<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/NCT01665625</url>
  </required_header>
  <id_info>
    <org_study_id>XHDD 003</org_study_id>
    <nct_id>NCT01665625</nct_id>
  </id_info>
  <brief_title>Regional Versus Systemic Chemotherapy in the Treatment of Unresectable Pancreatic Cancer</brief_title>
  <official_title>A Prospective Randomized Trial of Regional Versus Systemic Continuous Gemcitabine Chemotherapy in the Treatment of Unresectable Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Air Force Military Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Air Force Military Medical University, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Systemic chemotherapy with cytotoxic drug is of limited effectiveness in advanced pancreatic&#xD;
      cancer patients. Gemcitabine has been used as the first-line drug for advance pancreatic&#xD;
      cancer for over two decades and combinations of gemcitabine with different chemotherapeutic&#xD;
      drugs have been investigated to improve the outcomes of pancreatic cancer. However, no&#xD;
      substantial improvement in patient survival has been achieved. Locoregional chemotherapy via&#xD;
      intra-arterial perfusion or chemoemoblization takes advantage of the increasing local drug&#xD;
      concentrations and reducing systemic toxicities. In this study, the investigators hypothesis&#xD;
      that artery infusion chemotherapy had a better antitumor effect than systemic chemotherapy.&#xD;
      The investigators will analyze and evaluate the effect and safety of an implanted&#xD;
      percutaneous left subclavian artery port-catheter drug delivery system for regional&#xD;
      chemotherapy of inoperable pancreatic carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">February 2016</completion_date>
  <primary_completion_date type="Anticipated">August 2015</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 surviva</measure>
    <time_frame>36 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Benefit Rate</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The median progression-free survival PFS</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug Toxicity</measure>
    <time_frame>18 months</time_frame>
    <description>The grading standards of the World Health Organization for acute and subacute toxicity of anticancer drugs will be used to grade toxicity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>surgical complications</measure>
    <time_frame>18 months</time_frame>
    <description>Major surgical complications included allergic reaction to the contrast agent, local hematoma, pneumothorax, puncture site bleeding, wound infection, delayed healing or cracking, port-catheter blockage, and necrosis of the tissue surrounding the port-catheter.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Unresectable Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>regional interventional chemotherapy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>systemic chemotherapy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>regional interventional chemotherapy group</intervention_name>
    <description>The patients in experimental group were monitored by X-ray imaging. A 0.038 super-sliding guide wire was inserted after successful puncture, and when site of the pancreatic carcinoma was reconfirmed by conventional angiography, a 5F cobra catheter was used to place the port-catheter drug delivery system in the celiac artery (pancreatic head) or the hepatic artery (pancreatic body and tail). Finally, the port-catheter was embedded under the left upper chest.</description>
    <arm_group_label>regional interventional chemotherapy group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed written informed consent&#xD;
&#xD;
          -  Karnofsky score &gt; 60,&#xD;
&#xD;
          -  Expected survival &gt; 3 months,&#xD;
&#xD;
          -  Liver, kidney function and routine blood test within normal range&#xD;
&#xD;
          -  No serious cardiopulmonary dysfunction&#xD;
&#xD;
          -  No acute infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Uncontrolled internal diseases&#xD;
&#xD;
          -  Past or the presence of other malignancy&#xD;
&#xD;
          -  Those who had received immunosuppressive therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guohong Han, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xijing Hospital of Digestive Diseases, Fourth Military Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jun Tie, PH.D., MD</last_name>
    <phone>+86-29-84771528</phone>
    <email>tiejun7776@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xijing Hospital of Digestive Diseases, Fourth Military Medical University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xijing Hospital of Digestive Diseases, Fourth Military Medical University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>GuoHong Han, MD</last_name>
      <phone>86-29-84775221</phone>
      <email>hangh@fmmu.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Jun Tie, PH.D.,MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Han GH, Yin ZX, Meng XJ, He CY, Zhang HB, Sun AH, Wu KC, Ding J, Fan DM. Prospective randomized clinical trial of two drug delivery pathway in the treatment of inoperable advanced pancreatic carcinoma. Chin J Dig Dis. 2006;7(1):45-8. doi: 10.1111/j.1443-9573.2006.00243.x.</citation>
    <PMID>16412037</PMID>
  </reference>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>July 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>August 10, 2012</last_update_submitted>
  <last_update_submitted_qc>August 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Air Force Military Medical University, China</investigator_affiliation>
    <investigator_full_name>Guohong Han</investigator_full_name>
    <investigator_title>Head of Department of Digestive Interventional Radiology</investigator_title>
  </responsible_party>
  <keyword>Pancreatic cancer</keyword>
  <keyword>Intra-arterial infusion</keyword>
  <keyword>Gemcitabine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_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/NCT01665625
org study id: XHDD 003
nct id: NCT01665625
lead sponsor: 
has dmc: Yes
Systemic chemotherapy with cytotoxic drug is of limited effectiveness in advanced pancreatic
      cancer patients. Gemcitabine has been used as the first-line drug for advance pancreatic
      cancer for over two decades and combinations of gemcitabine with different chemotherapeutic
      drugs have been investigated to improve the outcomes of pancreatic cancer. However, no
      substantial improvement in patient survival has been achieved. Locoregional chemotherapy via
      intra-arterial perfusion or chemoemoblization takes advantage of the increasing local drug
      concentrations and reducing systemic toxicities. In this study, the investigators hypothesis
      that artery infusion chemotherapy had a better antitumor effect than systemic chemotherapy.
      The investigators will analyze and evaluate the effect and safety of an implanted
      percutaneous left subclavian artery port-catheter drug delivery system for regional
      chemotherapy of inoperable pancreatic carcinoma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: overall surviva
time frame: 36 months
measure: Clinical Benefit Rate
time frame: 12 months
measure: The median progression-free survival PFS
time frame: 12 months
measure: Drug Toxicity
time frame: 18 months
description: The grading standards of the World Health Organization for acute and subacute toxicity of anticancer drugs will be used to grade toxicity.
measure: surgical complications
time frame: 18 months
description: Major surgical complications included allergic reaction to the contrast agent, local hematoma, pneumothorax, puncture site bleeding, wound infection, delayed healing or cracking, port-catheter blockage, and necrosis of the tissue surrounding the port-catheter.
arm group label: regional interventional chemotherapy group
arm group type: Experimental
arm group label: systemic chemotherapy
arm group type: No Intervention
intervention type: Procedure
intervention name: regional interventional chemotherapy group
description: The patients in experimental group were monitored by X-ray imaging. A 0.038 super-sliding guide wire was inserted after successful puncture, and when site of the pancreatic carcinoma was reconfirmed by conventional angiography, a 5F cobra catheter was used to place the port-catheter drug delivery system in the celiac artery (pancreatic head) or the hepatic artery (pancreatic body and tail). Finally, the port-catheter was embedded under the left upper chest.
arm group label: regional interventional chemotherapy group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Guohong Han, MD
role: Principal Investigator
affiliation: Xijing Hospital of Digestive Diseases, Fourth Military Medical University
last name: Jun Tie, PH.D., MD
phone: +86-29-84771528
email: tiejun7776@163.com
facility: 
facility: 
contact: 
investigator: 
country: China
citation: Han GH, Yin ZX, Meng XJ, He CY, Zhang HB, Sun AH, Wu KC, Ding J, Fan DM. Prospective randomized clinical trial of two drug delivery pathway in the treatment of inoperable advanced pancreatic carcinoma. Chin J Dig Dis. 2006;7(1):45-8. doi: 10.1111/j.1443-9573.2006.00243.x.
PMID: 16412037
responsible party type: Principal Investigator
investigator affiliation: Air Force Military Medical University, China
investigator full name: Guohong Han
investigator title: Head of Department of Digestive Interventional Radiology
mesh term: Pancreatic Neoplasms