<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/NCT02243358</url>
  </required_header>
  <id_info>
    <org_study_id>HFHS 13-03</org_study_id>
    <nct_id>NCT02243358</nct_id>
  </id_info>
  <brief_title>Phase II Study of Chemo-Radiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer</brief_title>
  <official_title>A Neoadjuvant Phase II Study of Chemo-Radiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry Ford Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Henry Ford Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and effectiveness of a novel neoadjuvant treatment strategy&#xD;
      incorporating 5-fluorouracil/leucovorin with oxaliplatin ( FOLFOX )chemotherapy in&#xD;
      combination with chemo-radiation with gemcitabine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective is to evaluate frequency of achieving complete resection ( RO resection&#xD;
      )in patients with resectable and borderline resectable pancreatic cancer treated with a&#xD;
      neoadjuvant regimen of FOLFOX followed by radiation therapy (RT) concurrent with gemcitabine&#xD;
      chemotherapy at standard dosing.&#xD;
&#xD;
      Secondary objectives are to determine overall survival and progression-free survival as a&#xD;
      function of time from study enrollment and to evaluate tolerability and toxicity of protocol&#xD;
      treatment.&#xD;
&#xD;
      Eligible patients with resectable and borderline resectable pancreatic cancer will be accrued&#xD;
      onto protocol therapy, which would include a neo-adjuvant phase followed by surgical&#xD;
      resection. A cycle of FOLFOX treatment is 14 days. 2 cycles are intended prior to combined&#xD;
      modality treatment. Combined modality treatment will begin 2 weeks (plus or minus 2 days)&#xD;
      after the last FOLFOX administration. (Gemcitabine 1000mg/m² will be infused over 30 minutes&#xD;
      on days 1, 8, 22, and 29 during the 5-week course of radiation treatment. The surgical&#xD;
      procedure performed will be that required for a complete resection, and this will be based on&#xD;
      the discretion of the operating surgeon. Patients will be followed for 1 year after&#xD;
      completion of neoadjuvant therapy or until removal or termination from study, or until death,&#xD;
      whichever occurs first. Patients will be seen in follow-up ever 3+/- 1 months for 1 year from&#xD;
      completion of protocol therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2014</start_date>
  <primary_completion_date type="Anticipated">February 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>Primary Tumor Response</measure>
    <time_frame>6 weeks</time_frame>
    <description>Diagnostic imaging and RECIST criteria will be used to evaluate and record response of the primary tumor</description>
  </primary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Pancreas Neoplasm Malignant Resectable</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Folfox6</intervention_name>
    <other_name>5 Fluoropyrymidine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <other_name>Gemzar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation Therapy</intervention_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pancreaticoduodenectomy with retroperitoneal lymphadenectomy</intervention_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have histologically or cytologically confirmed pancreatic adenocarcinoma&#xD;
             of the pancreatic head or body&#xD;
&#xD;
          -  Patients must have radiographically-confirmed surgically resectable or borderline&#xD;
             resectable disease at study entry staged at T1-3, NO-1 and MO&#xD;
&#xD;
          -  Age &gt;/= 18years&#xD;
&#xD;
          -  Life expectancy of greater than 6 months in the opinion of the investigator, excluding&#xD;
             theh pancreatic cancer&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status &lt;/= 1&#xD;
&#xD;
          -  Required laboratory data (see protocol)&#xD;
&#xD;
          -  Disease assessment by CT scan within 4 weeks of study entry&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients may not be receiving any other investigational agent&#xD;
&#xD;
          -  Patients with metastatic disease are excluded from this clinical trial&#xD;
&#xD;
          -  History of allergic reactions attributed to Fluorouracil (5FU), oxaliplatin and&#xD;
             gemcitabine&#xD;
&#xD;
          -  No prior chemotherapy or radiation therapy for pancreatic cancer (previous&#xD;
             chemotherapy or radiation therapy for other malignancies is permitted)&#xD;
&#xD;
          -  Patients with uncontrolled hypocalcemia, hypomagnesemia, hyponatremia,&#xD;
             hypophosphatemia or hypokalemia defined as less than the lower limit of normal for the&#xD;
             institution, despite adequate electrolyte supplementation are excluded from this&#xD;
             study.&#xD;
&#xD;
          -  Uncontrolled serious intercurrent illness including, but not limited to, ongoing or&#xD;
             serious active infection requiring IV antibiotics for over 30 days, symptomatic&#xD;
             congestive heart failure, unstable angina pectoris, cardiac arrhythmia other than&#xD;
             chronic, stable atrial fibrillation, or psychiatric illness/social situations that&#xD;
             would limit compliance with study requirements&#xD;
&#xD;
          -  Pregnant or breastfeeding women are excluded from this study.&#xD;
&#xD;
          -  Known HIV-positive patients are ineligible&#xD;
&#xD;
          -  Patients with unresectable disease are excluded form the protocol (see Appendix B for&#xD;
             National Comprehensive cancer Network [NCCN] criteria for determining resectability&#xD;
             status). Surgical resectability must be confirmed by a surgeon experienced in&#xD;
             pancreatic surgery.&#xD;
&#xD;
          -  Patients with pancreatic tail lesions will be excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gazala Khan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Henry Ford Health System</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tiffany Pearce, BS</last_name>
    <phone>313-916-1784</phone>
    <email>tpearce1@hfhs.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jennifer Carabio, BS</last_name>
    <phone>313-916-1827</phone>
    <email>jcarabi1@hfhs.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tiffany Pearce, BS</last_name>
      <phone>313-916-1784</phone>
      <email>tpearce1@hfhs.org</email>
    </contact>
    <contact_backup>
      <last_name>Jennifer Carabio, BS</last_name>
      <phone>313-916-1827</phone>
      <email>jcarabi1@hfhs.org</email>
    </contact_backup>
    <investigator>
      <last_name>Gazala Kahn, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>October 13, 2016</last_update_submitted>
  <last_update_submitted_qc>October 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Henry Ford Health System</investigator_affiliation>
    <investigator_full_name>Gazala Khan, MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Pancreatic, cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gemcitabine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Through publication in peer reviewed journal</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>November 19, 2021</submitted>
    <returned>December 14, 2021</returned>
    <submitted>February 14, 2022</submitted>
    <returned>March 8, 2022</returned>
    <submitted>August 17, 2022</submitted>
    <returned>September 9, 2022</returned>
    <submitted>August 23, 2023</submitted>
    <returned>August 24, 2023</returned>
  </pending_results>
  <!-- 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/NCT02243358
org study id: HFHS 13-03
nct id: NCT02243358
lead sponsor: 
has dmc: No
To evaluate the safety and effectiveness of a novel neoadjuvant treatment strategy
      incorporating 5-fluorouracil/leucovorin with oxaliplatin ( FOLFOX )chemotherapy in
      combination with chemo-radiation with gemcitabine.
The primary objective is to evaluate frequency of achieving complete resection ( RO resection
      )in patients with resectable and borderline resectable pancreatic cancer treated with a
      neoadjuvant regimen of FOLFOX followed by radiation therapy (RT) concurrent with gemcitabine
      chemotherapy at standard dosing.

      Secondary objectives are to determine overall survival and progression-free survival as a
      function of time from study enrollment and to evaluate tolerability and toxicity of protocol
      treatment.

      Eligible patients with resectable and borderline resectable pancreatic cancer will be accrued
      onto protocol therapy, which would include a neo-adjuvant phase followed by surgical
      resection. A cycle of FOLFOX treatment is 14 days. 2 cycles are intended prior to combined
      modality treatment. Combined modality treatment will begin 2 weeks (plus or minus 2 days)
      after the last FOLFOX administration. (Gemcitabine 1000mg/m² will be infused over 30 minutes
      on days 1, 8, 22, and 29 during the 5-week course of radiation treatment. The surgical
      procedure performed will be that required for a complete resection, and this will be based on
      the discretion of the operating surgeon. Patients will be followed for 1 year after
      completion of neoadjuvant therapy or until removal or termination from study, or until death,
      whichever occurs first. Patients will be seen in follow-up ever 3+/- 1 months for 1 year from
      completion of protocol therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary Tumor Response
time frame: 6 weeks
description: Diagnostic imaging and RECIST criteria will be used to evaluate and record response of the primary tumor
intervention type: Drug
intervention name: Folfox6
other name: 5 Fluoropyrymidine
intervention type: Drug
intervention name: Gemcitabine
other name: Gemzar
intervention type: Radiation
intervention name: Radiation Therapy
intervention type: Procedure
intervention name: Pancreaticoduodenectomy with retroperitoneal lymphadenectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Gazala Khan, MD
role: Principal Investigator
affiliation: Henry Ford Health System
last name: Tiffany Pearce, BS
phone: 313-916-1784
email: tpearce1@hfhs.org
last name: Jennifer Carabio, BS
phone: 313-916-1827
email: jcarabi1@hfhs.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Henry Ford Health System
investigator full name: Gazala Khan, MD
investigator title: MD
mesh term: Pancreatic Neoplasms
mesh term: Neoplasms
mesh term: Gemcitabine
sharing ipd: Yes
ipd description: Through publication in peer reviewed journal
submitted: November 19, 2021
returned: December 14, 2021
submitted: February 14, 2022
returned: March 8, 2022
submitted: August 17, 2022
returned: September 9, 2022
submitted: August 23, 2023
returned: August 24, 2023