<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/NCT03779035</url>
  </required_header>
  <id_info>
    <org_study_id>EK2017144</org_study_id>
    <nct_id>NCT03779035</nct_id>
  </id_info>
  <brief_title>Adjuvant Chemotherapy for Biliary Tract Cancer After Curative Resection</brief_title>
  <acronym>AdBTC-1</acronym>
  <official_title>Adjuvant Chemotherapy With Gemcitabine and Capecitabine Compared to Capecitabine for Biliary Tract Cancer After Curative Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Medical University Cancer Institute and Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin Medical University Cancer Institute and Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective, open-Label, comparative, randomized, controlled phase III trial was&#xD;
      designed to compare the clinical performance of gemcitabine with capecitabine vs.&#xD;
      capecitabine alone for patients with biliary tract cancer (BTC) after curative resection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, complete surgical resection represents the only potentially curative treatment&#xD;
      option for cholangiocarcinoma (CCA, including intrahepatic, hilar and distal CCA) and&#xD;
      gallbladder carcinoma (GBCA). Because of high rates of disease recurrence and poor survival&#xD;
      rates following surgical resection, postoperative treatment have been considered to improve&#xD;
      patient survival after resection of BTC. The systematic review showed a beneficial impact of&#xD;
      adjuvant treatment in BTC, particularly in patients with involved lymph nodes or resection&#xD;
      margins and distal or hilar CCA. However, in regard of the paucity of randomized data,&#xD;
      current guidelines recommend inclusion in clinical trials.&#xD;
&#xD;
      Previously, the data of the BILCAP trial showed an improvement in median overall survival for&#xD;
      capecitabine compared to observation alone for BTC, indicating capecitabine as the new&#xD;
      standard postoperative treatment after curative resection of BTC.&#xD;
&#xD;
      Previous phase II studies for advanced BTC showed superiority of the combination gemcitabine/&#xD;
      capecitabine regimen vs. the capecitabine monotherapy, the median OS was 12.7-14 vs. 7.9&#xD;
      months.&#xD;
&#xD;
      Based on these data, this AdBTC trial will was designed to compare the clinical performance&#xD;
      of gemcitabine with capecitabine vs. capecitabine alone for patients with biliary tract&#xD;
      cancer (BTC) after curative resection, aiming for superiority of the combination regimen vs.&#xD;
      the oral monotherapy. This will be based on the BILCAP protocol, applying the similar dosing,&#xD;
      assessments and dose modifications.&#xD;
&#xD;
      The primary endpoint is DFS and secondary endpoints include recurrence free survival, OS,&#xD;
      safety and tolerability of adjuvant CTx, quality of life, and patterns of disease recurrence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">December 15, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>Disease free survival (DFS) rate</measure>
    <time_frame>at 24 months</time_frame>
    <description>DFS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS) rate</measure>
    <time_frame>at 24 months</time_frame>
    <description>OS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease free survival (DFS) rate</measure>
    <time_frame>at 60 months</time_frame>
    <description>DFS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS) rate</measure>
    <time_frame>at 60 months</time_frame>
    <description>OS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of patients with hepatic or locoregional recurrence</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">460</enrollment>
  <condition>Cholangiocarcinoma</condition>
  <condition>Gall Bladder Carcinoma</condition>
  <arm_group>
    <arm_group_label>Gemcitabine plus Capecitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gemcitabine (1000 mg per square meter) on days 1 and 8 Capecitabine (1250 mg per square meter) twice a day on days 1-14. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Capecitabine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Capecitabine (1250 mg per square meter) twice a day on days 1-14. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <description>1000mg/m2</description>
    <arm_group_label>Gemcitabine plus Capecitabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <description>1250mg/m2</description>
    <arm_group_label>Capecitabine</arm_group_label>
    <arm_group_label>Gemcitabine plus Capecitabine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        DISEASE CHARACTERISTICS:&#xD;
&#xD;
          -  Histologically confirmed biliary tract cancer (including intrahepatic, extrahepatic,&#xD;
             hilar cholangiocarcinoma or muscle invasive gallbladder cancer or cancer of the distal&#xD;
             bile duct)&#xD;
&#xD;
          -  Must have undergone a radical surgical approach which includes liver resection,&#xD;
             pancreatic resection, or less commonly both&#xD;
&#xD;
          -  Patients with pathological evidence of microscopic involvement of the margins of the&#xD;
             excised specimen are eligible as long as resection is macroscopically complete&#xD;
&#xD;
          -  Must be able to start treatment within 12 weeks of surgery&#xD;
&#xD;
          -  No pancreatic or periampullary cancer&#xD;
&#xD;
          -  No mucosal gallbladder cancer&#xD;
&#xD;
        PATIENT CHARACTERISTICS:&#xD;
&#xD;
          -  ECOG performance status 0-2&#xD;
&#xD;
          -  Urea &lt; 1.5 times upper limit of normal (ULN)&#xD;
&#xD;
          -  Creatinine &lt; 1.5 times ULN&#xD;
&#xD;
          -  Glomerular filtration rate ≥ 60 mL/min (if &lt; 60 mL/min, adequate renal function for&#xD;
             capecitabine must be confirmed by isotope EDTA)&#xD;
&#xD;
          -  Hemoglobin ≥ 10 g/dL&#xD;
&#xD;
          -  WBC ≥ 3,000/mm³&#xD;
&#xD;
          -  Absolute neutrophil count ≥ 1,500/mm³&#xD;
&#xD;
          -  Platelet count ≥ 100,000/mm³&#xD;
&#xD;
          -  Bilirubin ≤ 3 times ULN&#xD;
&#xD;
          -  ALT and AST ≤ 5 times ULN&#xD;
&#xD;
          -  Adequate surgical biliary drainage with no evidence of infection&#xD;
&#xD;
          -  Not pregnant or nursing&#xD;
&#xD;
          -  Negative pregnancy test for women of childbearing age and childbearing potential&#xD;
&#xD;
          -  Fertile patients must use effective contraception during study treatment and for at&#xD;
             least 3 months after study treatment has ended&#xD;
&#xD;
          -  Must provide written informed consent&#xD;
&#xD;
          -  No history of other malignant diseases within the past 5 years&#xD;
&#xD;
          -  No serious coexisting medical condition likely to interfere with protocol treatment,&#xD;
             including a potential serious infection&#xD;
&#xD;
          -  No evidence of significant clinical disorder or laboratory finding that makes it&#xD;
             undesirable for the patient to participate in the trial&#xD;
&#xD;
          -  No psychological, familial, sociological, or geographical factors considered likely to&#xD;
             preclude study compliance&#xD;
&#xD;
          -  No other serious uncontrolled medical conditions&#xD;
&#xD;
          -  No unresolved biliary tree obstruction&#xD;
&#xD;
        PRIOR CONCURRENT THERAPY:&#xD;
&#xD;
          -  See Disease Characteristics&#xD;
&#xD;
          -  Completely recovered from prior surgery&#xD;
&#xD;
          -  No use of other investigational agents within 28 days prior to and during study&#xD;
             treatment&#xD;
&#xD;
          -  No prior chemotherapy or radiotherapy for biliary tract cancer&#xD;
&#xD;
          -  No other concurrent anticancer chemotherapy, radiotherapy, or investigational agent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Tianqiang Song, PH.D.</last_name>
    <phone>+86-022-23340123</phone>
    <phone_ext>3090</phone_ext>
    <email>tjchi@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Insititute and Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tianqiang Song, PH.D.</last_name>
      <email>tjchi@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 17, 2018</last_update_submitted>
  <last_update_submitted_qc>December 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>adjuvant chemotherapy</keyword>
  <keyword>cholangiocarcinoma</keyword>
  <keyword>invasive gall bladder carcinoma</keyword>
  <keyword>overall survival</keyword>
  <keyword>disease free survival</keyword>
  <keyword>Gemcitabine</keyword>
  <keyword>Capecitabine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangiocarcinoma</mesh_term>
    <mesh_term>Biliary Tract Neoplasms</mesh_term>
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Capecitabine</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/NCT03779035
org study id: EK2017144
nct id: NCT03779035
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
This prospective, open-Label, comparative, randomized, controlled phase III trial was
      designed to compare the clinical performance of gemcitabine with capecitabine vs.
      capecitabine alone for patients with biliary tract cancer (BTC) after curative resection.
Currently, complete surgical resection represents the only potentially curative treatment
      option for cholangiocarcinoma (CCA, including intrahepatic, hilar and distal CCA) and
      gallbladder carcinoma (GBCA). Because of high rates of disease recurrence and poor survival
      rates following surgical resection, postoperative treatment have been considered to improve
      patient survival after resection of BTC. The systematic review showed a beneficial impact of
      adjuvant treatment in BTC, particularly in patients with involved lymph nodes or resection
      margins and distal or hilar CCA. However, in regard of the paucity of randomized data,
      current guidelines recommend inclusion in clinical trials.

      Previously, the data of the BILCAP trial showed an improvement in median overall survival for
      capecitabine compared to observation alone for BTC, indicating capecitabine as the new
      standard postoperative treatment after curative resection of BTC.

      Previous phase II studies for advanced BTC showed superiority of the combination gemcitabine/
      capecitabine regimen vs. the capecitabine monotherapy, the median OS was 12.7-14 vs. 7.9
      months.

      Based on these data, this AdBTC trial will was designed to compare the clinical performance
      of gemcitabine with capecitabine vs. capecitabine alone for patients with biliary tract
      cancer (BTC) after curative resection, aiming for superiority of the combination regimen vs.
      the oral monotherapy. This will be based on the BILCAP protocol, applying the similar dosing,
      assessments and dose modifications.

      The primary endpoint is DFS and secondary endpoints include recurrence free survival, OS,
      safety and tolerability of adjuvant CTx, quality of life, and patterns of disease recurrence.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease free survival (DFS) rate
time frame: at 24 months
description: DFS
measure: Overall survival (OS) rate
time frame: at 24 months
description: OS
measure: Disease free survival (DFS) rate
time frame: at 60 months
description: DFS
measure: Overall survival (OS) rate
time frame: at 60 months
description: OS
measure: The rate of patients with hepatic or locoregional recurrence
time frame: 24 months
arm group label: Gemcitabine plus Capecitabine
arm group type: Experimental
description: Gemcitabine (1000 mg per square meter) on days 1 and 8 Capecitabine (1250 mg per square meter) twice a day on days 1-14. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
arm group label: Capecitabine
arm group type: Active Comparator
description: Capecitabine (1250 mg per square meter) twice a day on days 1-14. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
intervention type: Drug
intervention name: Gemcitabine
description: 1000mg/m2
arm group label: Gemcitabine plus Capecitabine
intervention type: Drug
intervention name: Capecitabine
description: 1250mg/m2
arm group label: Capecitabine
arm group label: Gemcitabine plus Capecitabine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tianqiang Song, PH.D.
phone: +86-022-23340123
phone ext: 3090
email: tjchi@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Cholangiocarcinoma
mesh term: Biliary Tract Neoplasms
mesh term: Urinary Bladder Neoplasms
mesh term: Gemcitabine
mesh term: Capecitabine