<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/NCT02976909</url>
  </required_header>
  <id_info>
    <org_study_id>TPF-1</org_study_id>
    <nct_id>NCT02976909</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of TPF Induction Chemotherapy for Borderline-resectable Esophageal Squamous Cell Carcinoma</brief_title>
  <official_title>Paclitaxel In Combination With Cisplatin and 5-fluorouracil(TPF) Induction Chemotherapy for Locally Advanced Borderline-resectable Esophageal Squamous Cell Carcinoma: A Phase II Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuhong Li</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial studies the efficacy and safty of paclitaxel in combination with cisplatin and&#xD;
      5-fluorouracil(TPF) induction chemotherapy for locally advanced borderline-resectable&#xD;
      esophageal squamous cell carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Esophageal cancer is one of the most common malignant tumors in China. In Asian countries,&#xD;
      esophageal squamous carcinoma is the main pathological type of esophageal carcinoma.&#xD;
      Prognosis of esophageal squamous carcinoma is usually poor and surgery is the only radical&#xD;
      treatment. However, the optimal therapy pattern for local advanced esophageal carcinoma is&#xD;
      still unclear. Part of the patients that clinical staging as T4 and with bulky lymph node&#xD;
      metastasis are initially diagnosed as borderline-resectable, which means patients may be able&#xD;
      to undergo R0 resection. However, for patients who are diagnosed as borderline-resectable&#xD;
      esophageal carcinoma, there are still no sufficient studies implicate that how to improve R0&#xD;
      resection rate by convertion chemotherapy. Cisplatin in combination with 5-FU and docetaxel&#xD;
      regimen(DCF) was reported as effective neoadjuvant chemotherapy in treating esophageal&#xD;
      squamous carcinoma. However, studies also showed that the DCF regimen caused severe adverse&#xD;
      reaction. The mechanism of paclitaxel is similar to docetaxel while with less adverse events&#xD;
      than docetaxel. Based on the research situation mentioned above, the investigators decided to&#xD;
      conduct a phase II clinical trial to further explore the efficacy and safety of paclitaxel in&#xD;
      combination with cisplatin and 5-FU (TPF) induction chemotherapy for locally advanced&#xD;
      borderline-resectable esophageal squamous carcinoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>R0 resection rate</measure>
    <time_frame>following resection for up to 36 months</time_frame>
    <description>The rate of R0 resection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pathologic complete response rate</measure>
    <time_frame>following resection for up to 36 months</time_frame>
    <description>The rate of pathologic complete response following surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS</measure>
    <time_frame>for up to 36 months</time_frame>
    <description>the duration from enrollment to the patient's death (all causes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS</measure>
    <time_frame>for up to 36 months</time_frame>
    <description>the duration from enrollment to tumour progression or the patient's death (all causes) (whichever comes first)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse envents</measure>
    <time_frame>for up to 12 months</time_frame>
    <description>Incidence of AEs and SAEs during the study.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Esophageal Squamous Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Paclitaxel+Cisplatin+5fluorouracil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive the following chemotherapy: Paclitaxel 135mg/m2 IV over 3 hours on Day 1; Cisplatin 75mg/m2 IV over 1 hours on Day 1; 5-FU 4g/m2 for 5 days continuous infusion from Day 1 to Day 5.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel+Cisplatin+5fluorouracil</intervention_name>
    <description>Patients will receive the following chemotherapy: Paclitaxel 135mg/m2 IV over 3 hours on Day 1; Cisplatin 75mg/m2 IV over 1 hours on Day 1; 5-FU 4g/m2 for 5 days continuous infusion from Day 1 to Day 5.</description>
    <arm_group_label>Paclitaxel+Cisplatin+5fluorouracil</arm_group_label>
    <other_name>Paclitaxel</other_name>
    <other_name>Cisplatin</other_name>
    <other_name>5fluorouracil</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients should be voluntary to the trial and provide with signed informed consent.&#xD;
&#xD;
          2. Male or female patients, age:18-70 years old&#xD;
&#xD;
          3. Confirmed by histology of thoracic esophageal squamous cell carcinoma without&#xD;
             metastasis and diagnosed as boundary resectable by Multidisciplinary consultation,&#xD;
             including cT4 and/or bulky lymphadenopathy that may invade nearby organs(such as the&#xD;
             great vessels, trachea and heart, etc.)&#xD;
&#xD;
          4. Measurable or unmeasurable lesions according the RECIST 1.1 criteria.&#xD;
&#xD;
          5. No previous chemotherapy or radiotherapy.&#xD;
&#xD;
          6. Life expectancy ≥ 3 months.&#xD;
&#xD;
          7. ECOG PS 0-1.&#xD;
&#xD;
          8. Blood routine within 7 days：Hb ≥9g/L，NE ≥1.5×109/L，PLT ≥100×109/L；&#xD;
&#xD;
          9. Hepatic and renal function：TB &lt;1.5 UNL， Cr&lt; 1.5× UNL， AST / ALT &lt; 2.5× UNL， ALP &lt; 5.0&#xD;
             × UNL。&#xD;
&#xD;
         10. No severe complications such as active digestive tract hemorrhage, perforation,&#xD;
             jaundice, gastrointestinal obstruction, non-cancerous fever &gt; 38 ℃&#xD;
&#xD;
         11. Fertile patients should take effective contraceptive measures.&#xD;
&#xD;
         12. Patients should have good compliance and cooperate with the evaluation of efficacy and&#xD;
             adverse events and follow-ups according to the research plan.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Cervical esophageal carcinoma.&#xD;
&#xD;
          2. Known severe hypersensitivity to drugs in the regimen.&#xD;
&#xD;
          3. Patient has a concurrent malignancy or has a malignancy within 5 years of study&#xD;
             enrollment(with the exception of nonmelanoma skin cancer or cervical carcinoma in&#xD;
             situ).&#xD;
&#xD;
          4. Evidence of serious heart disease, including recorded history of congestive&#xD;
             heart-failure, uncontrolled serious arrhythmia, angina that needs treatment of drugs,&#xD;
             clinical diagnosed cardiac valve disease, history of serious myocardial infarction and&#xD;
             intractable hypertension.&#xD;
&#xD;
          5. Evidence of chronic diarrhea(≥4 times/day) or renal dysfunction.&#xD;
&#xD;
          6. Evidence of active infection or active epidemic disease.&#xD;
&#xD;
          7. Psychiatric illness that would prevent the patient from giving informed consent&#xD;
&#xD;
          8. Pregnant or lactating women.&#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>Yu-hong Li, MD, Ph D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sun Yat-sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>February 14, 2023</last_update_submitted>
  <last_update_submitted_qc>February 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Yuhong Li</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
    <mesh_term>Cisplatin</mesh_term>
    <mesh_term>Fluorouracil</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/NCT02976909
org study id: TPF-1
nct id: NCT02976909
lead sponsor: 
has dmc: Yes
This trial studies the efficacy and safty of paclitaxel in combination with cisplatin and
      5-fluorouracil(TPF) induction chemotherapy for locally advanced borderline-resectable
      esophageal squamous cell carcinoma.
Esophageal cancer is one of the most common malignant tumors in China. In Asian countries,
      esophageal squamous carcinoma is the main pathological type of esophageal carcinoma.
      Prognosis of esophageal squamous carcinoma is usually poor and surgery is the only radical
      treatment. However, the optimal therapy pattern for local advanced esophageal carcinoma is
      still unclear. Part of the patients that clinical staging as T4 and with bulky lymph node
      metastasis are initially diagnosed as borderline-resectable, which means patients may be able
      to undergo R0 resection. However, for patients who are diagnosed as borderline-resectable
      esophageal carcinoma, there are still no sufficient studies implicate that how to improve R0
      resection rate by convertion chemotherapy. Cisplatin in combination with 5-FU and docetaxel
      regimen(DCF) was reported as effective neoadjuvant chemotherapy in treating esophageal
      squamous carcinoma. However, studies also showed that the DCF regimen caused severe adverse
      reaction. The mechanism of paclitaxel is similar to docetaxel while with less adverse events
      than docetaxel. Based on the research situation mentioned above, the investigators decided to
      conduct a phase II clinical trial to further explore the efficacy and safety of paclitaxel in
      combination with cisplatin and 5-FU (TPF) induction chemotherapy for locally advanced
      borderline-resectable esophageal squamous carcinoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: R0 resection rate
time frame: following resection for up to 36 months
description: The rate of R0 resection
measure: pathologic complete response rate
time frame: following resection for up to 36 months
description: The rate of pathologic complete response following surgery
measure: OS
time frame: for up to 36 months
description: the duration from enrollment to the patient's death (all causes)
measure: PFS
time frame: for up to 36 months
description: the duration from enrollment to tumour progression or the patient's death (all causes) (whichever comes first)
measure: Adverse envents
time frame: for up to 12 months
description: Incidence of AEs and SAEs during the study.
arm group label: Paclitaxel+Cisplatin+5fluorouracil
arm group type: Experimental
description: Patients will receive the following chemotherapy: Paclitaxel 135mg/m2 IV over 3 hours on Day 1; Cisplatin 75mg/m2 IV over 1 hours on Day 1; 5-FU 4g/m2 for 5 days continuous infusion from Day 1 to Day 5.
intervention type: Drug
intervention name: Paclitaxel+Cisplatin+5fluorouracil
description: Patients will receive the following chemotherapy: Paclitaxel 135mg/m2 IV over 3 hours on Day 1; Cisplatin 75mg/m2 IV over 1 hours on Day 1; 5-FU 4g/m2 for 5 days continuous infusion from Day 1 to Day 5.
arm group label: Paclitaxel+Cisplatin+5fluorouracil
other name: Paclitaxel
other name: Cisplatin
other name: 5fluorouracil
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yu-hong Li, MD, Ph D
role: Principal Investigator
affiliation: Sun Yat-sen University
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Yuhong Li
investigator title: Clinical Professor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Esophageal Squamous Cell Carcinoma
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel
mesh term: Cisplatin
mesh term: Fluorouracil