most challenging steps.
  
        Therefore, we put forward a hypothesis: whether the robot's superior human-surgical interface
        is beneficial to achieve better surgical and oncological results in patients with locally
        advanced ESCC after neoadjuvant therapy. Based on the results of RAMIE trial, the present
        RAMIE-2 study is trying to answer such a question.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: overall survival
  time frame: up to 5 years
  description: defined as the time from the date of surgery to the day of death or to the last follow-up.
  measure: disease-free survival
  time frame: up to 5 year
  description: defined as the time from the date of surgery to the day of tumor recurrence, tumor progression or death assessed up to 5 years
  measure: oncologic results
  time frame: 4 weeks
  description: number of lymph nodes dissection, R0 resection rate
  arm group label: Robot-assisted minimally invasive esophagectomy
  arm group type: Experimental
  description: Participants will received neoadjuvant therapy followed by robot-assisted minimally invasive esophagectomy within 8 weeks.
  arm group label: Thoraco-laparoscopic minimally invasive esophagectomy
  arm group type: Placebo Comparator
  description: Participants will received neoadjuvant therapy followed by thoraco-laparoscopic minimally invasive esophagectomy within 8 weeks.
  intervention type: Procedure
  intervention name: ROBOTIC-ASSISTED ESOPHAGECTOMY
  description: Comparison between robotic and conventional minimally invasive esophagectomy
  arm group label: Robot-assisted minimally invasive esophagectomy
  arm group label: Thoraco-laparoscopic minimally invasive esophagectomy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Zhigang Li, Dr.
  role: Principal Investigator
  affiliation: Shanghai Chest Hospital
  last name: Yang Yang, Dr.
  phone: 86 21-22200000*2116
  email: yangyang@shsmu.edu.cn
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Shanghai Chest Hospital
  investigator full name: Zhigang Li
  investigator title: Prof.
  sharing ipd: No