<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/NCT02243007</url>
  </required_header>
  <id_info>
    <org_study_id>14-218</org_study_id>
    <nct_id>NCT02243007</nct_id>
  </id_info>
  <brief_title>Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer</brief_title>
  <official_title>Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is a Phase II clinical trial, which evaluates a combination of drugs,&#xD;
      FOLFIRINOX and Gemcitabine/Nab-Paclitaxel, in the management of participants with resectable&#xD;
      pancreatic cancer prior to surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who fulfill eligibility criteria will be randomized to Arm A or Arm B&#xD;
&#xD;
        -  Treatment will be administered on an outpatient basis.&#xD;
&#xD;
        -  Upon registration participants will be randomized to Arm A (FOLFIRINOX) or Arm B&#xD;
           (Gemcitabine/nab-Paclitaxel).&#xD;
&#xD;
        -  After completion of FOLFIRINOX or Gemcitabine/Nab-paclitaxel, all participants without&#xD;
           progressive disease will proceed to radiation therapy with capecitabine .&#xD;
&#xD;
        -  Between 2 and 4 weeks after radiation is complete, participants will proceed for&#xD;
           surgical resection of pancreatic cancer&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow Accrual&#xD;
  </why_stopped>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <phase>Phase 2</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>Survival Rate at 18 Month</measure>
    <time_frame>18 Month</time_frame>
    <description>Number of participants surviving after 18 months of study follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pathologic Complete Response Rate (pCR).</measure>
    <time_frame>18 Months</time_frame>
    <description>Number of patients achieving pathologic complete response at 18 months. Pathologic complete response is defined as the absence of residual invasive disease in the panaceas and in the regional lymph nodes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival Rate</measure>
    <time_frame>Baseline, 5 Years</time_frame>
    <description>Overall survival rate at five years using Kaplan-Meier survival analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Serious and Non-Serious Adverse Events</measure>
    <time_frame>Baseline, 28 Days</time_frame>
    <description>Number of Participants with Serious and Non-Serious Adverse Events from baseline to 28 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical Morbidity Rate</measure>
    <time_frame>within 30 days of surgery</time_frame>
    <description>Number of patients experiencing a specific surgery related morbidity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day Post-operative Mortality Rate</measure>
    <time_frame>30 Days</time_frame>
    <description>Number of patients who died following surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of Biomarkers With PFS</measure>
    <time_frame>2 Years</time_frame>
    <description>Analysis of the correlation between selected bio-markers and progression free survival.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Pathologic Downstaging</measure>
    <time_frame>2 Years</time_frame>
    <description>The number of participants achieving a reduction in the pathological staging of the primary cancer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local Control Rate</measure>
    <time_frame>2 Years</time_frame>
    <description>The number of participants achieving local control. The local control rate is defined as the number of participants achieving stable disease, partial response, or a complete response.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Resectable Pancreatic Cancer</condition>
  <condition>Pancreatic Ductal Carcinoma</condition>
  <arm_group>
    <arm_group_label>Folfirinox-ARM A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel&#xD;
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.&#xD;
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gemcitabine/nab-Paclitaxel- Arm B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).&#xD;
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.&#xD;
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FOLFIRINOX</intervention_name>
    <arm_group_label>Folfirinox-ARM A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine/nab-Paclitaxel</intervention_name>
    <arm_group_label>Gemcitabine/nab-Paclitaxel- Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation therapy</intervention_name>
    <arm_group_label>Folfirinox-ARM A</arm_group_label>
    <arm_group_label>Gemcitabine/nab-Paclitaxel- Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <arm_group_label>Folfirinox-ARM A</arm_group_label>
    <arm_group_label>Gemcitabine/nab-Paclitaxel- Arm B</arm_group_label>
    <other_name>Xeloda</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cytologic or histologic proof of pancreatic ductal carcinoma is required prior to&#xD;
             study entry.&#xD;
&#xD;
          -  No evidence of metastatic disease as determined by chest CT scan, and abdominal CT&#xD;
             scan (or MRI with gadolinium and/or manganese) and laparoscopy. All patients must be&#xD;
             staged with a physical exam, chest CT, abdominal CT with intravenous contrast (or&#xD;
             abdominal MRI with gadolinium and/or manganese). Only potentially resectable patients&#xD;
             are eligible. Potentially resectable is defined as a) no extrapancreatic disease, b)&#xD;
             no evidence (on CT) of involvement of the celiac axis or SMA, c) no evidence (CT or&#xD;
             MRI) of occlusion of the SMV or SMPV confluence, and d) no evidence of gross&#xD;
             peritoneal or distant metastases by laparoscopy.&#xD;
&#xD;
          -  Patients must be 18 years old or older. There will be no upper age restriction.&#xD;
&#xD;
          -  ECOG Performance Status of 0 or 1 are eligible.&#xD;
&#xD;
          -  Life expectancy of greater than 3 months.&#xD;
&#xD;
          -  Lab Values:&#xD;
&#xD;
               -  ANC ≥ 1500 cells/mm3&#xD;
&#xD;
               -  Platelet count at least 100,000 cells/mm3.&#xD;
&#xD;
               -  AST and ALT ≤2.5 x upper limit of normal&#xD;
&#xD;
               -  Total Bilirubin ≤ 5 x upper limit of normal if patient is s/p biliary stenting&#xD;
                  AND decreasing at least two time points after stenting.&#xD;
&#xD;
               -  Total Bilirubin ≤ 1.5 x upper limit of normal if no biliary stenting was done&#xD;
&#xD;
               -  Serum Creatinine ≤1.5mg/dl OR&#xD;
&#xD;
               -  Creatinine Clearance greater than or equal to 30ml/min (as estimated by Cockroft&#xD;
                  Gault Equation) (140 - age [yrs]) (body wt [kg])&#xD;
&#xD;
                    -  Creatinine clearance for males = ------------ (72) (serum creatinine&#xD;
                       [mg/dL])&#xD;
&#xD;
                    -  Creatinine clearance for females = 0.85 x male value&#xD;
&#xD;
          -  The effects of radiation on the developing human fetus are known to be teratogenic.&#xD;
             Women of child-bearing potential and men must agree to use adequate contraception&#xD;
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for&#xD;
             the duration of study treatment plus 30 days from the last date of study drug&#xD;
             administration. Should a woman become pregnant or suspect she is pregnant while&#xD;
             participating in this study, she should inform her treating physician immediately.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who fulfill any of the following criteria will be excluded:&#xD;
&#xD;
          -  The presence of metastatic disease on imaging or laparoscopy.&#xD;
&#xD;
          -  Serious concomitant systemic disorders incompatible with the study (at the discretion&#xD;
             of the investigator), such as significant cardiac or pulmonary morbidity e.g.&#xD;
             congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias&#xD;
             not well controlled with medication) or myocardial infarction within the last 12&#xD;
             months, ongoing infection as manifested by fever.&#xD;
&#xD;
          -  Pregnant or lactating women. Women of childbearing potential with either a positive or&#xD;
             no pregnancy test (serum or urine) at baseline. (Postmenopausal woman must have been&#xD;
             amenorrheic for at least 12 months to be considered of non-childbearing potential).&#xD;
&#xD;
          -  Any prior chemotherapy or radiation for treatment of the patient's pancreatic tumor.&#xD;
&#xD;
          -  Diagnosis for other invasive carcinomas (except basal cell carcinoma/squamous cell&#xD;
             carcinoma of the skin) within the last five years. Carcinoma in-situ is allowed.&#xD;
&#xD;
          -  Other serious uncontrolled medical conditions that the investigator feels might&#xD;
             compromise study participation.&#xD;
&#xD;
          -  Unwillingness to participate or inability to comply with the protocol for the duration&#xD;
             of the study.&#xD;
&#xD;
          -  Participation in any investigational drug study within 4 weeks preceding the start of&#xD;
             study treatment.&#xD;
&#xD;
          -  History of uncontrolled seizures, central nervous system disorders or psychiatric&#xD;
             disability judged by the investigator to be clinically significant, precluding&#xD;
             informed consent, or interfering with compliance or oral drug intake.&#xD;
&#xD;
          -  Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment,&#xD;
             without complete recovery.&#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_official>
    <last_name>David Ryan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <results_first_submitted>November 16, 2016</results_first_submitted>
  <results_first_submitted_qc>April 10, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 16, 2017</results_first_posted>
  <last_update_submitted>April 10, 2017</last_update_submitted>
  <last_update_submitted_qc>April 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>David Patrick Ryan, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Resectable pancreatic cancer</keyword>
  <keyword>Pancreatic Ductal Carcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ductal</mesh_term>
    <mesh_term>Carcinoma, Pancreatic Ductal</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Folfirinox</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Folfirinox-ARM A</title>
          <description>Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel&#xD;
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.&#xD;
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer&#xD;
FOLFIRINOX&#xD;
Radiation therapy&#xD;
Capecitabine</description>
        </group>
        <group group_id="P2">
          <title>Gemcitabine/Nab-Paclitaxel- Arm B</title>
          <description>Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).&#xD;
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.&#xD;
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer&#xD;
Gemcitabine/nab-Paclitaxel&#xD;
Radiation therapy&#xD;
Capecitabine</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Folfirinox-ARM A</title>
          <description>Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel&#xD;
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.&#xD;
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer&#xD;
FOLFIRINOX&#xD;
Radiation therapy&#xD;
Capecitabine</description>
        </group>
        <group group_id="B2">
          <title>Gemcitabine/Nab-Paclitaxel- Arm B</title>
          <description>Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).&#xD;
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.&#xD;
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer&#xD;
Gemcitabine/nab-Paclitaxel&#xD;
Radiation therapy&#xD;
Capecitabine</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="7"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.4" lower_limit="49.4" upper_limit="68.3"/>
                    <measurement group_id="B2" value="71.9" lower_limit="59.9" upper_limit="74.1"/>
                    <measurement group_id="B3" value="65.6" lower_limit="49.4" upper_limit="74.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Survival Rate at 18 Month</title>
        <description>Number of participants surviving after 18 months of study follow-up</description>
        <time_frame>18 Month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Folfirinox-ARM A</title>
            <description>Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel&#xD;
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.&#xD;
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer&#xD;
FOLFIRINOX&#xD;
Radiation therapy&#xD;
Capecitabine</description>
          </group>
          <group group_id="O2">
            <title>Gemcitabine/Nab-Paclitaxel- Arm B</title>
            <description>Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).&#xD;
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.&#xD;
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer&#xD;
Gemcitabine/nab-Paclitaxel&#xD;
Radiation therapy&#xD;
Capecitabine</description>
          </group>
        </group_list>
        <measure>
          <title>Survival Rate at 18 Month</title>
          <description>Number of participants surviving after 18 months of study follow-up</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pathologic Complete Response Rate (pCR).</title>
        <description>Number of patients achieving pathologic complete response at 18 months. Pathologic complete response is defined as the absence of residual invasive disease in the panaceas and in the regional lymph nodes.</description>
        <time_frame>18 Months</time_frame>
        <population>No Data available. Study terminated before any patients reached 18 months of follow-up. Patients were not able to be evaluated for response.</population>
        <group_list>
          <group group_id="O1">
            <title>Folfirinox-ARM A</title>
            <description>Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel&#xD;
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.&#xD;
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer&#xD;
FOLFIRINOX&#xD;
Radiation therapy&#xD;
Capecitabine</description>
          </group>
          <group group_id="O2">
            <title>Gemcitabine/Nab-Paclitaxel- Arm B</title>
            <description>Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).&#xD;
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.&#xD;
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer&#xD;
Gemcitabine/nab-Paclitaxel&#xD;
Radiation therapy&#xD;
Capecitabine</description>
          </group>
        </group_list>
        <measure>
          <title>Pathologic Complete Response Rate (pCR).</title>
          <description>Number of patients achieving pathologic complete response at 18 months. Pathologic complete response is defined as the absence of residual invasive disease in the panaceas and in the regional lymph nodes.</description>
          <population>No Data available. Study terminated before any patients reached 18 months of follow-up. Patients were not able to be evaluated for response.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival Rate</title>
        <description>Overall survival rate at five years using Kaplan-Meier survival analysis</description>
        <time_frame>Baseline, 5 Years</time_frame>
        <population>Study terminated before endpoint was reached, no data available</population>
        <group_list>
          <group group_id="O1">
            <title>Folfirinox-ARM A</title>
            <description>Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel&#xD;
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.&#xD;
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer&#xD;
FOLFIRINOX&#xD;
Radiation therapy&#xD;
Capecitabine</description>
          </group>
          <group group_id="O2">
            <title>Gemcitabine/Nab-Paclitaxel- Arm B</title>
            <description>Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).&#xD;
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.&#xD;
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer&#xD;
Gemcitabine/nab-Paclitaxel&#xD;
Radiation therapy&#xD;
Capecitabine</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival Rate</title>
          <description>Overall survival rate at five years using Kaplan-Meier survival analysis</description>
          <population>Study terminated before endpoint was reached, no data available</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Serious and Non-Serious Adverse Events</title>
        <description>Number of Participants with Serious and Non-Serious Adverse Events from baseline to 28 days</description>
        <time_frame>Baseline, 28 Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Folfirinox-ARM A</title>
            <description>Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel&#xD;
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.&#xD;
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer&#xD;
FOLFIRINOX&#xD;
Radiation therapy&#xD;
Capecitabine</description>
          </group>
          <group group_id="O2">
            <title>Gemcitabine/Nab-Paclitaxel- Arm B</title>
            <description>Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).&#xD;
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.&#xD;
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer&#xD;
Gemcitabine/nab-Paclitaxel&#xD;
Radiation therapy&#xD;
Capecitabine</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious and Non-Serious Adverse Events</title>
          <description>Number of Participants with Serious and Non-Serious Adverse Events from baseline to 28 days</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serious Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Surgical Morbidity Rate</title>
        <description>Number of patients experiencing a specific surgery related morbidity</description>
        <time_frame>within 30 days of surgery</time_frame>
        <population>Study ended prematurely, no results available</population>
        <group_list>
          <group group_id="O1">
            <title>Folfirinox-ARM A</title>
            <description>Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel&#xD;
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.&#xD;
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer&#xD;
FOLFIRINOX&#xD;
Radiation therapy&#xD;
Capecitabine</description>
          </group>
          <group group_id="O2">
            <title>Gemcitabine/Nab-Paclitaxel- Arm B</title>
            <description>Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).&#xD;
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.&#xD;
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer&#xD;
Gemcitabine/nab-Paclitaxel&#xD;
Radiation therapy&#xD;
Capecitabine</description>
          </group>
        </group_list>
        <measure>
          <title>Surgical Morbidity Rate</title>
          <description>Number of patients experiencing a specific surgery related morbidity</description>
          <population>Study ended prematurely, no results available</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>30-day Post-operative Mortality Rate</title>
        <description>Number of patients who died following surgery.</description>
        <time_frame>30 Days</time_frame>
        <population>Study ended prematurely, no results available</population>
        <group_list>
          <group group_id="O1">
            <title>Folfirinox-ARM A</title>
            <description>Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel&#xD;
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.&#xD;
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer&#xD;
FOLFIRINOX&#xD;
Radiation therapy&#xD;
Capecitabine</description>
          </group>
          <group group_id="O2">
            <title>Gemcitabine/Nab-Paclitaxel- Arm B</title>
            <description>Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).&#xD;
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.&#xD;
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer&#xD;
Gemcitabine/nab-Paclitaxel&#xD;
Radiation therapy&#xD;
Capecitabine</description>
          </group>
        </group_list>
        <measure>
          <title>30-day Post-operative Mortality Rate</title>
          <description>Number of patients who died following surgery.</description>
          <population>Study ended prematurely, no results available</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation of Biomarkers With PFS</title>
        <description>Analysis of the correlation between selected bio-markers and progression free survival.</description>
        <time_frame>2 Years</time_frame>
        <population>Data not available. Study was terminated before endpoint was able to be evaluated</population>
        <group_list>
          <group group_id="O1">
            <title>Folfirinox-ARM A</title>
            <description>Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel&#xD;
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.&#xD;
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer&#xD;
FOLFIRINOX&#xD;
Radiation therapy&#xD;
Capecitabine</description>
          </group>
          <group group_id="O2">
            <title>Gemcitabine/Nab-Paclitaxel- Arm B</title>
            <description>Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).&#xD;
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.&#xD;
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer&#xD;
Gemcitabine/nab-Paclitaxel&#xD;
Radiation therapy&#xD;
Capecitabine</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation of Biomarkers With PFS</title>
          <description>Analysis of the correlation between selected bio-markers and progression free survival.</description>
          <population>Data not available. Study was terminated before endpoint was able to be evaluated</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Pathologic Downstaging</title>
        <description>The number of participants achieving a reduction in the pathological staging of the primary cancer.</description>
        <time_frame>2 Years</time_frame>
        <population>Data not available. Study was terminated before endpoint was able to be evaluated</population>
        <group_list>
          <group group_id="O1">
            <title>Folfirinox-ARM A</title>
            <description>Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel&#xD;
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.&#xD;
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer&#xD;
FOLFIRINOX&#xD;
Radiation therapy&#xD;
Capecitabine</description>
          </group>
          <group group_id="O2">
            <title>Gemcitabine/Nab-Paclitaxel- Arm B</title>
            <description>Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).&#xD;
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.&#xD;
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer&#xD;
Gemcitabine/nab-Paclitaxel&#xD;
Radiation therapy&#xD;
Capecitabine</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Pathologic Downstaging</title>
          <description>The number of participants achieving a reduction in the pathological staging of the primary cancer.</description>
          <population>Data not available. Study was terminated before endpoint was able to be evaluated</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Local Control Rate</title>
        <description>The number of participants achieving local control. The local control rate is defined as the number of participants achieving stable disease, partial response, or a complete response.</description>
        <time_frame>2 Years</time_frame>
        <population>Data not available. Study was terminated before endpoint was able to be evaluated</population>
        <group_list>
          <group group_id="O1">
            <title>Folfirinox-ARM A</title>
            <description>Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel&#xD;
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.&#xD;
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer&#xD;
FOLFIRINOX&#xD;
Radiation therapy&#xD;
Capecitabine</description>
          </group>
          <group group_id="O2">
            <title>Gemcitabine/Nab-Paclitaxel- Arm B</title>
            <description>Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).&#xD;
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.&#xD;
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer&#xD;
Gemcitabine/nab-Paclitaxel&#xD;
Radiation therapy&#xD;
Capecitabine</description>
          </group>
        </group_list>
        <measure>
          <title>Local Control Rate</title>
          <description>The number of participants achieving local control. The local control rate is defined as the number of participants achieving stable disease, partial response, or a complete response.</description>
          <population>Data not available. Study was terminated before endpoint was able to be evaluated</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Toxicity was assessed on day 1 of each cycle for the FOLFIRINOX arm and on Day 1, 8, 15 of each cycle for the Gem/Nab-P arm while being treated. Toxicity was assessed weekly during neoadjuvant radiation treatment and Capecitabine. Toxicity was planned to be assessed every 6 months during the first 3 years of post treatment follow-up.</time_frame>
      <desc>Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.</desc>
      <group_list>
        <group group_id="E1">
          <title>Folfirinox-ARM A</title>
          <description>Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel&#xD;
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.&#xD;
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer&#xD;
FOLFIRINOX&#xD;
Radiation therapy&#xD;
Capecitabine</description>
        </group>
        <group group_id="E2">
          <title>Gemcitabine/Nab-Paclitaxel- Arm B</title>
          <description>Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).&#xD;
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.&#xD;
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine&#xD;
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer&#xD;
Gemcitabine/nab-Paclitaxel&#xD;
Radiation therapy&#xD;
Capecitabine</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hemolytic uremic syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Eye disorders - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Optic nerve disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hemorrhoids</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Malabsorption</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Mucositis oral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E2" events="6" subjects_affected="2" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Edema limbs</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infections and infestations - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Bruising</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Muscle weakness lower limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorder - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Dysesthesia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Dysphasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Peripheral motor neuropathy</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Spasticity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal and urinary disorders - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Urine discoloration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Sore throat</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Skin/subcutaneous tissue disorders; Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>David P. Ryan, MD</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>6177240245</phone>
      <email>dpryan@mgh.harvard.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02243007
org study id: 14-218
nct id: NCT02243007
lead sponsor: 
has dmc: Yes
This research study is a Phase II clinical trial, which evaluates a combination of drugs,
      FOLFIRINOX and Gemcitabine/Nab-Paclitaxel, in the management of participants with resectable
      pancreatic cancer prior to surgery.
Patients who fulfill eligibility criteria will be randomized to Arm A or Arm B

        -  Treatment will be administered on an outpatient basis.

        -  Upon registration participants will be randomized to Arm A (FOLFIRINOX) or Arm B
           (Gemcitabine/nab-Paclitaxel).

        -  After completion of FOLFIRINOX or Gemcitabine/Nab-paclitaxel, all participants without
           progressive disease will proceed to radiation therapy with capecitabine .

        -  Between 2 and 4 weeks after radiation is complete, participants will proceed for
           surgical resection of pancreatic cancer
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Survival Rate at 18 Month
time frame: 18 Month
description: Number of participants surviving after 18 months of study follow-up
measure: Pathologic Complete Response Rate (pCR).
time frame: 18 Months
description: Number of patients achieving pathologic complete response at 18 months. Pathologic complete response is defined as the absence of residual invasive disease in the panaceas and in the regional lymph nodes.
measure: Overall Survival Rate
time frame: Baseline, 5 Years
description: Overall survival rate at five years using Kaplan-Meier survival analysis
measure: Number of Participants With Serious and Non-Serious Adverse Events
time frame: Baseline, 28 Days
description: Number of Participants with Serious and Non-Serious Adverse Events from baseline to 28 days
measure: Surgical Morbidity Rate
time frame: within 30 days of surgery
description: Number of patients experiencing a specific surgery related morbidity
measure: 30-day Post-operative Mortality Rate
time frame: 30 Days
description: Number of patients who died following surgery.
measure: Correlation of Biomarkers With PFS
time frame: 2 Years
description: Analysis of the correlation between selected bio-markers and progression free survival.
measure: Rate of Pathologic Downstaging
time frame: 2 Years
description: The number of participants achieving a reduction in the pathological staging of the primary cancer.
measure: Local Control Rate
time frame: 2 Years
description: The number of participants achieving local control. The local control rate is defined as the number of participants achieving stable disease, partial response, or a complete response.
arm group label: Folfirinox-ARM A
arm group type: Experimental
description: Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
arm group label: Gemcitabine/nab-Paclitaxel- Arm B
arm group type: Experimental
description: Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
intervention type: Drug
intervention name: FOLFIRINOX
arm group label: Folfirinox-ARM A
intervention type: Drug
intervention name: Gemcitabine/nab-Paclitaxel
arm group label: Gemcitabine/nab-Paclitaxel- Arm B
intervention type: Radiation
intervention name: Radiation therapy
arm group label: Folfirinox-ARM A
arm group label: Gemcitabine/nab-Paclitaxel- Arm B
intervention type: Drug
intervention name: Capecitabine
arm group label: Folfirinox-ARM A
arm group label: Gemcitabine/nab-Paclitaxel- Arm B
other name: Xeloda
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Ryan, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: David Patrick Ryan, MD
investigator title: Principal Investigator
mesh term: Pancreatic Neoplasms
mesh term: Carcinoma, Ductal
mesh term: Carcinoma, Pancreatic Ductal
mesh term: Paclitaxel
mesh term: Gemcitabine
mesh term: Capecitabine
mesh term: Folfirinox
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 