<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/NCT02241551</url>
  </required_header>
  <id_info>
    <org_study_id>UPCI 13-143</org_study_id>
    <nct_id>NCT02241551</nct_id>
  </id_info>
  <brief_title>Phase II Neoadjuvant Chemotheraphy (Gemcitabine and Nab-Paclitaxel vs. mFOLFIRINOX) and Sterotatic Body Radiation Therapy for Borderline Resectable Pancreatic Cancer</brief_title>
  <official_title>Phase II Study of Neoadjuvant Chemotheraphy (Gemcitabine and Nab-Paclitaxel vs. mFOLFIRINOX) and Sterotatic Body Radiation Therapy for Borderline Resectable Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nathan Bahary, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, randomized phase II trial. Patients diagnosed with borderline&#xD;
      resectable pancreatic adenocarcinoma will be randomly assigned to one of two treatment arms,&#xD;
      either mFOLFIRINOX or gemcitabine and nab-paclitaxel. After three cycles of treatment in the&#xD;
      gemcitabine/nab-paclitaxel arm and 6 cycles in the mFOLFIRINOX arm, patients will be restaged&#xD;
      with CT scans and if they remain borderline resectable or have improvement of their disease&#xD;
      They will then proceed to SBRT followed by surgical resection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study was terminated with the IRB ended early as logistical concerns of the SBRT&#xD;
  </why_stopped>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">March 3, 2017</completion_date>
  <primary_completion_date type="Actual">March 3, 2017</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>Safety and Efficacy Using Neo-adjuvant Gemcitabine Plus Nab-paclitaxel in Patients Receiving SBRT and Surgery for Borderline Resectable Pancreatic Cancer, Using Neo-adjuvant mFOLFIRINOX as a Control</measure>
    <time_frame>up to 5 years</time_frame>
    <description>Efficacy: pathological complete response (pCR) and R0 resection. Safety: Grade 4 toxicity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>R0 Resection Rates in Borderline Resectable Pancreatic Cancer</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Grade 3 and 4 Toxicities for the 2 Chemotherapy Regimens That Occur After Cycle 1 Day 1</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>According to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTAE, v4.0)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ca19-9 Response to Neoadjuvant Chemotherapy</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Disease Progression</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of Biomarkers (SPARC, RM1 and SMAD4) in Tissues</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>This wil be measured in tissues that are obtained at screening and in the resected tumour specimen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological Response Rate to Therapy</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Radiological improvements will be evaluated by determining changes in density of measurable disease on CT scan pre and post chemotherapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Effects of Chemotherapy on Patients Receiving Chemotherapy and SBRT</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>This will be measured using the FACT-HB questionaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Borderline Resectable Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>gemcitabine/nab-paclitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>three cycles of treatment in the gemcitabine/nab-paclitaxel</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mFOLFIRINOX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 cycles in the mFOLFIRINOX</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>gemcitabine/nab-paclitaxel</intervention_name>
    <description>three cycles of treatment in the gemcitabine/nab-paclitaxel</description>
    <arm_group_label>gemcitabine/nab-paclitaxel</arm_group_label>
    <other_name>Gemzar</other_name>
    <other_name>ABRAXANE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>mFOLFIRINOX</intervention_name>
    <description>6 cycles in the mFOLFIRINOX</description>
    <arm_group_label>mFOLFIRINOX</arm_group_label>
    <other_name>irinotecan</other_name>
    <other_name>fluorouracil</other_name>
    <other_name>oxaliplatin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All patients must meet the following criteria within 28 days of randomization (unless&#xD;
        otherwise indicated) to be enrolled in the protocol:&#xD;
&#xD;
          -  Histologically or cytologically proven adenocarcinoma of the pancreas. If the patient&#xD;
             has mixed tumor with predominant adenocarcinoma pathology, they can be enrolled.&#xD;
&#xD;
          -  Subjects will be staged according to the 2010 American Joint Committee on Cancer&#xD;
             (AJCC) staging system with pathologic stage T1-4, N0 being eligible; and have a&#xD;
             primary tumor of the pancreas (either pancreatic head, neck, uncinate process, or&#xD;
             body/tail)&#xD;
&#xD;
          -  The tumor must be deemed as being borderline resectable. Final CT confirmation of&#xD;
             surgical staging/ eligibility will be at the discretion of the pancreatic surgeon of&#xD;
             the patient.&#xD;
&#xD;
          -  Disease is confined to locoregional site as confirmed by the CT and / or diagnostic&#xD;
             staging laparoscopy to avoid occult peritoneal deposits. Diagnostic laproscopy will be&#xD;
             only if absolutely required&#xD;
&#xD;
          -  Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) on&#xD;
             imaging studies CT&#xD;
&#xD;
          -  Screening Endoscopic ultrasound if done prior to consent but within 6 weeks of&#xD;
             expected randomization date it may be used.&#xD;
&#xD;
          -  Karnofsky performance status greater than or equal to 70 or Eastern Cooperative&#xD;
             Oncology Group (ECOG) performance of 0-2.&#xD;
&#xD;
          -  Age &gt; 18&#xD;
&#xD;
          -  Estimated life expectance &gt; 12 weeks&#xD;
&#xD;
          -  If female patient is of child bearing potential, she must have a negative serum&#xD;
             pregnancy test (βhCG) documented up to 72hrs prior to administration of first study&#xD;
             drug&#xD;
&#xD;
          -  Patient has screening blood work performed which includes the following (should be&#xD;
             drawn ≤ 14 days prior to randomization)&#xD;
&#xD;
          -  absolute neutrophil count (ANC) &gt; 1.5 x 109/L&#xD;
&#xD;
          -  Platelet count ≥ 100000/mm3&#xD;
&#xD;
          -  Hemoglobin (HgB) ≥ 9g/dL&#xD;
&#xD;
          -  aspartate aminotransferase (AST),Alanine Aminotransferase (ALT)≤ 2.5 x upper limit of&#xD;
             normal (ULN) Total Bilirubin ≤ ULN&#xD;
&#xD;
          -  Serum Cr within normal limits (WNL)&#xD;
&#xD;
          -  Coagulation studies with Prothrombin Time and International Normalized Ratio (PT/INR)&#xD;
             and partial thromboplastin time (PTT) within normal limits (±15%). • Patient has a&#xD;
             urinalysis obtained (≤14 days prior to randomization) and the results are deemed not&#xD;
             clinically significant by the investigator.&#xD;
&#xD;
          -  Patient has no evidence of jaundice at the time of enrolment. If stent is required to&#xD;
             alleviate jaundice, it should be metallic. If patient has a previously placed stent&#xD;
             and this is plastic, this should be changed to metallic.&#xD;
&#xD;
          -  Patient's pain symptoms have remained stable with no adjustment to analgesics within 7&#xD;
             days prior to randomization. Patient must be able to swallow entreat medications with&#xD;
             no requirement for a feeding tube. Patient's must not have intractable nausea or&#xD;
             vomiting which prohibits the patient from oral medications&#xD;
&#xD;
          -  Diabetes must be controlled prior to enrollment&#xD;
&#xD;
          -  Disease must be encompassed in a reasonable SBRT &quot;portal&quot; as defined by the treating&#xD;
             radiation oncologist&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ineligible Histology including non-adenocarcinomas, adenosquamous carcinoma, islet&#xD;
             cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal&#xD;
             carcinomas, distal bile duct and ampullary carcinomas&#xD;
&#xD;
          -  Evidence of distant metastasis on upright chest x-ray, CT or other staging studies&#xD;
&#xD;
          -  Subjects with recurrent disease&#xD;
&#xD;
          -  Prior radiation therapy to the upper abdomen or liver at the discretion of the&#xD;
             treating radiation oncologist could impair delivery of the prescribed radiation&#xD;
             treatment&#xD;
&#xD;
          -  Prior chemotherapy&#xD;
&#xD;
          -  Subjects in their reproductive age who are breast feeding or have a positive pregnancy&#xD;
             test&#xD;
&#xD;
          -  Any co-morbid condition of sufficient severity to limit full compliance with the&#xD;
             protocol per assessment by the individual treating physician&#xD;
&#xD;
          -  Concurrent active infection&#xD;
&#xD;
          -  Previous or current malignancies of other histologies within the last 3 yrs prior to&#xD;
             randomization; with the exception of cervical cancer in situ, adequately treated basal&#xD;
             cell or squamous cell carcinoma of skin or treated low risk prostate cancer&#xD;
&#xD;
          -  Patient with known historical or active infection with HIV, Hepatitis B or Hepatitis C&#xD;
&#xD;
          -  Patient who has undergone recent major surgery, other than diagnostic surgical&#xD;
             procedure within 4 weeks prior to randomization.&#xD;
&#xD;
          -  Patient who has a history of allergy or hypersensitivity to any of the study drugs.&#xD;
&#xD;
          -  Patients with a history of interstitial lung disease, history of slowly progressive&#xD;
             dyspnea and unproductive cough, sarcoidosis, silicosis, interstitial pulmonary&#xD;
             fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies&#xD;
&#xD;
          -  Patients with greater than 2 screening peripheral neuropathy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hillman Cancer Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <results_first_submitted>March 5, 2018</results_first_submitted>
  <results_first_submitted_qc>May 15, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">June 15, 2018</results_first_posted>
  <last_update_submitted>June 30, 2018</last_update_submitted>
  <last_update_submitted_qc>June 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Nathan Bahary, MD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Borderline</keyword>
  <keyword>Resectable</keyword>
  <keyword>Pancreatic</keyword>
  <keyword>Cancer</keyword>
  <keyword>Neoadjuvant</keyword>
  <keyword>Chemotheraphy</keyword>
  <keyword>Gemcitabine</keyword>
  <keyword>Nab-Paclitaxel</keyword>
  <keyword>mFOFIRINOX</keyword>
  <keyword>Sterotatic Body Radiation Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</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>Fluorouracil</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Irinotecan</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 27, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT02241551/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Gemcitabine/Nab-paclitaxel</title>
          <description>Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel</description>
        </group>
        <group group_id="P2">
          <title>mFOLFIRINOX</title>
          <description>Patients that received 6 cycles in the mFOLFIRINOX</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The number of participants analyzed or is zero for the Treatment Arm in which zero participants were treated.</population>
      <group_list>
        <group group_id="B1">
          <title>Gemcitabine/Nab-paclitaxel</title>
          <description>Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel</description>
        </group>
        <group group_id="B2">
          <title>mFOLFIRINOX</title>
          <description>Patients that received 6 cycles in the mFOLFIRINOX</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="1"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="1"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54" lower_limit="54" upper_limit="54"/>
                    <measurement group_id="B3" value="54" lower_limit="54" upper_limit="54"/>
                  </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="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Safety and Efficacy Using Neo-adjuvant Gemcitabine Plus Nab-paclitaxel in Patients Receiving SBRT and Surgery for Borderline Resectable Pancreatic Cancer, Using Neo-adjuvant mFOLFIRINOX as a Control</title>
        <description>Efficacy: pathological complete response (pCR) and R0 resection. Safety: Grade 4 toxicity.</description>
        <time_frame>up to 5 years</time_frame>
        <population>Patient did not receive three cycles of treatment - data were not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Gemcitabine/Nab-paclitaxel</title>
            <description>Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel</description>
          </group>
          <group group_id="O2">
            <title>mFOLFIRINOX</title>
            <description>Patients that received 6 cycles in the mFOLFIRINOX</description>
          </group>
        </group_list>
        <measure>
          <title>Safety and Efficacy Using Neo-adjuvant Gemcitabine Plus Nab-paclitaxel in Patients Receiving SBRT and Surgery for Borderline Resectable Pancreatic Cancer, Using Neo-adjuvant mFOLFIRINOX as a Control</title>
          <description>Efficacy: pathological complete response (pCR) and R0 resection. Safety: Grade 4 toxicity.</description>
          <population>Patient did not receive three cycles of treatment - data were not collected.</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>R0 Resection Rates in Borderline Resectable Pancreatic Cancer</title>
        <time_frame>Up to 5 years</time_frame>
        <population>Patient did not receive three cycles of treatment - data were not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Gemcitabine/Nab-paclitaxel</title>
            <description>Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel</description>
          </group>
          <group group_id="O2">
            <title>mFOLFIRINOX</title>
            <description>Patients that received 6 cycles in the mFOLFIRINOX</description>
          </group>
        </group_list>
        <measure>
          <title>R0 Resection Rates in Borderline Resectable Pancreatic Cancer</title>
          <population>Patient did not receive three cycles of treatment - data were not collected.</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>Incidence of Grade 3 and 4 Toxicities for the 2 Chemotherapy Regimens That Occur After Cycle 1 Day 1</title>
        <description>According to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTAE, v4.0)</description>
        <time_frame>Up to 5 years</time_frame>
        <population>Patient was not treated - no data collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Gemcitabine/Nab-paclitaxel</title>
            <description>Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel</description>
          </group>
          <group group_id="O2">
            <title>mFOLFIRINOX</title>
            <description>Patients that received 6 cycles in the mFOLFIRINOX</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Grade 3 and 4 Toxicities for the 2 Chemotherapy Regimens That Occur After Cycle 1 Day 1</title>
          <description>According to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTAE, v4.0)</description>
          <population>Patient was not treated - no data collected.</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>Ca19-9 Response to Neoadjuvant Chemotherapy</title>
        <time_frame>Up to 5 years</time_frame>
        <population>Patient did not receive three cycles of treatment - data were not collected / zero total participants were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Gemcitabine/Nab-paclitaxel</title>
            <description>three cycles of treatment in the gemcitabine/nab-paclitaxel&#xD;
gemcitabine/nab-paclitaxel: three cycles of treatment in the gemcitabine/nab-paclitaxel</description>
          </group>
          <group group_id="O2">
            <title>mFOLFIRINOX</title>
            <description>6 cycles in the mFOLFIRINOX&#xD;
mFOLFIRINOX: 6 cycles in the mFOLFIRINOX</description>
          </group>
        </group_list>
        <measure>
          <title>Ca19-9 Response to Neoadjuvant Chemotherapy</title>
          <population>Patient did not receive three cycles of treatment - data were not collected / zero total participants were analyzed.</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>Time to Disease Progression</title>
        <time_frame>Up to 5 years</time_frame>
        <population>Patient did not receive three cycles of treatment - data not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Gemcitabine/Nab-paclitaxel</title>
            <description>Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel</description>
          </group>
          <group group_id="O2">
            <title>mFOLFIRINOX</title>
            <description>Patients that received 6 cycles in the mFOLFIRINOX</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Disease Progression</title>
          <population>Patient did not receive three cycles of treatment - data not collected.</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>Measurement of Biomarkers (SPARC, RM1 and SMAD4) in Tissues</title>
        <description>This wil be measured in tissues that are obtained at screening and in the resected tumour specimen</description>
        <time_frame>Up to 5 years</time_frame>
        <population>Patient did not receive three cycles of treatment - data not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Gemcitabine/Nab-paclitaxel</title>
            <description>Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel</description>
          </group>
          <group group_id="O2">
            <title>mFOLFIRINOX</title>
            <description>Patients that received 6 cycles in the mFOLFIRINOX</description>
          </group>
        </group_list>
        <measure>
          <title>Measurement of Biomarkers (SPARC, RM1 and SMAD4) in Tissues</title>
          <description>This wil be measured in tissues that are obtained at screening and in the resected tumour specimen</description>
          <population>Patient did not receive three cycles of treatment - data not collected.</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>Radiological Response Rate to Therapy</title>
        <description>Radiological improvements will be evaluated by determining changes in density of measurable disease on CT scan pre and post chemotherapy</description>
        <time_frame>Up to 5 years</time_frame>
        <population>Patient did not receive three cycles of treatment - data not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Gemcitabine/Nab-paclitaxel</title>
            <description>Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel</description>
          </group>
          <group group_id="O2">
            <title>mFOLFIRINOX</title>
            <description>Patients that received 6 cycles in the mFOLFIRINOX</description>
          </group>
        </group_list>
        <measure>
          <title>Radiological Response Rate to Therapy</title>
          <description>Radiological improvements will be evaluated by determining changes in density of measurable disease on CT scan pre and post chemotherapy</description>
          <population>Patient did not receive three cycles of treatment - data not collected.</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>Quality of Life Effects of Chemotherapy on Patients Receiving Chemotherapy and SBRT</title>
        <description>This will be measured using the FACT-HB questionaire</description>
        <time_frame>Up to 5 years</time_frame>
        <population>Patient did not receive three cycles of treatment - data not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Gemcitabine/Nab-paclitaxel</title>
            <description>three cycles of treatment in the gemcitabine/nab-paclitaxel&#xD;
gemcitabine/nab-paclitaxel: three cycles of treatment in the gemcitabine/nab-paclitaxel</description>
          </group>
          <group group_id="O2">
            <title>mFOLFIRINOX</title>
            <description>6 cycles in the mFOLFIRINOX&#xD;
mFOLFIRINOX: 6 cycles in the mFOLFIRINOX</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life Effects of Chemotherapy on Patients Receiving Chemotherapy and SBRT</title>
          <description>This will be measured using the FACT-HB questionaire</description>
          <population>Patient did not receive three cycles of treatment - data not collected.</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_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <desc>The number of participants at risk for Serious Adverse Events is zero for the Treatment Arm in which zero participants were treated.&#xD;
The number of participants at risk for Other (Not Including Serious) Adverse Events is zero for the Treatment Arm in which zero participants were treated.&#xD;
The number of participants at risk for All-Cause Mortality is zero for the Treatment Arm in which zero participants were treated.</desc>
      <group_list>
        <group group_id="E1">
          <title>Gemcitabine/Nab-paclitaxel</title>
          <description>Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel</description>
        </group>
        <group group_id="E2">
          <title>mFOLFIRINOX</title>
          <description>Patients that received 6 cycles in the mFOLFIRINOX</description>
        </group>
      </group_list>
      <serious_events>
        <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="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>Nathan Bahary, MD</name_or_title>
      <organization>University of Pittsburgh Cancer Institute</organization>
      <phone>412-864-7764</phone>
      <email>baharyn@upmc.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/NCT02241551
org study id: UPCI 13-143
nct id: NCT02241551
lead sponsor: 
has dmc: Yes
This is a prospective, randomized phase II trial. Patients diagnosed with borderline
      resectable pancreatic adenocarcinoma will be randomly assigned to one of two treatment arms,
      either mFOLFIRINOX or gemcitabine and nab-paclitaxel. After three cycles of treatment in the
      gemcitabine/nab-paclitaxel arm and 6 cycles in the mFOLFIRINOX arm, patients will be restaged
      with CT scans and if they remain borderline resectable or have improvement of their disease
      They will then proceed to SBRT followed by surgical resection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and Efficacy Using Neo-adjuvant Gemcitabine Plus Nab-paclitaxel in Patients Receiving SBRT and Surgery for Borderline Resectable Pancreatic Cancer, Using Neo-adjuvant mFOLFIRINOX as a Control
time frame: up to 5 years
description: Efficacy: pathological complete response (pCR) and R0 resection. Safety: Grade 4 toxicity.
measure: R0 Resection Rates in Borderline Resectable Pancreatic Cancer
time frame: Up to 5 years
measure: Incidence of Grade 3 and 4 Toxicities for the 2 Chemotherapy Regimens That Occur After Cycle 1 Day 1
time frame: Up to 5 years
description: According to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTAE, v4.0)
measure: Ca19-9 Response to Neoadjuvant Chemotherapy
time frame: Up to 5 years
measure: Time to Disease Progression
time frame: Up to 5 years
measure: Measurement of Biomarkers (SPARC, RM1 and SMAD4) in Tissues
time frame: Up to 5 years
description: This wil be measured in tissues that are obtained at screening and in the resected tumour specimen
measure: Radiological Response Rate to Therapy
time frame: Up to 5 years
description: Radiological improvements will be evaluated by determining changes in density of measurable disease on CT scan pre and post chemotherapy
measure: Quality of Life Effects of Chemotherapy on Patients Receiving Chemotherapy and SBRT
time frame: Up to 5 years
description: This will be measured using the FACT-HB questionaire
arm group label: gemcitabine/nab-paclitaxel
arm group type: Experimental
description: three cycles of treatment in the gemcitabine/nab-paclitaxel
arm group label: mFOLFIRINOX
arm group type: Experimental
description: 6 cycles in the mFOLFIRINOX
intervention type: Drug
intervention name: gemcitabine/nab-paclitaxel
description: three cycles of treatment in the gemcitabine/nab-paclitaxel
arm group label: gemcitabine/nab-paclitaxel
other name: Gemzar
other name: ABRAXANE
intervention type: Drug
intervention name: mFOLFIRINOX
description: 6 cycles in the mFOLFIRINOX
arm group label: mFOLFIRINOX
other name: irinotecan
other name: fluorouracil
other name: oxaliplatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Nathan Bahary, MD
investigator title: Associate Professor
mesh term: Pancreatic Neoplasms
mesh term: Paclitaxel
mesh term: Gemcitabine
mesh term: Fluorouracil
mesh term: Oxaliplatin
mesh term: Irinotecan
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 