<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/NCT01726582</url>
  </required_header>
  <id_info>
    <org_study_id>MCW 15565</org_study_id>
    <secondary_id>Advancing a Healthier WI</secondary_id>
    <secondary_id>FP 7718</secondary_id>
    <nct_id>NCT01726582</nct_id>
  </id_info>
  <brief_title>Pancreas Cancer: Molecular Profiling as a Guide to Therapy Before and After Surgery (&quot;Personalized Medicine&quot;)</brief_title>
  <official_title>A Prospective Phase II Trial of Molecular Profiling to Guide Neoadjuvant Therapy for Resectable and Borderline Resectable Adenocarcinoma of the Pancreas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical College of Wisconsin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Cincinnati</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical College of Wisconsin</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this clinical trial, if the doctor knows or suspects that a growth in the pancreas is&#xD;
      cancer (adenocarcinoma), then a sample of the growth is tested (the test is called molecular&#xD;
      profiling). The results of the test are used by the doctor to recommend therapy (chemotherapy&#xD;
      and radiation therapy) that the patient will receive before having surgery to remove the&#xD;
      adenocarcinoma. When the patient goes to surgery, the adenocarcinoma that is removed is&#xD;
      tested again. The results of that test are used to guide the choice of therapy after surgery.&#xD;
&#xD;
      The chemotherapy drugs and the radiation therapy used in this clinical trial are already&#xD;
      approved for treatment of pancreas cancer. This trial is intended to establish which&#xD;
      treatment is best for a specific patient, based on test results from that patient's actual&#xD;
      adenocarcinoma. In the past, the decision as to which treatment the patient will receive was&#xD;
      not based on testing of the actual adenocarcinoma.&#xD;
&#xD;
      See treatment pathways at http://www.mcw.edu/surgery/patientinfo/Pancreatic-Cancer-Trial.htm.&#xD;
&#xD;
      Hypothesis: Resectability rate, overall survival rate and progression-free survival in&#xD;
      subjects with adenocarcinoma of the pancreas will be superior for who receive targeted&#xD;
      &quot;personalized&quot; therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">April 11, 2022</completion_date>
  <primary_completion_date type="Actual">June 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Subjects Completing Therapy Including Surgical Resection.</measure>
    <time_frame>At time of surgery (approximately 10 to 20 weeks after screening)</time_frame>
    <description>This outcome measure is the number of subjects completing therapy up to and including surgical resection. In this context, surgical excision of residual tumor is an option in the progression of usual care. Surgery was contraindicated for some participants. This measure is the number of subject who were eligible for and completed the surgical procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival in Months</measure>
    <time_frame>5 years</time_frame>
    <description>This measure is the median time of survival (in months) at five years from the initiation of therapy. Results will be presented for two cohorts: subjects completing neoadjuvant therapy and surgical resection; and subjects completing neoadjuvant therapy but without surgical resection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival</measure>
    <time_frame>5 years</time_frame>
    <description>This measure is the number of subjects not experiencing tumor progression at five years from initiating therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Biomarkers to Determine Course of Treatment</measure>
    <time_frame>Initiation of therapy (approximately 4 to 12 weeks after screening) until surgery (approximately 10 to 20 weeks after screening)</time_frame>
    <description>The number of subjects for whom a biomarker (i.e., molecular profile) was used to determine the course of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histologic Response to Targeted Chemotherapeutic Regimens in Resected Tumors.</measure>
    <time_frame>At time of surgery (approximately 10 to 20 weeks after screening)</time_frame>
    <description>The number of tumors showing a histologic response. Histological response will be measured using the Ryan Score method as defined by the American Joint Committee on Cancer, 7th edition (see Edge, 2010). Grading categories are defined as: Grade 0 (complete response); Grade 1 (near complete response); Grade 2 (partial response); and Grade 3 (poor or no response).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">229</enrollment>
  <condition>Pancreatic Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Milestones related to therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.&#xD;
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 5: After surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 6: Gemcitabine after surgery: 8 weeks standard Gemcitabine (chemotherapy); restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 7: After surgery: chemoradiotherapy (cXRT); restaging. Milestone 8: Gemcitabine after surgery: 8 weeks Gemcitabine (chemotherapy); restaging; 8 weeks Gemcitabine (chemotherapy); restaging.&#xD;
Milestone 9: No additional therapy after surgery. Milestone 10: After surgery no additional treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Milestone 1: Targeted chemotherapy prior to surgery</intervention_name>
    <description>The molecular profile from the biopsy before surgery will point to a particular chemotherapy treatment.</description>
    <arm_group_label>Milestones related to therapy</arm_group_label>
    <other_name>FOLFIRINOX</other_name>
    <other_name>FOLFIRI</other_name>
    <other_name>Gemcitabine with irinotecan</other_name>
    <other_name>Gemcitabine / oxaliplatin</other_name>
    <other_name>Gemcitabine / cisplatinum</other_name>
    <other_name>Gemcitabine / capecitabine</other_name>
    <other_name>Gemcitabine / nab-paclitaxel</other_name>
    <other_name>Capecitabine / nab-paclitaxel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Milestone 2: Chemoradiotherapy (cXRT)</intervention_name>
    <description>A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or intensity-modulated radiation therapy (IMRT) techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).</description>
    <arm_group_label>Milestones related to therapy</arm_group_label>
    <other_name>Gemcitabine</other_name>
    <other_name>Capecitabine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Milestone 3: Targeted chemotherapy prior to surgery</intervention_name>
    <description>The molecular profile from the biopsy before surgery will point to a particular chemotherapy treatment.</description>
    <arm_group_label>Milestones related to therapy</arm_group_label>
    <other_name>FOLFIRINOX</other_name>
    <other_name>FOLFIRI</other_name>
    <other_name>Gemcitabine with irinotecan</other_name>
    <other_name>Gemcitabine / oxaliplatin</other_name>
    <other_name>Gemcitabine / cisplatinum</other_name>
    <other_name>Gemcitabine / capecitabine</other_name>
    <other_name>Gemcitabine / nab-paclitaxel</other_name>
    <other_name>Capecitabine / nab-paclitaxel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Milestone 3: Chemoradiotherapy (cXRT)</intervention_name>
    <description>A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).</description>
    <arm_group_label>Milestones related to therapy</arm_group_label>
    <other_name>Gemcitabine</other_name>
    <other_name>Capecitabine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery</intervention_name>
    <description>A biopsy of the borderline tumor does not provide a molecular profile that can be used to target treatment. The treatment will be standard FOLFIRINOX chemotherapy regimen.</description>
    <arm_group_label>Milestones related to therapy</arm_group_label>
    <other_name>FOLFIRINOX</other_name>
    <other_name>oxaliplatin</other_name>
    <other_name>irinotecan</other_name>
    <other_name>leucovorin</other_name>
    <other_name>5 fluorouracil</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Milestone 4: Chemoradiotherapy (cXRT)</intervention_name>
    <description>A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).</description>
    <arm_group_label>Milestones related to therapy</arm_group_label>
    <other_name>Gemcitabine</other_name>
    <other_name>Capecitabine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Milestone 5: Targeted chemotherapy after surgery</intervention_name>
    <description>The molecular profile from the surgical specimen will point to a particular chemotherapy treatment.</description>
    <arm_group_label>Milestones related to therapy</arm_group_label>
    <other_name>FOLFIRINOX</other_name>
    <other_name>FOLFIRI</other_name>
    <other_name>Gemcitabine with irinotecan</other_name>
    <other_name>Gemcitabine / oxaliplatin</other_name>
    <other_name>Gemcitabine / cisplatinum</other_name>
    <other_name>Gemcitabine / capecitabine</other_name>
    <other_name>Gemcitabine / nab-paclitaxel</other_name>
    <other_name>Capecitabine / nab-paclitaxel</other_name>
    <other_name>Gemcitabine</other_name>
    <other_name>Capecitabine</other_name>
    <other_name>5-Fluorouracil</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Milestone 5: Chemoradiotherapy (cXRT)</intervention_name>
    <description>A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).</description>
    <arm_group_label>Milestones related to therapy</arm_group_label>
    <other_name>Gemcitabine</other_name>
    <other_name>Capecitabine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Milestone 6: Gemcitabine after surgery</intervention_name>
    <description>Chemotherapy treatment with Gemcitabine.</description>
    <arm_group_label>Milestones related to therapy</arm_group_label>
    <other_name>Chemotherapy treatment with Gemcitabine.</other_name>
    <other_name>Gemzar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Milestone 6: Chemoradiotherapy (cXRT)</intervention_name>
    <description>A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).</description>
    <arm_group_label>Milestones related to therapy</arm_group_label>
    <other_name>Gemcitabine</other_name>
    <other_name>Capecitabine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Milestone 7: Chemoradiotherapy (cXRT)</intervention_name>
    <description>A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).</description>
    <arm_group_label>Milestones related to therapy</arm_group_label>
    <other_name>Gemcitabine</other_name>
    <other_name>Capecitabine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Milestone 8: Targeted chemotherapy after surgery</intervention_name>
    <description>The molecular profile from the surgical specimen will point to a particular chemotherapy treatment.</description>
    <arm_group_label>Milestones related to therapy</arm_group_label>
    <other_name>FOLFIRINOX</other_name>
    <other_name>FOLFIRI</other_name>
    <other_name>Gemcitabine with irinotecan</other_name>
    <other_name>Gemcitabine / oxaliplatin</other_name>
    <other_name>Gemcitabine / cisplatinum</other_name>
    <other_name>Gemcitabine / capecitabine</other_name>
    <other_name>Gemcitabine / nab-paclitaxel</other_name>
    <other_name>Capecitabine / nab-paclitaxel</other_name>
    <other_name>Gemcitabine</other_name>
    <other_name>Capecitabine</other_name>
    <other_name>5 fluorouracil</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Milestone 9: Gemcitabine after surgery</intervention_name>
    <description>Chemotherapy treatment with Gemcitabine.</description>
    <arm_group_label>Milestones related to therapy</arm_group_label>
    <other_name>Gemzar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Milestone 10: No additional therapy after surgery</intervention_name>
    <description>The molecular profile of the tumor that was removed during surgery points to a lack of treatment affect for available therapies. No additional therapy is recommended.</description>
    <arm_group_label>Milestones related to therapy</arm_group_label>
    <other_name>Restaged after surgery. No additional therapy.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Able to understand and provide written informed consent&#xD;
&#xD;
          -  Diagnosis of adenocarcinoma of the pancreas or high suspicion of adenocarcinoma of the&#xD;
             pancreas based on CT and MRI findings as detailed below by &quot;Definition of....&quot;&#xD;
&#xD;
        Treatment Eligibility Criteria:&#xD;
&#xD;
          -  Have an Eastern Cooperative Oncology Group performance status less than or equal to 2&#xD;
&#xD;
          -  Have biopsy-proven resectable or borderline resectable adenocarcinoma of the pancreas&#xD;
&#xD;
          -  Have adequate organ and bone marrow function as defined by:&#xD;
&#xD;
               -  total leukocytes greater than or equal to 3 x1000/μL&#xD;
&#xD;
               -  absolute neutrophil count (ANC) &gt; or equal to 1.5x 1000/μL&#xD;
&#xD;
               -  hemoglobin &gt; or equal to 9 g/dL&#xD;
&#xD;
               -  platelets &gt; or equal to 100 x 1000/μL&#xD;
&#xD;
               -  creatinine clearance &gt;60 mL/min or creatinine &lt; or equal to 1.5 mg/dL&#xD;
&#xD;
               -  bilirubin &lt; or equal to 2 mg/dL or &gt;2 and declining as described in the protocol&#xD;
&#xD;
               -  aspartate transaminases (AST/SGOT) &lt; or equal to3 x upper limit of normal (ULN)&#xD;
&#xD;
               -  alanine transaminases (ALT/SGPT) &lt; or equal to 3 x ULN&#xD;
&#xD;
          -  Female patients must be post menopausal for &gt; 1 year, surgically sterile, or have a&#xD;
             negative pregnancy test and used at least one form of contraception for 4 weeks prior&#xD;
             to Day 1 of the study, during study treatment and during the first 4 months after&#xD;
             study treatment is discontinued. Male patients must be surgically sterile or use&#xD;
             barrier contraception during the study and for 4 months after the last dose of any&#xD;
             study drug.&#xD;
&#xD;
        Definition of Resectable Pancreatic Cancer includes:&#xD;
&#xD;
          -  No evidence of extra-pancreatic disease&#xD;
&#xD;
          -  No evidence of tumor-arterial abutment (celiac, superior mesenteric artery or hepatic&#xD;
             artery)&#xD;
&#xD;
          -  If tumor induced narrowing of the superior mesenteric vein, portal vein or superior&#xD;
             mesenteric-portal vein confluence is present it must be &lt;50% of the diameter of the&#xD;
             vessel&#xD;
&#xD;
          -  Ca19-9 &lt;5000, when bilirubin is &lt;2 (or &gt;2 and declining as described in the protocol)&#xD;
&#xD;
        Definition of Borderline Resectable Pancreatic Cancer to include at least one of the&#xD;
        following:&#xD;
&#xD;
          -  Tumor abutment &lt; or equal to 180 degrees of the superior mesenteric artery or celiac&#xD;
             axis&#xD;
&#xD;
          -  Tumor abutment or encasement (&gt;180 degrees) of a short segment of the hepatic artery&#xD;
&#xD;
          -  Tumor induced narrowing of superior mesenteric vein, portal vein or superior&#xD;
             mesenteric-portal vein of &gt;50% of the diameter of the vessel.&#xD;
&#xD;
          -  Short segment occlusion of the superior mesenteric vein, portal vein or superior&#xD;
             mesenteric-portal vein confluence with a suitable portal vein above and superior&#xD;
             mesenteric vein below, for reconstruction&#xD;
&#xD;
          -  CT or MRI findings suspicious for, but not diagnostic of, metastatic disease (based on&#xD;
             multidisciplinary assessment at the Medical College of Wisconsin weekly pancreatic&#xD;
             cancer conference)&#xD;
&#xD;
          -  Biopsy proven N1 disease (regional lymph nodes involved) from pre-referral biopsy or&#xD;
             endoscopic ultrasound-guided fine needle aspirate&#xD;
&#xD;
          -  Resectable tumor and cancer antigen 19-9 (CA19-9) &gt;5000&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Any patient with one or more of the following will be excluded:&#xD;
&#xD;
          -  Have received chemotherapy or chemoradiation within 5 years prior of study enrollment&#xD;
&#xD;
          -  Have any previous history of another malignancy (other than cured basal or squamous&#xD;
             cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of&#xD;
             study enrollment&#xD;
&#xD;
          -  Uncontrolled comorbidities including, but not limited to, ongoing or active serious&#xD;
             infection, symptomatic congestive heart failure, unstable angina, unstable cardiac&#xD;
             arrhythmias, psychiatric illness, excessive obesity, or situations that would limit&#xD;
             compliance with the study requirements or the ability to willingly give written&#xD;
             informed consent&#xD;
&#xD;
          -  Known human immunodeficiency virus, hepatitis B virus, or hepatitis C virus infection&#xD;
&#xD;
          -  Pregnant or breast-feeding patients or any patient with child-bearing potential not&#xD;
             using contraception 4 weeks prior to, during and 4 months after study treatment is&#xD;
             discontinued&#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>Douglas B. Evans, M.D., FACS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical College of Wisconsin</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kathleen Christians, M.D., FACS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical College of Wisconsin</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Susan Tsai, M.D., M.H.S.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical College of Wisconsin</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paul Ritch, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical College of Wisconsin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Cincinnati Cancer Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Froedtert and The Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Edge SB, Compton CC. The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual and the future of TNM. Ann Surg Oncol. 2010 Jun;17(6):1471-4. doi: 10.1245/s10434-010-0985-4.</citation>
    <PMID>20180029</PMID>
  </reference>
  <results_reference>
    <citation>Tsai S, Christians KK, George B, Ritch PS, Dua K, Khan A, Mackinnon AC, Tolat P, Ahmad SA, Hall WA, Erickson BA, Evans DB. A Phase II Clinical Trial of Molecular Profiled Neoadjuvant Therapy for Localized Pancreatic Ductal Adenocarcinoma. Ann Surg. 2018 Oct;268(4):610-619. doi: 10.1097/SLA.0000000000002957.</citation>
    <PMID>30080723</PMID>
  </results_reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 28, 2011</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <results_first_submitted>May 22, 2023</results_first_submitted>
  <results_first_submitted_qc>July 20, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 14, 2023</results_first_posted>
  <last_update_submitted>July 20, 2023</last_update_submitted>
  <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical College of Wisconsin</investigator_affiliation>
    <investigator_full_name>Susan Tsai</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>pancreas</keyword>
  <keyword>adenocarcinoma</keyword>
  <keyword>molecular profile</keyword>
  <keyword>molecular profiling</keyword>
  <keyword>pancreatic cancer</keyword>
  <keyword>pancreas cancer</keyword>
  <keyword>cancer</keyword>
  <keyword>molecular target</keyword>
  <keyword>pancreas head</keyword>
  <keyword>pancreas neck</keyword>
  <keyword>pancreas uncinate</keyword>
  <keyword>pancreas body</keyword>
  <keyword>pancreas tail</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leucovorin</mesh_term>
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Fluorouracil</mesh_term>
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Irinotecan</mesh_term>
    <mesh_term>Cisplatin</mesh_term>
    <mesh_term>Folfirinox</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>June 28, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT01726582/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT01726582/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Milestones Related to Standard Therapy</title>
          <description>The milestones described below represent the treatment progression patients follow for treatment of this disease. The milestone represents changes in therapy based on medical condition and are not intended to represent discrete events in the investigation. Study are not parsed for analysis among the treatment milestones.&#xD;
Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.&#xD;
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 5: After surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 6: Gemcitabine after surgery: 8 weeks standard Gemcitabine (chemotherapy); restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 7: After surgery: chemoradiotherapy (cXRT); restaging. Milestone 8: Gemcitabine after surgery: 8 weeks Gemcitabine (chemotherapy); restaging; 8 weeks Gemcitabine (chemotherapy); restaging.&#xD;
Milestone 9: No additional therapy after surgery. Milestone 10: After surgery no additional treatment.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="229"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="130"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="184"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="99"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="85"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Milestones Related to Therapy</title>
          <description>Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.&#xD;
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 5: After surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 6: Gemcitabine after surgery: 8 weeks standard Gemcitabine (chemotherapy); restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 7: After surgery: chemoradiotherapy (cXRT); restaging. Milestone 8: Gemcitabine after surgery: 8 weeks Gemcitabine (chemotherapy); restaging; 8 weeks Gemcitabine (chemotherapy); restaging.&#xD;
Milestone 9: No additional therapy after surgery. Milestone 10: After surgery no additional treatment.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="130"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.1" spread="8.9"/>
                  </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="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="124"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="122"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects Completing Therapy Including Surgical Resection.</title>
        <description>This outcome measure is the number of subjects completing therapy up to and including surgical resection. In this context, surgical excision of residual tumor is an option in the progression of usual care. Surgery was contraindicated for some participants. This measure is the number of subject who were eligible for and completed the surgical procedure.</description>
        <time_frame>At time of surgery (approximately 10 to 20 weeks after screening)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Milestones Related to Usual Therapy</title>
            <description>Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.&#xD;
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 5: After surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 6: Gemcitabine after surgery: 8 weeks standard Gemcitabine (chemotherapy); restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 7: After surgery: chemoradiotherapy (cXRT); restaging. Milestone 8: Gemcitabine after surgery: 8 weeks Gemcitabine (chemotherapy); restaging; 8 weeks Gemcitabine (chemotherapy); restaging.&#xD;
Milestone 9: No additional therapy after surgery. Milestone 10: After surgery no additional treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Completing Therapy Including Surgical Resection.</title>
          <description>This outcome measure is the number of subjects completing therapy up to and including surgical resection. In this context, surgical excision of residual tumor is an option in the progression of usual care. Surgery was contraindicated for some participants. This measure is the number of subject who were eligible for and completed the surgical procedure.</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="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival in Months</title>
        <description>This measure is the median time of survival (in months) at five years from the initiation of therapy. Results will be presented for two cohorts: subjects completing neoadjuvant therapy and surgical resection; and subjects completing neoadjuvant therapy but without surgical resection.</description>
        <time_frame>5 years</time_frame>
        <population>Results will be presented for two cohorts: subjects completing neoadjuvant therapy and surgical resection; and subjects completing neoadjuvant therapy but without surgical resection.</population>
        <group_list>
          <group group_id="O1">
            <title>Milestones Related to Therapy (Resected)</title>
            <description>This population includes the participants who were eligible for and completed surgical resection of residual tumor. Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.&#xD;
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 5: After surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 6: Gemcitabine after surgery: 8 weeks standard Gemcitabine (chemotherapy); restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 7: After surgery: chemoradiotherapy (cXRT); restaging. Milestone 8: Gemcitabine after surgery: 8 weeks Gemcitabine (chemotherapy); restaging; 8 weeks Gemcitabine (chemotherapy); restaging.&#xD;
Milestone 9: No additional therapy after surgery. Milestone 10: After surgery no additional treatment.</description>
          </group>
          <group group_id="O2">
            <title>Milestones Related to Therapy (Non-Resected)</title>
            <description>This population includes participants for whom surgical resection was contraindicated and did not occur.&#xD;
Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.&#xD;
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival in Months</title>
          <description>This measure is the median time of survival (in months) at five years from the initiation of therapy. Results will be presented for two cohorts: subjects completing neoadjuvant therapy and surgical resection; and subjects completing neoadjuvant therapy but without surgical resection.</description>
          <population>Results will be presented for two cohorts: subjects completing neoadjuvant therapy and surgical resection; and subjects completing neoadjuvant therapy but without surgical resection.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45" lower_limit="24" upper_limit="60"/>
                    <measurement group_id="O2" value="11" lower_limit="8" upper_limit="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-free Survival</title>
        <description>This measure is the number of subjects not experiencing tumor progression at five years from initiating therapy.</description>
        <time_frame>5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Milestones Related to Usual Therapy</title>
            <description>Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.&#xD;
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 5: After surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 6: Gemcitabine after surgery: 8 weeks standard Gemcitabine (chemotherapy); restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 7: After surgery: chemoradiotherapy (cXRT); restaging. Milestone 8: Gemcitabine after surgery: 8 weeks Gemcitabine (chemotherapy); restaging; 8 weeks Gemcitabine (chemotherapy); restaging.&#xD;
Milestone 9: No additional therapy after surgery. Milestone 10: After surgery no additional treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival</title>
          <description>This measure is the number of subjects not experiencing tumor progression at five years from initiating therapy.</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="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Use of Biomarkers to Determine Course of Treatment</title>
        <description>The number of subjects for whom a biomarker (i.e., molecular profile) was used to determine the course of treatment.</description>
        <time_frame>Initiation of therapy (approximately 4 to 12 weeks after screening) until surgery (approximately 10 to 20 weeks after screening)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Milestones Related to Usual Therapy</title>
            <description>Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.&#xD;
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 5: After surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 6: Gemcitabine after surgery: 8 weeks standard Gemcitabine (chemotherapy); restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 7: After surgery: chemoradiotherapy (cXRT); restaging. Milestone 8: Gemcitabine after surgery: 8 weeks Gemcitabine (chemotherapy); restaging; 8 weeks Gemcitabine (chemotherapy); restaging.&#xD;
Milestone 9: No additional therapy after surgery. Milestone 10: After surgery no additional treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Use of Biomarkers to Determine Course of Treatment</title>
          <description>The number of subjects for whom a biomarker (i.e., molecular profile) was used to determine the course of treatment.</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="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Histologic Response to Targeted Chemotherapeutic Regimens in Resected Tumors.</title>
        <description>The number of tumors showing a histologic response. Histological response will be measured using the Ryan Score method as defined by the American Joint Committee on Cancer, 7th edition (see Edge, 2010). Grading categories are defined as: Grade 0 (complete response); Grade 1 (near complete response); Grade 2 (partial response); and Grade 3 (poor or no response).</description>
        <time_frame>At time of surgery (approximately 10 to 20 weeks after screening)</time_frame>
        <population>Pathology results were not reported for two subject.</population>
        <group_list>
          <group group_id="O1">
            <title>Milestones Related to Usual Therapy</title>
            <description>Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.&#xD;
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 5: After surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 6: Gemcitabine after surgery: 8 weeks standard Gemcitabine (chemotherapy); restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 7: After surgery: chemoradiotherapy (cXRT); restaging. Milestone 8: Gemcitabine after surgery: 8 weeks Gemcitabine (chemotherapy); restaging; 8 weeks Gemcitabine (chemotherapy); restaging.&#xD;
Milestone 9: No additional therapy after surgery. Milestone 10: After surgery no additional treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Histologic Response to Targeted Chemotherapeutic Regimens in Resected Tumors.</title>
          <description>The number of tumors showing a histologic response. Histological response will be measured using the Ryan Score method as defined by the American Joint Committee on Cancer, 7th edition (see Edge, 2010). Grading categories are defined as: Grade 0 (complete response); Grade 1 (near complete response); Grade 2 (partial response); and Grade 3 (poor or no response).</description>
          <population>Pathology results were not reported for two subject.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Complete Response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Near Complete Response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Partial Response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Poor or No Response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Results Not Available</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>5 years</time_frame>
      <desc>The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.</desc>
      <group_list>
        <group group_id="E1">
          <title>Milestones Related to Therapy</title>
          <description>Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.&#xD;
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 5: After surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 6: Gemcitabine after surgery: 8 weeks standard Gemcitabine (chemotherapy); restaging; chemoradiotherapy (cXRT); restaging.&#xD;
Milestone 7: After surgery: chemoradiotherapy (cXRT); restaging. Milestone 8: Gemcitabine after surgery: 8 weeks Gemcitabine (chemotherapy); restaging; 8 weeks Gemcitabine (chemotherapy); restaging.&#xD;
Milestone 9: No additional therapy after surgery. Milestone 10: After surgery no additional treatment.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE v4.03</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="85" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Febrile neutorpenia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Colonic hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Duodenal obstruction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Gastric hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Gastroparesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Jejunal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Mucositis oral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Edema limbs</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Flu-like symptoms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Gallbladder obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Biliary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Catheter related infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Suicidal attempt</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="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>Susan Tsai, MD</name_or_title>
      <organization>Froedtert and the Medical College of Wisconsin</organization>
      <phone>414-955-1412</phone>
      <email>stsai@mcw.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/NCT01726582
org study id: MCW 15565
secondary id: Advancing a Healthier WI
secondary id: FP 7718
nct id: NCT01726582
lead sponsor: 
collaborator: 
has dmc: Yes
In this clinical trial, if the doctor knows or suspects that a growth in the pancreas is
      cancer (adenocarcinoma), then a sample of the growth is tested (the test is called molecular
      profiling). The results of the test are used by the doctor to recommend therapy (chemotherapy
      and radiation therapy) that the patient will receive before having surgery to remove the
      adenocarcinoma. When the patient goes to surgery, the adenocarcinoma that is removed is
      tested again. The results of that test are used to guide the choice of therapy after surgery.

      The chemotherapy drugs and the radiation therapy used in this clinical trial are already
      approved for treatment of pancreas cancer. This trial is intended to establish which
      treatment is best for a specific patient, based on test results from that patient's actual
      adenocarcinoma. In the past, the decision as to which treatment the patient will receive was
      not based on testing of the actual adenocarcinoma.

      See treatment pathways at http://www.mcw.edu/surgery/patientinfo/Pancreatic-Cancer-Trial.htm.

      Hypothesis: Resectability rate, overall survival rate and progression-free survival in
      subjects with adenocarcinoma of the pancreas will be superior for who receive targeted
      "personalized" therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Subjects Completing Therapy Including Surgical Resection.
time frame: At time of surgery (approximately 10 to 20 weeks after screening)
description: This outcome measure is the number of subjects completing therapy up to and including surgical resection. In this context, surgical excision of residual tumor is an option in the progression of usual care. Surgery was contraindicated for some participants. This measure is the number of subject who were eligible for and completed the surgical procedure.
measure: Overall Survival in Months
time frame: 5 years
description: This measure is the median time of survival (in months) at five years from the initiation of therapy. Results will be presented for two cohorts: subjects completing neoadjuvant therapy and surgical resection; and subjects completing neoadjuvant therapy but without surgical resection.
measure: Progression-free Survival
time frame: 5 years
description: This measure is the number of subjects not experiencing tumor progression at five years from initiating therapy.
measure: Use of Biomarkers to Determine Course of Treatment
time frame: Initiation of therapy (approximately 4 to 12 weeks after screening) until surgery (approximately 10 to 20 weeks after screening)
description: The number of subjects for whom a biomarker (i.e., molecular profile) was used to determine the course of treatment.
measure: Histologic Response to Targeted Chemotherapeutic Regimens in Resected Tumors.
time frame: At time of surgery (approximately 10 to 20 weeks after screening)
description: The number of tumors showing a histologic response. Histological response will be measured using the Ryan Score method as defined by the American Joint Committee on Cancer, 7th edition (see Edge, 2010). Grading categories are defined as: Grade 0 (complete response); Grade 1 (near complete response); Grade 2 (partial response); and Grade 3 (poor or no response).
arm group label: Milestones related to therapy
arm group type: Experimental
description: Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.
Milestone 5: After surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 6: Gemcitabine after surgery: 8 weeks standard Gemcitabine (chemotherapy); restaging; chemoradiotherapy (cXRT); restaging.
Milestone 7: After surgery: chemoradiotherapy (cXRT); restaging. Milestone 8: Gemcitabine after surgery: 8 weeks Gemcitabine (chemotherapy); restaging; 8 weeks Gemcitabine (chemotherapy); restaging.
Milestone 9: No additional therapy after surgery. Milestone 10: After surgery no additional treatment.
intervention type: Drug
intervention name: Milestone 1: Targeted chemotherapy prior to surgery
description: The molecular profile from the biopsy before surgery will point to a particular chemotherapy treatment.
arm group label: Milestones related to therapy
other name: FOLFIRINOX
other name: FOLFIRI
other name: Gemcitabine with irinotecan
other name: Gemcitabine / oxaliplatin
other name: Gemcitabine / cisplatinum
other name: Gemcitabine / capecitabine
other name: Gemcitabine / nab-paclitaxel
other name: Capecitabine / nab-paclitaxel
intervention type: Radiation
intervention name: Milestone 2: Chemoradiotherapy (cXRT)
description: A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or intensity-modulated radiation therapy (IMRT) techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).
arm group label: Milestones related to therapy
other name: Gemcitabine
other name: Capecitabine
intervention type: Drug
intervention name: Milestone 3: Targeted chemotherapy prior to surgery
description: The molecular profile from the biopsy before surgery will point to a particular chemotherapy treatment.
arm group label: Milestones related to therapy
other name: FOLFIRINOX
other name: FOLFIRI
other name: Gemcitabine with irinotecan
other name: Gemcitabine / oxaliplatin
other name: Gemcitabine / cisplatinum
other name: Gemcitabine / capecitabine
other name: Gemcitabine / nab-paclitaxel
other name: Capecitabine / nab-paclitaxel
intervention type: Radiation
intervention name: Milestone 3: Chemoradiotherapy (cXRT)
description: A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).
arm group label: Milestones related to therapy
other name: Gemcitabine
other name: Capecitabine
intervention type: Drug
intervention name: Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery
description: A biopsy of the borderline tumor does not provide a molecular profile that can be used to target treatment. The treatment will be standard FOLFIRINOX chemotherapy regimen.
arm group label: Milestones related to therapy
other name: FOLFIRINOX
other name: oxaliplatin
other name: irinotecan
other name: leucovorin
other name: 5 fluorouracil
intervention type: Radiation
intervention name: Milestone 4: Chemoradiotherapy (cXRT)
description: A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).
arm group label: Milestones related to therapy
other name: Gemcitabine
other name: Capecitabine
intervention type: Drug
intervention name: Milestone 5: Targeted chemotherapy after surgery
description: The molecular profile from the surgical specimen will point to a particular chemotherapy treatment.
arm group label: Milestones related to therapy
other name: FOLFIRINOX
other name: FOLFIRI
other name: Gemcitabine with irinotecan
other name: Gemcitabine / oxaliplatin
other name: Gemcitabine / cisplatinum
other name: Gemcitabine / capecitabine
other name: Gemcitabine / nab-paclitaxel
other name: Capecitabine / nab-paclitaxel
other name: Gemcitabine
other name: Capecitabine
other name: 5-Fluorouracil
intervention type: Radiation
intervention name: Milestone 5: Chemoradiotherapy (cXRT)
description: A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).
arm group label: Milestones related to therapy
other name: Gemcitabine
other name: Capecitabine
intervention type: Drug
intervention name: Milestone 6: Gemcitabine after surgery
description: Chemotherapy treatment with Gemcitabine.
arm group label: Milestones related to therapy
other name: Chemotherapy treatment with Gemcitabine.
other name: Gemzar
intervention type: Radiation
intervention name: Milestone 6: Chemoradiotherapy (cXRT)
description: A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).
arm group label: Milestones related to therapy
other name: Gemcitabine
other name: Capecitabine
intervention type: Radiation
intervention name: Milestone 7: Chemoradiotherapy (cXRT)
description: A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).
arm group label: Milestones related to therapy
other name: Gemcitabine
other name: Capecitabine
intervention type: Drug
intervention name: Milestone 8: Targeted chemotherapy after surgery
description: The molecular profile from the surgical specimen will point to a particular chemotherapy treatment.
arm group label: Milestones related to therapy
other name: FOLFIRINOX
other name: FOLFIRI
other name: Gemcitabine with irinotecan
other name: Gemcitabine / oxaliplatin
other name: Gemcitabine / cisplatinum
other name: Gemcitabine / capecitabine
other name: Gemcitabine / nab-paclitaxel
other name: Capecitabine / nab-paclitaxel
other name: Gemcitabine
other name: Capecitabine
other name: 5 fluorouracil
intervention type: Drug
intervention name: Milestone 9: Gemcitabine after surgery
description: Chemotherapy treatment with Gemcitabine.
arm group label: Milestones related to therapy
other name: Gemzar
intervention type: Other
intervention name: Milestone 10: No additional therapy after surgery
description: The molecular profile of the tumor that was removed during surgery points to a lack of treatment affect for available therapies. No additional therapy is recommended.
arm group label: Milestones related to therapy
other name: Restaged after surgery. No additional therapy.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Douglas B. Evans, M.D., FACS
role: Principal Investigator
affiliation: Medical College of Wisconsin
last name: Kathleen Christians, M.D., FACS
role: Principal Investigator
affiliation: Medical College of Wisconsin
last name: Susan Tsai, M.D., M.H.S.
role: Principal Investigator
affiliation: Medical College of Wisconsin
last name: Paul Ritch, M.D.
role: Principal Investigator
affiliation: Medical College of Wisconsin
facility: 
facility: 
country: United States
citation: Edge SB, Compton CC. The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual and the future of TNM. Ann Surg Oncol. 2010 Jun;17(6):1471-4. doi: 10.1245/s10434-010-0985-4.
PMID: 20180029
citation: Tsai S, Christians KK, George B, Ritch PS, Dua K, Khan A, Mackinnon AC, Tolat P, Ahmad SA, Hall WA, Erickson BA, Evans DB. A Phase II Clinical Trial of Molecular Profiled Neoadjuvant Therapy for Localized Pancreatic Ductal Adenocarcinoma. Ann Surg. 2018 Oct;268(4):610-619. doi: 10.1097/SLA.0000000000002957.
PMID: 30080723
responsible party type: Principal Investigator
investigator affiliation: Medical College of Wisconsin
investigator full name: Susan Tsai
investigator title: Professor
mesh term: Adenocarcinoma
mesh term: Leucovorin
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel
mesh term: Gemcitabine
mesh term: Fluorouracil
mesh term: Capecitabine
mesh term: Oxaliplatin
mesh term: Irinotecan
mesh term: Cisplatin
mesh term: Folfirinox
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 