<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/NCT03001596</url>
  </required_header>
  <id_info>
    <org_study_id>CMISG1701</org_study_id>
    <nct_id>NCT03001596</nct_id>
  </id_info>
  <brief_title>Comparison Between NCRT and NCT Followed by MIE for Treatment of Locally Advanced Resectable ESCC</brief_title>
  <acronym>ESCCNCRTvNCT</acronym>
  <official_title>Neoadjuvant Chemoradiotherapy VS. Neoadjuvant Chemotherapy Followed by Minimally Invasive Esophagectomy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma（cT3-4aN0-1M0):A Multi-center Prospective Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fujian Medical University Union Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin Medical University Cancer Institute and Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Chest Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Changzhi Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Wenzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan Union Hospital, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University Cancer Hospital and Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the outcomes of neoadjuvant chemoradiotherapy versus&#xD;
      neoadjuvant chemotherapy followed by minimally invasive esophagectomy on patients with&#xD;
      locally advanced resectable esophageal squamous cell carcinoma(cT3-4aN0-1M0).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is a prospective randomized phase III clinical trial sponsored by Shanghai Zhongshan&#xD;
      Hospital with other eight hospitals in China participating in. 264 patients with locally&#xD;
      advanced resectable esophageal squamous cell carcinoma(cT3-4aN0-1M0) are recruited and&#xD;
      randomly assigned into the neoadjuvant chemoradiotherapy group (NCRT group) and the&#xD;
      neoadjuvant chemotherapy group (NCT group) according to the proportion of 1:1.The&#xD;
      safety,efficacy of protocols and prognosis of patients are compared between the two regimens.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">August 2020</completion_date>
  <primary_completion_date type="Actual">February 2019</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(OS)</measure>
    <time_frame>Up to the date of death of any causes since the date of randomization, up to 36 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival(PFS)</measure>
    <time_frame>Up to the date of disease recurrence since the date of randomization, up to 36 months</time_frame>
    <description>Disease recurrence is defined as locoregional (esophageal bed or anastomotic or regional lymph nodes) or metastatic (supraclavicular lymph nodes or distant organs).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pathological response rate(pCR)</measure>
    <time_frame>Up to the date of pathological reports obtained since the date of randomization, up to 12 months</time_frame>
    <description>The resected specimen following neo-adjuvant treatment are assessed by using standardised work up of the resection specimen in the pathology department and standardised histological criteria for tumour regression grading. The degree of histomorphologic regression is clarified into four categories as follows: grade 1, no evidence of vital residual tumor cells (pathological complete response); grade 2, less than 10% vital residual tumor cells; grade 3, 10 to 50%; and grade 4, more than 50%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>R0 resection rate</measure>
    <time_frame>Up to the date of pathological reports obtained since the date of randomization, up to 12 months</time_frame>
    <description>No vital tumor is presented at the proximal, distal, or circumferential resection margin, it is considered to be R0 resection. If a vital tumor is shown at 1 mm or less from the proximal, distal, or circumferential resection margin, it is considered to be microscopically positive (R1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive lymph nodes' number</measure>
    <time_frame>Up to the date of pathological reports obtained since the date of randomization, up to 12 months</time_frame>
    <description>According to pathological reports, record the number of positive lymph nodes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment related complications</measure>
    <time_frame>Up to 1 month after surgery since the data of randomization, up to 13 months</time_frame>
    <description>Number and severity of adverse events that are related to treatment of each patients, and hospital readmission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life(QOL)</measure>
    <time_frame>Up to the end of follow-up since the data of surgery, up to 36 months</time_frame>
    <description>QOL is respectively evaluated at randomization and 1 month, 3 month, 6 month and yearly after surgery among patients by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C30) and EORTC QLQ-OES18</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence-free survival (RFS)</measure>
    <time_frame>Up to the date of disease recurrence since the date of surgery, up to 36 months</time_frame>
    <description>RFS is defined in resected patients who achieved an R0 or R1 resection as the time interval from surgery to the date of first recurrence (local, regional or distant) or death, whichever comes first.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">264</enrollment>
  <condition>Esophageal Squamous Cell Carcinoma Stage cT3-4aN0-1M0</condition>
  <arm_group>
    <arm_group_label>Neoadjuvant chemoradiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neoadjuvant chemoradiotherapy (NCRT) is performed followed by minimally invasive esophagectomy in enrolled patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neoadjuvant chemotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Neoadjuvant chemotherapy (NCT) is performed followed by minimally invasive esophagectomy in enrolled patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Neoadjuvant Chemoradiotherapy</intervention_name>
    <description>Before surgery, patients in this group receive neoadjuvant chemoradiotherapy. A total dose of 40 Gy is delivered in 20 fractions (5 fractions per week) for 4 weeks. Chemotherapy is delivered concomitantly and composed of four cycles of paclitaxel 50mg per square meter of body-surface area and cisplatin 25mg per square meter of body-surface area weekly at the intervals of radiotherapy. After neoadjuvant therapy of 4-8 weeks, minimally invasive esophagectomy is performed.</description>
    <arm_group_label>Neoadjuvant chemoradiotherapy</arm_group_label>
    <other_name>Preoperative Chemoradiotherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Neoadjuvant Chemotherapy</intervention_name>
    <description>Before surgery, patients in this group receive neoadjuvant chemotherapy. Chemotherapy is delivered and composed of two cycles of paclitaxel 135mg per square meter of body-surface area and cisplatin 75mg per square meter of body-surface area every 4 weeks. After neoadjuvant therapy of 4-8 weeks, minimally invasive esophagectomy is performed.</description>
    <arm_group_label>Neoadjuvant chemotherapy</arm_group_label>
    <other_name>Preoperative Chemotherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Minimally Invasive Esophagectomy</intervention_name>
    <description>After neoadjuvant therapy, patients in groups receive minimally invasive esophagectomy</description>
    <arm_group_label>Neoadjuvant chemoradiotherapy</arm_group_label>
    <arm_group_label>Neoadjuvant chemotherapy</arm_group_label>
    <other_name>MIE</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically-confirmed squamous cell carcinoma of the esophagus;&#xD;
&#xD;
          2. Tumors of the esophagus are located in the thoracic cavity;&#xD;
&#xD;
          3. Pre-treatment stage as cT3-4aN0-1M0 (AJCC/UICC 7th Edition) (In case of stage cT4a,&#xD;
             curative resectability has to be explicitly verified by the local surgical&#xD;
             investigator prior to randomization).&#xD;
&#xD;
          4. Age is between 18 years and 75 years,&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;&#xD;
&#xD;
          6. Adequate cardiac function. All patients should perform ECG, and those with a cardiac&#xD;
             history or ECG abnormality should perform echocardiography with the left ventricular&#xD;
             ejection fraction &gt; 50 %.&#xD;
&#xD;
          7. Adequate respiratory function with FEV1≥1.2L, FEV1%≥50% and DLCO≥50% shown in&#xD;
             pulmonary function tests.&#xD;
&#xD;
          8. Adequate bone marrow function (White Blood Cells &gt;4x10^9 /L; Neutrophil &gt;2.0×10^9 /L;&#xD;
             Hemoglobin &gt; 90 g/L; platelets&gt;100x10^9 /L);&#xD;
&#xD;
          9. Adequate liver function (Total bilirubin &lt;1.5x Upper Level of Normal (ULN); Aspartate&#xD;
             transaminase(AST) and Alanine transaminase (ALT) &lt;1.5x ULN);&#xD;
&#xD;
         10. Adequate renal function (Glomerular filtration rate (CCr) &gt;60 ml/min; serum creatinine&#xD;
             (SCr) ≤120 µmol/L)；&#xD;
&#xD;
         11. The patient has provided written informed consent and is able to understand and comply&#xD;
             with the study;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with non-squamous cell carcinoma histology;&#xD;
&#xD;
          2. Patients with advanced inoperable or metastatic esophageal cancer;&#xD;
&#xD;
          3. Pre-treatment stage as cT1-2N0-1M0 (AJCC/UICC 7th Edition);&#xD;
&#xD;
          4. Pre-treatment stage as cN2-3 or cT4b(non-curatively-resectable verified by the local&#xD;
             surgical investigator, AJCC/UICC 7th Edition);&#xD;
&#xD;
          5. Patients with another previous or current malignant disease which is likely to&#xD;
             interfere with treatment or the assessment of response in the judgement of the local&#xD;
             surgical investigator.&#xD;
&#xD;
          6. Any patient with a significant medical condition which is thought unlikely to tolerate&#xD;
             the therapies. Such as cardiac disease (e.g. symptomatic coronary artery disease or&#xD;
             myocardial infarction within last 12 months), clinically-significant lung disease,&#xD;
             clinically-significant bone marrow, liver, renal function disorder;&#xD;
&#xD;
          7. Pregnant or lactating women and fertile women who will not be using contraception&#xD;
             during the trial;&#xD;
&#xD;
          8. Allergy to any drugs;&#xD;
&#xD;
          9. Participation in another intervention clinical trial with interference to the&#xD;
             chemotherapeutic or chemoradiotherapeutic intervention during this study or during the&#xD;
             last 30 days prior to informed consent;&#xD;
&#xD;
         10. Expected lack of compliance with the protocol.&#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>Lijie Tan, MD</last_name>
    <role>Study Director</role>
    <affiliation>Shanghai Zhongshan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.jnccn.org/content/13/2/229.long</url>
    <description>NCCN</description>
  </link>
  <link>
    <url>http://ovidsp.tx.ovid.com/sp-3.23.1b/ovidweb.cgi?QS2=434f4e1a73d37e8c69b2b0e6f081d5f3b049d714ef71fa504f02ec2bc6a9693d94f7b1018730c6aa02e3a91bed86f2d9c107b57c423c73c4b90c95cf2194fb817fcdff85af6c36eef51b7c6a4795ce6841bd591836b6c019cd09e67e7be0641d8f8be033005c89d9b951cdef6ab2b21d996f8fda4b3c5a6ec440b7851618c1e6df590117d4374a4c8fd0563034067fe85cd9b29ecdcaaf98468c6bb2de555e034c792b370a38d8e9b3b5bc2dda4b4733866dbc8c84c29c4fbde9ad3cab0771078e507d884d3b0bf2e3e80fbd2d2c06aac17c0bbb2712743af2ef29512bf6faeb4578c925eea58f9a4ccd74b2389b41a15e3c0ed803f92fac0431e7a0d34db087952f25496e3c0543333c51e852bbcc425b338d99f9bccdb1c6fa45482a87150c1d4d74b2715bd079ee267afe46233316b0c925d011c779cd6bc1d289f75f315284c689d7b3fde54c16c233d2a0c6b1dc96968ea8baa05f48c5f81173c28c9a6b12668d38b85f756de32e9f67db7262a4fbacb2cd417b272398b17d8aa26e3213</url>
    <description>Wolters kluwer</description>
  </link>
  <link>
    <url>http://journals.lww.com/annalsofsurgery/pages/articleviewer.aspx?year=2003&amp;issue=10000&amp;article=00004&amp;type=abstract</url>
    <description>Wolters kluwer</description>
  </link>
  <link>
    <url>http://link.springer.com/article/10.1007%2Fs00464-008-9799-x</url>
    <description>Springer</description>
  </link>
  <link>
    <url>http://online.liebertpub.com/doi/abs/10.1089/lap.2014.0118</url>
    <description>Atypon</description>
  </link>
  <link>
    <url>http://link.springer.com/article/10.1007%2Fs00464-014-3753-x</url>
    <description>Springer</description>
  </link>
  <link>
    <url>http://jtd.amegroups.com/article/view/2243/3085</url>
    <description>AME</description>
  </link>
  <link>
    <url>http://icvts.oxfordjournals.org/content/19/2/263.long</url>
    <description>Oxford University Press</description>
  </link>
  <link>
    <url>http://link.springer.com/article/10.1007%2Fs11605-012-1824-7</url>
    <description>Springer</description>
  </link>
  <link>
    <url>http://link.springer.com/article/10.1007%2Fs11136-010-9742-1</url>
    <description>Springer</description>
  </link>
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  </results_reference>
  <results_reference>
    <citation>Warner S, Chang YH, Paripati H, Ross H, Ashman J, Harold K, Day R, Stucky CC, Rule W, Jaroszewski D. Outcomes of minimally invasive esophagectomy in esophageal cancer after neoadjuvant chemoradiotherapy. Ann Thorac Surg. 2014 Feb;97(2):439-45. doi: 10.1016/j.athoracsur.2013.09.042. Epub 2013 Nov 20.</citation>
    <PMID>24266955</PMID>
  </results_reference>
  <results_reference>
    <citation>Burmeister BH, Thomas JM, Burmeister EA, Walpole ET, Harvey JA, Thomson DB, Barbour AP, Gotley DC, Smithers BM. Is concurrent radiation therapy required in patients receiving preoperative chemotherapy for adenocarcinoma of the oesophagus? A randomised phase II trial. Eur J Cancer. 2011 Feb;47(3):354-60. doi: 10.1016/j.ejca.2010.09.009.</citation>
    <PMID>21084184</PMID>
  </results_reference>
  <results_reference>
    <citation>Li J, Shen Y, Tan L, Feng M, Wang H, Xi Y, Wang Q. Is minimally invasive esophagectomy beneficial to elderly patients with esophageal cancer? Surg Endosc. 2015 Apr;29(4):925-30. doi: 10.1007/s00464-014-3753-x. Epub 2014 Sep 24.</citation>
    <PMID>25249141</PMID>
  </results_reference>
  <results_reference>
    <citation>Shen Y, Feng M, Tan L, Wang H, Li J, Xi Y, Wang Q. Thoracoscopic esophagectomy in prone versus decubitus position: ergonomic evaluation from a randomized and controlled study. Ann Thorac Surg. 2014 Sep;98(3):1072-8. doi: 10.1016/j.athoracsur.2014.04.107. Epub 2014 Jul 16.</citation>
    <PMID>25038015</PMID>
  </results_reference>
  <results_reference>
    <citation>Li J, Shen Y, Tan L, Feng M, Wang H, Xi Y, Leng Y, Wang Q. Cervical triangulating stapled anastomosis: technique and initial experience. J Thorac Dis. 2014 May;6 Suppl 3(Suppl 3):S350-4. doi: 10.3978/j.issn.2072-1439.2014.02.06.</citation>
    <PMID>24876941</PMID>
  </results_reference>
  <results_reference>
    <citation>Shen Y, Wang H, Feng M, Tan L, Wang Q. The effect of narrowed gastric conduits on anastomotic leakage following minimally invasive oesophagectomy. Interact Cardiovasc Thorac Surg. 2014 Aug;19(2):263-8. doi: 10.1093/icvts/ivu151. Epub 2014 May 20.</citation>
    <PMID>24847029</PMID>
  </results_reference>
  <results_reference>
    <citation>Shen Y, Feng M, Khan MA, Wang H, Tan L, Wang Q. A simple method minimizes chylothorax after minimally invasive esophagectomy. J Am Coll Surg. 2014 Jan;218(1):108-12. doi: 10.1016/j.jamcollsurg.2013.09.014. Epub 2013 Nov 7.</citation>
    <PMID>24211053</PMID>
  </results_reference>
  <results_reference>
    <citation>Wang H, Tan L, Feng M, Zhang Y, Wang Q. Comparison of the short-term health-related quality of life in patients with esophageal cancer with different routes of gastric tube reconstruction after minimally invasive esophagectomy. Qual Life Res. 2011 Mar;20(2):179-89. doi: 10.1007/s11136-010-9742-1. Epub 2010 Sep 21.</citation>
    <PMID>20857337</PMID>
  </results_reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 17, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>September 7, 2020</last_update_submitted>
  <last_update_submitted_qc>September 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neoadjuvant Chemoradiotherapy</keyword>
  <keyword>Neoadjuvant Chemotherapy</keyword>
  <keyword>Minimally Invasive Esophagectomy</keyword>
  <keyword>Esophageal Squamous Cell Carcinoma（cT3-4aN0-1M0）</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Esophageal Squamous Cell Carcinoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03001596
org study id: CMISG1701
nct id: NCT03001596
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the outcomes of neoadjuvant chemoradiotherapy versus
      neoadjuvant chemotherapy followed by minimally invasive esophagectomy on patients with
      locally advanced resectable esophageal squamous cell carcinoma(cT3-4aN0-1M0).
It is a prospective randomized phase III clinical trial sponsored by Shanghai Zhongshan
      Hospital with other eight hospitals in China participating in. 264 patients with locally
      advanced resectable esophageal squamous cell carcinoma(cT3-4aN0-1M0) are recruited and
      randomly assigned into the neoadjuvant chemoradiotherapy group (NCRT group) and the
      neoadjuvant chemotherapy group (NCT group) according to the proportion of 1:1.The
      safety,efficacy of protocols and prognosis of patients are compared between the two regimens.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival(OS)
time frame: Up to the date of death of any causes since the date of randomization, up to 36 months
measure: Progression-free survival(PFS)
time frame: Up to the date of disease recurrence since the date of randomization, up to 36 months
description: Disease recurrence is defined as locoregional (esophageal bed or anastomotic or regional lymph nodes) or metastatic (supraclavicular lymph nodes or distant organs).
measure: Pathological response rate(pCR)
time frame: Up to the date of pathological reports obtained since the date of randomization, up to 12 months
description: The resected specimen following neo-adjuvant treatment are assessed by using standardised work up of the resection specimen in the pathology department and standardised histological criteria for tumour regression grading. The degree of histomorphologic regression is clarified into four categories as follows: grade 1, no evidence of vital residual tumor cells (pathological complete response); grade 2, less than 10% vital residual tumor cells; grade 3, 10 to 50%; and grade 4, more than 50%.
measure: R0 resection rate
time frame: Up to the date of pathological reports obtained since the date of randomization, up to 12 months
description: No vital tumor is presented at the proximal, distal, or circumferential resection margin, it is considered to be R0 resection. If a vital tumor is shown at 1 mm or less from the proximal, distal, or circumferential resection margin, it is considered to be microscopically positive (R1).
measure: Positive lymph nodes' number
time frame: Up to the date of pathological reports obtained since the date of randomization, up to 12 months
description: According to pathological reports, record the number of positive lymph nodes
measure: Treatment related complications
time frame: Up to 1 month after surgery since the data of randomization, up to 13 months
description: Number and severity of adverse events that are related to treatment of each patients, and hospital readmission.
measure: Quality of life(QOL)
time frame: Up to the end of follow-up since the data of surgery, up to 36 months
description: QOL is respectively evaluated at randomization and 1 month, 3 month, 6 month and yearly after surgery among patients by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C30) and EORTC QLQ-OES18
measure: Recurrence-free survival (RFS)
time frame: Up to the date of disease recurrence since the date of surgery, up to 36 months
description: RFS is defined in resected patients who achieved an R0 or R1 resection as the time interval from surgery to the date of first recurrence (local, regional or distant) or death, whichever comes first.
arm group label: Neoadjuvant chemoradiotherapy
arm group type: Experimental
description: Neoadjuvant chemoradiotherapy (NCRT) is performed followed by minimally invasive esophagectomy in enrolled patients.
arm group label: Neoadjuvant chemotherapy
arm group type: Active Comparator
description: Neoadjuvant chemotherapy (NCT) is performed followed by minimally invasive esophagectomy in enrolled patients.
intervention type: Procedure
intervention name: Neoadjuvant Chemoradiotherapy
description: Before surgery, patients in this group receive neoadjuvant chemoradiotherapy. A total dose of 40 Gy is delivered in 20 fractions (5 fractions per week) for 4 weeks. Chemotherapy is delivered concomitantly and composed of four cycles of paclitaxel 50mg per square meter of body-surface area and cisplatin 25mg per square meter of body-surface area weekly at the intervals of radiotherapy. After neoadjuvant therapy of 4-8 weeks, minimally invasive esophagectomy is performed.
arm group label: Neoadjuvant chemoradiotherapy
other name: Preoperative Chemoradiotherapy
intervention type: Procedure
intervention name: Neoadjuvant Chemotherapy
description: Before surgery, patients in this group receive neoadjuvant chemotherapy. Chemotherapy is delivered and composed of two cycles of paclitaxel 135mg per square meter of body-surface area and cisplatin 75mg per square meter of body-surface area every 4 weeks. After neoadjuvant therapy of 4-8 weeks, minimally invasive esophagectomy is performed.
arm group label: Neoadjuvant chemotherapy
other name: Preoperative Chemotherapy
intervention type: Procedure
intervention name: Minimally Invasive Esophagectomy
description: After neoadjuvant therapy, patients in groups receive minimally invasive esophagectomy
arm group label: Neoadjuvant chemoradiotherapy
arm group label: Neoadjuvant chemotherapy
other name: MIE
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Lijie Tan, MD
role: Study Director
affiliation: Shanghai Zhongshan Hospital
facility: 
country: China
url: http://www.jnccn.org/content/13/2/229.long
description: NCCN
url: http://ovidsp.tx.ovid.com/sp-3.23.1b/ovidweb.cgi?QS2=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
description: Wolters kluwer
url: http://journals.lww.com/annalsofsurgery/pages/articleviewer.aspx?year=2003&issue=10000&article=00004&type=abstract
description: Wolters kluwer
url: http://link.springer.com/article/10.1007%2Fs00464-008-9799-x
description: Springer
url: http://online.liebertpub.com/doi/abs/10.1089/lap.2014.0118
description: Atypon
url: http://link.springer.com/article/10.1007%2Fs00464-014-3753-x
description: Springer
url: http://jtd.amegroups.com/article/view/2243/3085
description: AME
url: http://icvts.oxfordjournals.org/content/19/2/263.long
description: Oxford University Press
url: http://link.springer.com/article/10.1007%2Fs11605-012-1824-7
description: Springer
url: http://link.springer.com/article/10.1007%2Fs11136-010-9742-1
description: Springer
citation: Luketich JD, Pennathur A, Awais O, Levy RM, Keeley S, Shende M, Christie NA, Weksler B, Landreneau RJ, Abbas G, Schuchert MJ, Nason KS. Outcomes after minimally invasive esophagectomy: review of over 1000 patients. Ann Surg. 2012 Jul;256(1):95-103. doi: 10.1097/SLA.0b013e3182590603.
PMID: 22668811
citation: Stahl M, Walz MK, Stuschke M, Lehmann N, Meyer HJ, Riera-Knorrenschild J, Langer P, Engenhart-Cabillic R, Bitzer M, Konigsrainer A, Budach W, Wilke H. Phase III comparison of preoperative chemotherapy compared with chemoradiotherapy in patients with locally advanced adenocarcinoma of the esophagogastric junction. J Clin Oncol. 2009 Feb 20;27(6):851-6. doi: 10.1200/JCO.2008.17.0506. Epub 2009 Jan 12.
PMID: 19139439
citation: Shen Y, Zhong M, Wu W, Wang H, Feng M, Tan L, Wang Q. The impact of tidal volume on pulmonary complications following minimally invasive esophagectomy: a randomized and controlled study. J Thorac Cardiovasc Surg. 2013 Nov;146(5):1267-73; discussion 1273-4. doi: 10.1016/j.jtcvs.2013.06.043. Epub 2013 Aug 28. Erratum In: J Thorac Cardiovasc Surg. 2014 Jan;147(1):544.
PMID: 23993028
citation: Feng M, Shen Y, Wang H, Tan L, Zhang Y, Khan MA, Wang Q. Thoracolaparoscopic esophagectomy: is the prone position a safe alternative to the decubitus position? J Am Coll Surg. 2012 May;214(5):838-44. doi: 10.1016/j.jamcollsurg.2011.12.047. Epub 2012 Mar 13.
PMID: 22421259
citation: Shen Y, Zhang Y, Tan L, Feng M, Wang H, Khan MA, Liang M, Wang Q. Extensive mediastinal lymphadenectomy during minimally invasive esophagectomy: optimal results from a single center. J Gastrointest Surg. 2012 Apr;16(4):715-21. doi: 10.1007/s11605-012-1824-7. Epub 2012 Jan 19.
PMID: 22258878
citation: Wang H, Feng M, Tan L, Wang Q. Comparison of the short-term quality of life in patients with esophageal cancer after subtotal esophagectomy via video-assisted thoracoscopic or open surgery. Dis Esophagus. 2010 Jul;23(5):408-14. doi: 10.1111/j.1442-2050.2009.01025.x. Epub 2009 Nov 23.
PMID: 19930404
citation: Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
PMID: 26808342
citation: Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4. Erratum In: CA Cancer J Clin. 2011 Mar-Apr;61(2):134.
PMID: 21296855
citation: Ychou M, Boige V, Pignon JP, Conroy T, Bouche O, Lebreton G, Ducourtieux M, Bedenne L, Fabre JM, Saint-Aubert B, Geneve J, Lasser P, Rougier P. Perioperative chemotherapy compared with surgery alone for resectable gastroesophageal adenocarcinoma: an FNCLCC and FFCD multicenter phase III trial. J Clin Oncol. 2011 May 1;29(13):1715-21. doi: 10.1200/JCO.2010.33.0597. Epub 2011 Mar 28.
PMID: 21444866
citation: Shapiro J, van Lanschot JJB, Hulshof MCCM, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch ORC, Ten Kate FJW, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Bilgen EJS, van Dekken H, van der Sangen MJC, Rozema T, Biermann K, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A; CROSS study group. Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1090-1098. doi: 10.1016/S1470-2045(15)00040-6. Epub 2015 Aug 5.
PMID: 26254683
citation: Sjoquist KM, Burmeister BH, Smithers BM, Zalcberg JR, Simes RJ, Barbour A, Gebski V; Australasian Gastro-Intestinal Trials Group. Survival after neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal carcinoma: an updated meta-analysis. Lancet Oncol. 2011 Jul;12(7):681-92. doi: 10.1016/S1470-2045(11)70142-5. Epub 2011 Jun 16.
PMID: 21684205
citation: Allum WH, Stenning SP, Bancewicz J, Clark PI, Langley RE. Long-term results of a randomized trial of surgery with or without preoperative chemotherapy in esophageal cancer. J Clin Oncol. 2009 Oct 20;27(30):5062-7. doi: 10.1200/JCO.2009.22.2083. Epub 2009 Sep 21.
PMID: 19770374
citation: Jang R, Darling G, Wong RK. Multimodality approaches for the curative treatment of esophageal cancer. J Natl Compr Canc Netw. 2015 Feb;13(2):229-38. doi: 10.6004/jnccn.2015.0029.
PMID: 25691613
citation: Mariette C, Dahan L, Mornex F, Maillard E, Thomas PA, Meunier B, Boige V, Pezet D, Robb WB, Le Brun-Ly V, Bosset JF, Mabrut JY, Triboulet JP, Bedenne L, Seitz JF. Surgery alone versus chemoradiotherapy followed by surgery for stage I and II esophageal cancer: final analysis of randomized controlled phase III trial FFCD 9901. J Clin Oncol. 2014 Aug 10;32(23):2416-22. doi: 10.1200/JCO.2013.53.6532. Epub 2014 Jun 30.
PMID: 24982463
citation: Kumagai K, Rouvelas I, Tsai JA, Mariosa D, Klevebro F, Lindblad M, Ye W, Lundell L, Nilsson M. Meta-analysis of postoperative morbidity and perioperative mortality in patients receiving neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal and gastro-oesophageal junctional cancers. Br J Surg. 2014 Mar;101(4):321-38. doi: 10.1002/bjs.9418. Epub 2014 Feb 3.
PMID: 24493117
citation: Biere SS, van Berge Henegouwen MI, Maas KW, Bonavina L, Rosman C, Garcia JR, Gisbertz SS, Klinkenbijl JH, Hollmann MW, de Lange ES, Bonjer HJ, van der Peet DL, Cuesta MA. Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial. Lancet. 2012 May 19;379(9829):1887-92. doi: 10.1016/S0140-6736(12)60516-9. Epub 2012 May 1.
PMID: 22552194
citation: Luketich JD, Alvelo-Rivera M, Buenaventura PO, Christie NA, McCaughan JS, Litle VR, Schauer PR, Close JM, Fernando HC. Minimally invasive esophagectomy: outcomes in 222 patients. Ann Surg. 2003 Oct;238(4):486-94; discussion 494-5. doi: 10.1097/01.sla.0000089858.40725.68.
PMID: 14530720
citation: Fabian T, Martin J, Katigbak M, McKelvey AA, Federico JA. Thoracoscopic esophageal mobilization during minimally invasive esophagectomy: a head-to-head comparison of prone versus decubitus positions. Surg Endosc. 2008 Nov;22(11):2485-91. doi: 10.1007/s00464-008-9799-x. Epub 2008 Mar 5.
PMID: 18320278
citation: Bakhos C, Oyasiji T, Elmadhun N, Kent M, Gangadharan S, Critchlow J, Fabian T. Feasibility of minimally invasive esophagectomy after neoadjuvant chemoradiation. J Laparoendosc Adv Surg Tech A. 2014 Oct;24(10):688-92. doi: 10.1089/lap.2014.0118. Epub 2014 Sep 2.
PMID: 25180663
citation: Warner S, Chang YH, Paripati H, Ross H, Ashman J, Harold K, Day R, Stucky CC, Rule W, Jaroszewski D. Outcomes of minimally invasive esophagectomy in esophageal cancer after neoadjuvant chemoradiotherapy. Ann Thorac Surg. 2014 Feb;97(2):439-45. doi: 10.1016/j.athoracsur.2013.09.042. Epub 2013 Nov 20.
PMID: 24266955
citation: Burmeister BH, Thomas JM, Burmeister EA, Walpole ET, Harvey JA, Thomson DB, Barbour AP, Gotley DC, Smithers BM. Is concurrent radiation therapy required in patients receiving preoperative chemotherapy for adenocarcinoma of the oesophagus? A randomised phase II trial. Eur J Cancer. 2011 Feb;47(3):354-60. doi: 10.1016/j.ejca.2010.09.009.
PMID: 21084184
citation: Li J, Shen Y, Tan L, Feng M, Wang H, Xi Y, Wang Q. Is minimally invasive esophagectomy beneficial to elderly patients with esophageal cancer? Surg Endosc. 2015 Apr;29(4):925-30. doi: 10.1007/s00464-014-3753-x. Epub 2014 Sep 24.
PMID: 25249141
citation: Shen Y, Feng M, Tan L, Wang H, Li J, Xi Y, Wang Q. Thoracoscopic esophagectomy in prone versus decubitus position: ergonomic evaluation from a randomized and controlled study. Ann Thorac Surg. 2014 Sep;98(3):1072-8. doi: 10.1016/j.athoracsur.2014.04.107. Epub 2014 Jul 16.
PMID: 25038015
citation: Li J, Shen Y, Tan L, Feng M, Wang H, Xi Y, Leng Y, Wang Q. Cervical triangulating stapled anastomosis: technique and initial experience. J Thorac Dis. 2014 May;6 Suppl 3(Suppl 3):S350-4. doi: 10.3978/j.issn.2072-1439.2014.02.06.
PMID: 24876941
citation: Shen Y, Wang H, Feng M, Tan L, Wang Q. The effect of narrowed gastric conduits on anastomotic leakage following minimally invasive oesophagectomy. Interact Cardiovasc Thorac Surg. 2014 Aug;19(2):263-8. doi: 10.1093/icvts/ivu151. Epub 2014 May 20.
PMID: 24847029
citation: Shen Y, Feng M, Khan MA, Wang H, Tan L, Wang Q. A simple method minimizes chylothorax after minimally invasive esophagectomy. J Am Coll Surg. 2014 Jan;218(1):108-12. doi: 10.1016/j.jamcollsurg.2013.09.014. Epub 2013 Nov 7.
PMID: 24211053
citation: Wang H, Tan L, Feng M, Zhang Y, Wang Q. Comparison of the short-term health-related quality of life in patients with esophageal cancer with different routes of gastric tube reconstruction after minimally invasive esophagectomy. Qual Life Res. 2011 Mar;20(2):179-89. doi: 10.1007/s11136-010-9742-1. Epub 2010 Sep 21.
PMID: 20857337
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Esophageal Squamous Cell Carcinoma
sharing ipd: Undecided