<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/NCT03750669</url>
  </required_header>
  <id_info>
    <org_study_id>CISPD-1</org_study_id>
    <nct_id>NCT03750669</nct_id>
  </id_info>
  <brief_title>Sequential Use of AG and mFOLFIRINOX as Neoadjuvant Chemotherapy for Resectable Pancreatic Cancer</brief_title>
  <official_title>Sequential Use of Nab-paclitaxel Plus Gemcitabine and mFOLFIRINOX as Neoadjuvant Chemotherapy for Resectable Pancreatic Cancer: A Randomized Control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prognosis of pancreatic cancer is extremely poor. Current guidelines recommend&#xD;
      Nab-paclitaxel, Gemcitabine and modified Folfirinox as the first-line chemotherapeutic&#xD;
      regimen. Studies have shown that sequential chemotherapeutic regimen can effectively delay&#xD;
      the drug resistance and improve the effect of chemotherapy. Here investigators intend to&#xD;
      assess the effect of sequential treatment with Nab-paclitaxel plus Gemcitabine and modified&#xD;
      Folfirinox as neoadjuvant chemotherapy for resectable pancreatic adenocarcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators chose resectable pancreatic adenocarcinoma patients. The planned treatment was&#xD;
      given to the participants after randomization. Tumor size, recurrence-free survival, overall&#xD;
      survival, drugs related side effects and other endpoints events were recorded and analyzed,&#xD;
      to assess the sequential treatment with Nab-paclitaxel plus Gemcitabine and modified&#xD;
      Folfirinox could or couldn't benefit the prognosis of resectable pancreatic adenocarcinoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 20, 2018</start_date>
  <completion_date type="Anticipated">October 20, 2024</completion_date>
  <primary_completion_date type="Anticipated">October 20, 2023</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>Up to approximately 60 months</time_frame>
    <description>The time of initial response until documented tumor recurrence.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Up to approximately 60 months</time_frame>
    <description>The time of initial response until documented patient death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate</measure>
    <time_frame>Up to approximately 60 months</time_frame>
    <description>The proportion of patients with tumor size reduction of a predefined amount and for a minimum time period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carbohydrate antigen 19-9</measure>
    <time_frame>Up to approximately 60 months</time_frame>
    <description>Serum Carbohydrate antigen 19-9 level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC QLQ - PAN26 score</measure>
    <time_frame>Up to approximately 60 months</time_frame>
    <description>QLQ score assessed by the European Organization for Research and Treatment of Cancer Quality of Life scale for pancreatic cancer (EORTC QLQ - PAN26. For details: PMID 10533475.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious adverse events incidence</measure>
    <time_frame>Up to approximately 60 months</time_frame>
    <description>The proportion of patients with grade 3/4 adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">416</enrollment>
  <condition>Pancreatic Adenocarcinoma Resectable</condition>
  <condition>Neoadjuvant Chemotherapy</condition>
  <arm_group>
    <arm_group_label>Neoadjuvant Chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive the sequential neoadjuvant chemotherapy of AG regimen (nab-paclitaxel plus gemcitabine) and mFOLFIRINOX before resection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients receive surgical treatment without any neoadjuvant treatments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AG regimen</intervention_name>
    <description>Combination of Nab-paclitaxel 125 mg/m^2 and Gemcitabine 1000 mg/m^2</description>
    <arm_group_label>Neoadjuvant Chemotherapy</arm_group_label>
    <other_name>Nab-paclitaxel and Gemcitabine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>mFolfirinox</intervention_name>
    <description>Folic acid 400mg/m^2, 5- fluorouracil 2400mg/m^2 for 46h, irinotecan 135mg/m^2 and oxaliplatin 68mg/m^2</description>
    <arm_group_label>Neoadjuvant Chemotherapy</arm_group_label>
    <other_name>Folic acid, 5- fluorouracil, irinotecan and oxaliplatin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically (histologically or cytologically) confirmed pancreatic ductal&#xD;
             adenocarcinoma (PDAC).&#xD;
&#xD;
          -  No evidence of distant metastasis (such as liver, peritoneum, lung) evaluated by&#xD;
             abdominal contrast-enhanced CT, MRI, and chest CT. PET/CT or other imaging&#xD;
             examinations would be used if necessary.&#xD;
&#xD;
          -  Initial assessment for definitive resectable tumors (resectability judgment is based&#xD;
             on CT enhanced scan or magnetic resonance imaging, NCCN2018 first edition standard).&#xD;
&#xD;
          -  ECOG score 0 or 1.&#xD;
&#xD;
          -  Serum creatinine level is normal, and serum total bilirubin level is less than 1.5 x&#xD;
             ULN.&#xD;
&#xD;
          -  ALT and AST are less than 2 x ULN.&#xD;
&#xD;
          -  If biliary obstruction is observed, biliary decompression should be performed when the&#xD;
             patient is randomly assigned to receive neoadjuvant chemotherapy.&#xD;
&#xD;
          -  Leukocyte count (&gt; 3.5 x 10^6 /mL), neutrophil count (&gt; 1.5 x 10^6 /mL), platelet&#xD;
             count (&gt; 80 x 10^6 /mL), hemoglobin (&gt; 9 g/dL).&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of malignance treatment in the past, excluding basal and cutaneous squamous&#xD;
             cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma&#xD;
&#xD;
          -  Tumor is a local recurrent lesion.&#xD;
&#xD;
          -  Imaging confirmed severe portal hypertension / cavernous transformation.&#xD;
&#xD;
          -  Ascites&#xD;
&#xD;
          -  Gastric outlet obstruction&#xD;
&#xD;
          -  Respiratory failure requires supplementation of oxygen.&#xD;
&#xD;
          -  Immune deficiency syndrome, such as active tuberculosis and HIV infection.&#xD;
&#xD;
          -  Hematological precancerous diseases, such as myelodysplastic syndromes.&#xD;
&#xD;
          -  Major cardiovascular diseases (including myocardial infarction, unstable angina,&#xD;
             congestive heart failure, severe uncontrolled arrhythmia) during the past six months&#xD;
             of enrollment.&#xD;
&#xD;
          -  Evidence of clinical-related or previous interstitial lung disease, such as&#xD;
             noninfectious pneumonia or pulmonary fibrosis, or baseline chest CT scan or chest&#xD;
             X-ray findings&#xD;
&#xD;
          -  Previous or physical findings of central nervous system disease, except for adequately&#xD;
             treated (e.g. primary brain tumors, uncontrolled seizures or strokes with standard&#xD;
             medications)&#xD;
&#xD;
          -  Preexisting neuropathy &gt; 1 (NCI CTCAE).&#xD;
&#xD;
          -  Allograft requires immunosuppressive therapy or other major immunosuppressive&#xD;
             therapies.&#xD;
&#xD;
          -  Severe serious wounds, ulcers or fractures.&#xD;
&#xD;
          -  Confirmed coagulant disease.&#xD;
&#xD;
          -  Clinical evaluation is unacceptable.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tingbo Liang, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of HBP Surgery, SAHZJU</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tingbo Liang, MD PhD</last_name>
    <phone>8613666676128</phone>
    <email>liangtingbo@zju.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Qi Zhang, MD</last_name>
    <phone>8613819137113</phone>
    <email>zhangqi86@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The second affiliated hospital of Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qi Zhang, MD</last_name>
      <phone>8613819137113</phone>
      <email>zhangqi86@zju.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 17, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 20, 2018</last_update_submitted>
  <last_update_submitted_qc>November 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Second Affiliated Hospital, School of Medicine, Zhejiang University</investigator_affiliation>
    <investigator_full_name>Liang Tingbo</investigator_full_name>
    <investigator_title>Director of HBP Surgery, The Second Affiliated Hospital Zhejiang University School of Medicine</investigator_title>
  </responsible_party>
  <keyword>Pancreatic Cancer</keyword>
  <keyword>Pancreatic Adenocarcinoma</keyword>
  <keyword>Gemcitabine</keyword>
  <keyword>Nab-paclitaxel</keyword>
  <keyword>Modified Folfirinox</keyword>
  <keyword>Sequential treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Folic Acid</mesh_term>
    <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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03750669
org study id: CISPD-1
nct id: NCT03750669
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The prognosis of pancreatic cancer is extremely poor. Current guidelines recommend
      Nab-paclitaxel, Gemcitabine and modified Folfirinox as the first-line chemotherapeutic
      regimen. Studies have shown that sequential chemotherapeutic regimen can effectively delay
      the drug resistance and improve the effect of chemotherapy. Here investigators intend to
      assess the effect of sequential treatment with Nab-paclitaxel plus Gemcitabine and modified
      Folfirinox as neoadjuvant chemotherapy for resectable pancreatic adenocarcinoma.
Investigators chose resectable pancreatic adenocarcinoma patients. The planned treatment was
      given to the participants after randomization. Tumor size, recurrence-free survival, overall
      survival, drugs related side effects and other endpoints events were recorded and analyzed,
      to assess the sequential treatment with Nab-paclitaxel plus Gemcitabine and modified
      Folfirinox could or couldn't benefit the prognosis of resectable pancreatic adenocarcinoma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Disease-free survival
time frame: Up to approximately 60 months
description: The time of initial response until documented tumor recurrence.
measure: Overall survival
time frame: Up to approximately 60 months
description: The time of initial response until documented patient death
measure: Objective response rate
time frame: Up to approximately 60 months
description: The proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
measure: Carbohydrate antigen 19-9
time frame: Up to approximately 60 months
description: Serum Carbohydrate antigen 19-9 level
measure: EORTC QLQ - PAN26 score
time frame: Up to approximately 60 months
description: QLQ score assessed by the European Organization for Research and Treatment of Cancer Quality of Life scale for pancreatic cancer (EORTC QLQ - PAN26. For details: PMID 10533475.)
measure: Serious adverse events incidence
time frame: Up to approximately 60 months
description: The proportion of patients with grade 3/4 adverse events
arm group label: Neoadjuvant Chemotherapy
arm group type: Experimental
description: Patients receive the sequential neoadjuvant chemotherapy of AG regimen (nab-paclitaxel plus gemcitabine) and mFOLFIRINOX before resection.
arm group label: control
arm group type: No Intervention
description: Patients receive surgical treatment without any neoadjuvant treatments.
intervention type: Drug
intervention name: AG regimen
description: Combination of Nab-paclitaxel 125 mg/m^2 and Gemcitabine 1000 mg/m^2
arm group label: Neoadjuvant Chemotherapy
other name: Nab-paclitaxel and Gemcitabine
intervention type: Drug
intervention name: mFolfirinox
description: Folic acid 400mg/m^2, 5- fluorouracil 2400mg/m^2 for 46h, irinotecan 135mg/m^2 and oxaliplatin 68mg/m^2
arm group label: Neoadjuvant Chemotherapy
other name: Folic acid, 5- fluorouracil, irinotecan and oxaliplatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Tingbo Liang, MD PhD
role: Principal Investigator
affiliation: Department of HBP Surgery, SAHZJU
last name: Tingbo Liang, MD PhD
phone: 8613666676128
email: liangtingbo@zju.edu.cn
last name: Qi Zhang, MD
phone: 8613819137113
email: zhangqi86@gmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
investigator full name: Liang Tingbo
investigator title: Director of HBP Surgery, The Second Affiliated Hospital Zhejiang University School of Medicine
mesh term: Adenocarcinoma
mesh term: Pancreatic Neoplasms
mesh term: Folic Acid
mesh term: Paclitaxel
mesh term: Gemcitabine
mesh term: Fluorouracil
mesh term: Oxaliplatin
mesh term: Irinotecan
sharing ipd: Undecided