<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/NCT04423731</url>
  </required_header>
  <id_info>
    <org_study_id>2017/1382/REK nord</org_study_id>
    <nct_id>NCT04423731</nct_id>
  </id_info>
  <brief_title>Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer</brief_title>
  <official_title>Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer - A Norwegian Population Based Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital of North Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Helse Stavanger HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Norwegian prospective observational study that evaluates the resectability rate in&#xD;
      patients with borderline resectable and locally advanced pancreatic cancer who received&#xD;
      neoadjuvant chemotherapy in a population based cohort. Eligible patients are treated with&#xD;
      neoadjuvant chemotherapy possibly followed by surgical exploration and resection. All&#xD;
      Norwegian centres performing pancreatic surgery have agreed to collaborate in this trial. The&#xD;
      assignment of the medical intervention is not at the discretion of the investigator, but&#xD;
      follow the national Norwegian guidelines regarding diagnostic work up, oncological and&#xD;
      surgical treatment and follow up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of resectability in both groups (borderline and locally advanced pancreatic cancer)</measure>
    <time_frame>5 years</time_frame>
    <description>Patients who undergo surgical resection will be documented</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival from time of inclusion (intention to treat)</measure>
    <time_frame>Overall survival rate at 5 years using Kaplan-Meier survival analysis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>1 year after inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival following resection</measure>
    <time_frame>Overall survival rate at 5 years using Kaplan-Meier survival analysis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival after 1, 2, 3 and 5 years</measure>
    <time_frame>1, 2, 3 and 5 years after inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1-year progression-free survival rate</measure>
    <time_frame>1-year after surgical resection</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>Disease-free survival at 5 years using Kaplan-Meier survival analysis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological response</measure>
    <time_frame>2-6 months after initiation of chemotherapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histopathological response</measure>
    <time_frame>14-30 days post surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>R0 resection rate</measure>
    <time_frame>14-30 days post surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rates after surgery classification systems)</measure>
    <time_frame>30 and 90 days post surgery</time_frame>
    <description>Dindo-Clavien and ISPGS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Completion rates of all parts of multimodal treatment</measure>
    <time_frame>Up to 1 year after inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QoL (EORTC QLQ-30)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance status - Eastern Cooperative Oncology Group (ECOG)</measure>
    <time_frame>5 years</time_frame>
    <description>0 - Asymptomatic (Fully active, able to carry on all predisease activities without restriction)&#xD;
- Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work)&#xD;
- Symptomatic, &lt;50% in bed during the day (Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours)&#xD;
- Symptomatic, &gt;50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours)&#xD;
- Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair)</description>
  </secondary_outcome>
  <enrollment type="Actual">251</enrollment>
  <condition>Locally Advanced Pancreatic Adenocarcinoma</condition>
  <condition>Chemotherapy Effect</condition>
  <condition>Borderline Resectable Pancreatic Adenocarcinoma</condition>
  <condition>Pancreatectomy</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Folfirinox</intervention_name>
    <description>Neoadjuvant chemotherapy is given according to different regimens, preferably FOLFIRINOX according to the recommendations in the national Norwegian guidelines. The choice of chemotherapy regimen is decided by the treating oncologist.</description>
    <other_name>Gemcitabine/nab-paclitaxel</other_name>
    <other_name>Gemcitabine</other_name>
    <other_name>5-FU (fluorouracil) and leucovorin</other_name>
    <other_name>FLOX</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Population based cohort from a universal health care system&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  borderline resectable or locally advanced adenocarcinoma of the pancreas (NCCN,&#xD;
             version 2, 2015)&#xD;
&#xD;
          -  Nx, M0 (UICC 8 th version, 2016)&#xD;
&#xD;
          -  cytological or histological confirmation of adenocarcinoma&#xD;
&#xD;
          -  age &gt; 18 year and considered fit for major surgery&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  considered able to receive the study-specific chemotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  co-morbidity precluding pancreatectomy&#xD;
&#xD;
          -  chronic neuropathy ≥ grade 2&#xD;
&#xD;
          -  WHO performance score &gt; 2&#xD;
&#xD;
          -  granulocyte count &lt; 1500 per cubic millimetre&#xD;
&#xD;
          -  platelet count &lt; 100 000 per cubic millimetre&#xD;
&#xD;
          -  serum creatinine &gt; 1.5 UNL (upper limit normal range)&#xD;
&#xD;
          -  albumin &lt; 2,5 g/dl&#xD;
&#xD;
          -  female patients in child-bearing age not using adequate contraception, pregnant or&#xD;
             lactating women&#xD;
&#xD;
          -  mental or physical disorders that could interfere with treatment of with the provision&#xD;
             of informed consent&#xD;
&#xD;
          -  any reason why, in the opinion of the investigator, the patient should not participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Knut J. Labori, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital, Oslo, Norway</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oslo University Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0268</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>September 26, 2022</last_update_submitted>
  <last_update_submitted_qc>September 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Knut Jørgen Labori</investigator_full_name>
    <investigator_title>Consultant surgeon MD, PhD</investigator_title>
  </responsible_party>
  <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>Gemcitabine</mesh_term>
    <mesh_term>Fluorouracil</mesh_term>
    <mesh_term>Folfirinox</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04423731
org study id: 2017/1382/REK nord
nct id: NCT04423731
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a Norwegian prospective observational study that evaluates the resectability rate in
      patients with borderline resectable and locally advanced pancreatic cancer who received
      neoadjuvant chemotherapy in a population based cohort. Eligible patients are treated with
      neoadjuvant chemotherapy possibly followed by surgical exploration and resection. All
      Norwegian centres performing pancreatic surgery have agreed to collaborate in this trial. The
      assignment of the medical intervention is not at the discretion of the investigator, but
      follow the national Norwegian guidelines regarding diagnostic work up, oncological and
      surgical treatment and follow up.
observational model: Cohort
time perspective: Prospective
measure: Rate of resectability in both groups (borderline and locally advanced pancreatic cancer)
time frame: 5 years
description: Patients who undergo surgical resection will be documented
measure: Overall survival from time of inclusion (intention to treat)
time frame: Overall survival rate at 5 years using Kaplan-Meier survival analysis
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: 1 year after inclusion
measure: Overall survival following resection
time frame: Overall survival rate at 5 years using Kaplan-Meier survival analysis
measure: Overall survival after 1, 2, 3 and 5 years
time frame: 1, 2, 3 and 5 years after inclusion
measure: 1-year progression-free survival rate
time frame: 1-year after surgical resection
measure: Disease-free survival
time frame: Disease-free survival at 5 years using Kaplan-Meier survival analysis
measure: Radiological response
time frame: 2-6 months after initiation of chemotherapy
measure: Histopathological response
time frame: 14-30 days post surgery
measure: R0 resection rate
time frame: 14-30 days post surgery
measure: Complication rates after surgery classification systems)
time frame: 30 and 90 days post surgery
description: Dindo-Clavien and ISPGS
measure: Completion rates of all parts of multimodal treatment
time frame: Up to 1 year after inclusion
measure: QoL (EORTC QLQ-30)
time frame: 5 years
measure: Performance status - Eastern Cooperative Oncology Group (ECOG)
time frame: 5 years
description: 0 - Asymptomatic (Fully active, able to carry on all predisease activities without restriction)
- Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work)
- Symptomatic, <50% in bed during the day (Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours)
- Symptomatic, >50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours)
- Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair)
intervention type: Drug
intervention name: Folfirinox
description: Neoadjuvant chemotherapy is given according to different regimens, preferably FOLFIRINOX according to the recommendations in the national Norwegian guidelines. The choice of chemotherapy regimen is decided by the treating oncologist.
other name: Gemcitabine/nab-paclitaxel
other name: Gemcitabine
other name: 5-FU (fluorouracil) and leucovorin
other name: FLOX
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Knut J. Labori, MD, PhD
role: Principal Investigator
affiliation: Oslo University Hospital, Oslo, Norway
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Knut Jørgen Labori
investigator title: Consultant surgeon MD, PhD
mesh term: Adenocarcinoma
mesh term: Leucovorin
mesh term: Paclitaxel
mesh term: Gemcitabine
mesh term: Fluorouracil
mesh term: Folfirinox