<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/NCT03002064</url>
  </required_header>
  <id_info>
    <org_study_id>SYSUCC-ESO-01</org_study_id>
    <nct_id>NCT03002064</nct_id>
  </id_info>
  <brief_title>Docetaxol Plus Cisplatin Versus 5-Fu Plus Cisplatin as 1st-line Chemotherapy in Advanced ESCC Patients</brief_title>
  <official_title>Docetaxel Plus Cisplatin Versus 5-fluorouracil Plus Cisplatin as First-line Treatment for Metastatic Esophageal Squamous Patients: a Prospective Multicenter, Randomized Controlled Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase III clinical trial to compare the efficacy of docetaxel plus cisplatin versus&#xD;
      5-Fu plus cisplatin in the first line chemotherapy for advanced or metastatic esophageal&#xD;
      squamous carcinoma patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Esophageal cancer is the 6th most common cause of cancer deaths worldwide and it is an&#xD;
      endemic in many parts of the world, particularly in the developing countries, including&#xD;
      China. Histologically, esophageal cancer can be classified as adenocarcinoma and esophageal&#xD;
      squamous cell. carcinoma (ESCC) which is the most common histology in Asia. For locally&#xD;
      advanced or metastatic ESCC patients, chemotherapy can improve overall survival (OS) and&#xD;
      progression free survival (PFS). There is no standard first-line chemotherapy for ESCC&#xD;
      patients. Cisplatin (DDP) plus fluorouracil is the most common used combination with a&#xD;
      response rate of 25-35%. Previous studies showed that the combination of paclitaxel with&#xD;
      cisplatin had good tolerance and efficacy to esophageal carcinoma. This is a prospective&#xD;
      randomized control phase III clinical trial to compare the efficacy and safety between&#xD;
      docetaxel/cisplatin and 5-Fu/cisplatin as the 1st line treatment in advanced or metastatic&#xD;
      esophageal carcinoma patients.&#xD;
&#xD;
      Sample size:&#xD;
&#xD;
      This is a non-inferior study. The planned sample size was 358 patients, allowing for a 10%&#xD;
      dropout rate and assuming the median progression free survival was 5.5 months in the&#xD;
      experimental group and 4 months in the control group with a hazard ratio of 0.727, α=0.05,&#xD;
      β=0.2. The planned enrolled time was 36 months and 12 months of follow up. The ratio between&#xD;
      control and experimental group is 1:1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>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>Progression free survival</measure>
    <time_frame>36 months</time_frame>
    <description>From the date of randomization until the date of first documented relapse of disease or date of death from any cause, whichever came first</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>36 months</time_frame>
    <description>From the date of randomization until the date of death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate</measure>
    <time_frame>36 months</time_frame>
    <description>Including complete response and partial response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grade 3 and 4 toxicities</measure>
    <time_frame>36 months</time_frame>
    <description>According to the CTCAE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life--Score of the questionnaire</measure>
    <time_frame>36 months</time_frame>
    <description>EORTC QLQ-C30 and QLQ-OES18 questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">358</enrollment>
  <condition>Esophagus Cancer</condition>
  <condition>Chemotherapy Effects</condition>
  <arm_group>
    <arm_group_label>DP group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Docetaxel plus cisplatin. Docetaxel: 60mg per square metre on day 1 and Cisplatin: 60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PF group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cisplatin plus 5-fluorouracil. Cisplatin: 60mg per square metre on day 1 and 5-fluorouracil 3750mg per square metre, civ 120 hours every 3 weeks till progression or at most 6 cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles.</description>
    <arm_group_label>DP group</arm_group_label>
    <other_name>Docetaxol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluorouracil</intervention_name>
    <description>5-fluorouracil 3750mg per square metre, civ 120 hours every 3 weeks till progression or at most 6 cycles</description>
    <arm_group_label>PF group</arm_group_label>
    <other_name>5-Fu</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Cisplatin: 60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles</description>
    <arm_group_label>DP group</arm_group_label>
    <arm_group_label>PF group</arm_group_label>
    <other_name>DDP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients must give written informed consent signed voluntarily by patients themselves&#xD;
             or their supervisors witted by doctors.&#xD;
&#xD;
          2. Patients must have histologically confirmed esophageal squamous cell carcinoma without&#xD;
             prior treatments including surgery, chemotherapy, radiotherapy, and targeting&#xD;
             treatment. Patients were allowed to have palliative radiotherapy 3 months before the&#xD;
             enrollment and the target lesions should not be within the radiotherapy region. The&#xD;
             last date of adjuvant therapy should be over 6 months before the enrollment.&#xD;
&#xD;
          3. With measurable or evaluable disease according to the Response Evaluation Criteria in&#xD;
             Solid Tumors (RECIST) criteria.&#xD;
&#xD;
          4. With an expected life expectancy of ≥ 3 months.&#xD;
&#xD;
          5. With a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG)&#xD;
             scale.&#xD;
&#xD;
          6. Without serious system dysfunction and could tolerate chemotherapy.&#xD;
&#xD;
          7. Patients must have normal bone marrow function with a hemoglobin (HGB) of ≥90g/L, an&#xD;
             white blood cell (WBC) counts of ≥4.0×10^9/L，a neutrophil count of ≥2.0×10^9/L, , a&#xD;
             platelet count of ≥100×10^9/L.&#xD;
&#xD;
          8. Patients must have normal liver and renal function with a total bilirubin (TBil) of&#xD;
             ≤1.5 upper normal limitation (UNL), a creatinine (Cr) of ≤ 1.0 UNL, alanine&#xD;
             aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL.&#xD;
&#xD;
          9. Patients must have normal electrocardiogram results and no history of congestive heart&#xD;
             failure.&#xD;
&#xD;
         10. Women of childbearing age should voluntarily take contraceptive measures. Without drug&#xD;
             addition&#xD;
&#xD;
         11. Patients must be with good compliance and agree to accept follow-up of disease&#xD;
             progression and adverse events.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Allergic to known drug&#xD;
&#xD;
          2. Patients who have received prior treatment including chemotherapy, radiotherapy and&#xD;
             surgery for the advanced or metastatic diseases.&#xD;
&#xD;
          3. Receive docetaxel within 6 months as adjuvant or neoadjuvant chemotherapy.&#xD;
&#xD;
          4. Brain metastasis.&#xD;
&#xD;
          5. Without measurable or evaluable disease.&#xD;
&#xD;
          6. With history of other tumors except for those of cervical carcinoma in situ or skin&#xD;
             basal cell carcinoma who had been completely treated and without relapse in last 5&#xD;
             years.&#xD;
&#xD;
          7. With serious diseases such as congestive heart failure, uncontrolled myocardial&#xD;
             infarction and arrhythmia, liver failure and renal failure.&#xD;
&#xD;
          8. With neurological or psychiatric abnormalities that affect cognitive.&#xD;
&#xD;
          9. Pregnant or lactated women (premenopausal women must give urine pregnancy test before&#xD;
             enrollment)&#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>Rui-Hua Xu, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rui-Hua Xu, MD, PhD</last_name>
    <phone>86-020-87343333</phone>
    <email>xurh@sysucc.org.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Miao-Zhen Qiu, MD, PhD</last_name>
    <phone>86-020-87342490</phone>
    <email>qiumzh@sysucc.org.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cancer center of Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rui-Hua Xu, MD, PhD</last_name>
      <phone>86-020-87343333</phone>
      <email>xurh@sysucc.org.cn</email>
    </contact>
    <contact_backup>
      <last_name>Miao-Zhen Qiu, MD, PhD</last_name>
      <phone>86-020-87342490</phone>
      <email>qiumzh@sysucc.org.cn</email>
    </contact_backup>
    <investigator>
      <last_name>Miao-zhen Qiu, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rui-hua Xu, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>December 23, 2016</last_update_submitted>
  <last_update_submitted_qc>December 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Ruihua Xu</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Esophagus squamous carcinoma</keyword>
  <keyword>First-line chemotherapy</keyword>
  <keyword>Docetaxel</keyword>
  <keyword>Cisplatin</keyword>
  <keyword>5-fluorouracil</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Docetaxel</mesh_term>
    <mesh_term>Fluorouracil</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03002064
org study id: SYSUCC-ESO-01
nct id: NCT03002064
lead sponsor: 
has dmc: No
This is a phase III clinical trial to compare the efficacy of docetaxel plus cisplatin versus
      5-Fu plus cisplatin in the first line chemotherapy for advanced or metastatic esophageal
      squamous carcinoma patients.
Esophageal cancer is the 6th most common cause of cancer deaths worldwide and it is an
      endemic in many parts of the world, particularly in the developing countries, including
      China. Histologically, esophageal cancer can be classified as adenocarcinoma and esophageal
      squamous cell. carcinoma (ESCC) which is the most common histology in Asia. For locally
      advanced or metastatic ESCC patients, chemotherapy can improve overall survival (OS) and
      progression free survival (PFS). There is no standard first-line chemotherapy for ESCC
      patients. Cisplatin (DDP) plus fluorouracil is the most common used combination with a
      response rate of 25-35%. Previous studies showed that the combination of paclitaxel with
      cisplatin had good tolerance and efficacy to esophageal carcinoma. This is a prospective
      randomized control phase III clinical trial to compare the efficacy and safety between
      docetaxel/cisplatin and 5-Fu/cisplatin as the 1st line treatment in advanced or metastatic
      esophageal carcinoma patients.

      Sample size:

      This is a non-inferior study. The planned sample size was 358 patients, allowing for a 10%
      dropout rate and assuming the median progression free survival was 5.5 months in the
      experimental group and 4 months in the control group with a hazard ratio of 0.727, α=0.05,
      β=0.2. The planned enrolled time was 36 months and 12 months of follow up. The ratio between
      control and experimental group is 1:1.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression free survival
time frame: 36 months
description: From the date of randomization until the date of first documented relapse of disease or date of death from any cause, whichever came first
measure: Overall survival
time frame: 36 months
description: From the date of randomization until the date of death from any cause.
measure: Response rate
time frame: 36 months
description: Including complete response and partial response
measure: Grade 3 and 4 toxicities
time frame: 36 months
description: According to the CTCAE
measure: Quality of life--Score of the questionnaire
time frame: 36 months
description: EORTC QLQ-C30 and QLQ-OES18 questionnaire.
arm group label: DP group
arm group type: Experimental
description: Docetaxel plus cisplatin. Docetaxel: 60mg per square metre on day 1 and Cisplatin: 60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles.
arm group label: PF group
arm group type: Active Comparator
description: Cisplatin plus 5-fluorouracil. Cisplatin: 60mg per square metre on day 1 and 5-fluorouracil 3750mg per square metre, civ 120 hours every 3 weeks till progression or at most 6 cycles.
intervention type: Drug
intervention name: Docetaxel
description: 60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles.
arm group label: DP group
other name: Docetaxol
intervention type: Drug
intervention name: Fluorouracil
description: 5-fluorouracil 3750mg per square metre, civ 120 hours every 3 weeks till progression or at most 6 cycles
arm group label: PF group
other name: 5-Fu
intervention type: Drug
intervention name: Cisplatin
description: Cisplatin: 60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles
arm group label: DP group
arm group label: PF group
other name: DDP
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Rui-Hua Xu, MD, PhD
role: Principal Investigator
affiliation: Sun Yat-sen University
last name: Rui-Hua Xu, MD, PhD
phone: 86-020-87343333
email: xurh@sysucc.org.cn
last name: Miao-Zhen Qiu, MD, PhD
phone: 86-020-87342490
email: qiumzh@sysucc.org.cn
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Ruihua Xu
investigator title: Professor
mesh term: Esophageal Neoplasms
mesh term: Docetaxel
mesh term: Fluorouracil
sharing ipd: No