<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/NCT03273374</url>
  </required_header>
  <id_info>
    <org_study_id>3-2017-0171</org_study_id>
    <nct_id>NCT03273374</nct_id>
  </id_info>
  <brief_title>Intraoperative Radiation Therapy for Resectable Pancreatic Cancer</brief_title>
  <official_title>A Prospective, Phase II Study Investigating Efficacy of Intraoperative Radiation Therapy for Resectable Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gangnam Severance Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gangnam Severance Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This phase II study is designed to investigate the efficacy of IORT for patients with&#xD;
      resectable pancreatic adenocarcinoma. The purpose of the study is to show the local&#xD;
      recurrence rate after surgical resection and IORT is superior to that of surgical resection&#xD;
      alone from the historical control. A total of 42 patients will be enrolled, and these&#xD;
      patients will receive IORT of 10 Gy at 5 millimeter depth of the tumor bed, followed by 6&#xD;
      cycles of adjuvant gemcitabine chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Treatment outcomes of pancreatic cancer are poor even after surgical resection, thus patients&#xD;
      may receive adjuvant chemotherapy or chemoradiotherapy. Intraoperative radiotherapy (IORT)&#xD;
      with low energy (50 kV) x-ray allows delivery of a high dose radiation to the tumor bed&#xD;
      during surgery while effectively sparing adjacent critical organs. Another advantage of IORT&#xD;
      is that delivery of IORT does not interfere with the scheduled administration of adjuvant&#xD;
      chemotherapy or chemoradiotherapy. Here we investigate the efficacy of IORT for patients with&#xD;
      resectable pancreatic adenocarcinoma by comparing the local recurrence rate after surical&#xD;
      resection and IORT with that of surgical resection alone from the historical control. A total&#xD;
      of 42 patients will be enrolled in this phase II trial, and these patients will receive IORT&#xD;
      of 10 Gy at 5 millimeter depth of the tumor bed, followed by 6 cycles of adjuvant gemcitabine&#xD;
      chemotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2017</start_date>
  <completion_date type="Actual">August 22, 2022</completion_date>
  <primary_completion_date type="Actual">August 21, 2020</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Intervention: intraoperative radiotherapy</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Local recurrence rate</measure>
    <time_frame>12 months</time_frame>
    <description>Local recurrence rate</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Resectable Pancreatic Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>IORT group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intraoperative radiation therapy of 10 Gy delivered during surgery followed by adjuvant gemcitabine chemotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intraoperative radiation therapy (IORT)</intervention_name>
    <description>IORT with 50 kV x-ray will be delivered during surgery as a single dose of 10 Gy at 5 millimeter depths of the tumor bed, followed by gemcitabine chemotherapy (1000 mg/m2) every 4 weeks for a total of 6 cycles</description>
    <arm_group_label>IORT group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Pathologically confirmed pancreatic adenocarcinoma 2. Age ≥20 years 3. Performance&#xD;
             status ECOG 0-2 4. Patients must have resectable disease. In order to be resectable&#xD;
             the following criteria must be met:&#xD;
&#xD;
          -  Absence of distant metastases&#xD;
&#xD;
          -  Clear fat planes around the celiac axis, hepatic artery, and superior mesenteric&#xD;
             artery&#xD;
&#xD;
          -  Absence of direct involvement of inferior vena cava or aorta&#xD;
&#xD;
          -  Stage I-III disease per AJCC 7th edition 5. Laboratory data obtained ≤14 days prior to&#xD;
             registration on study, with adequate bone marrow and renal function defined as&#xD;
             follows:&#xD;
&#xD;
          -  Hemoglobin &gt;10 g/dL, Absolute Neutrophil Count (ANC) &gt;1,500/mm3, Platelets&#xD;
             &gt;100,000/mm3&#xD;
&#xD;
          -  Serum Cr &lt;1.4 mg/dL, BUN &lt;20 mg/dL 6. Ability to understand and the willingness to&#xD;
             sign a written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Patients who have received external beam radiotherapy in the abdominal area 2.&#xD;
             Defined treatment area which cannot be adequately covered by the radiation field as&#xD;
             defined by the radiation oncology treatment team 3. Patients who have received&#xD;
             neoadjuvant chemotherapy 4. Stage IV disease 5. Patients with distant metastases 6.&#xD;
             Current pregnancy or currently nursing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ik Jae Lee</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gangnam Severance Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gangnam Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>September 3, 2017</study_first_submitted>
  <study_first_submitted_qc>September 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 11, 2023</last_update_submitted>
  <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gangnam Severance Hospital</investigator_affiliation>
    <investigator_full_name>Ik Jae Lee</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT03273374
org study id: 3-2017-0171
nct id: NCT03273374
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This phase II study is designed to investigate the efficacy of IORT for patients with
      resectable pancreatic adenocarcinoma. The purpose of the study is to show the local
      recurrence rate after surgical resection and IORT is superior to that of surgical resection
      alone from the historical control. A total of 42 patients will be enrolled, and these
      patients will receive IORT of 10 Gy at 5 millimeter depth of the tumor bed, followed by 6
      cycles of adjuvant gemcitabine chemotherapy.
Treatment outcomes of pancreatic cancer are poor even after surgical resection, thus patients
      may receive adjuvant chemotherapy or chemoradiotherapy. Intraoperative radiotherapy (IORT)
      with low energy (50 kV) x-ray allows delivery of a high dose radiation to the tumor bed
      during surgery while effectively sparing adjacent critical organs. Another advantage of IORT
      is that delivery of IORT does not interfere with the scheduled administration of adjuvant
      chemotherapy or chemoradiotherapy. Here we investigate the efficacy of IORT for patients with
      resectable pancreatic adenocarcinoma by comparing the local recurrence rate after surical
      resection and IORT with that of surgical resection alone from the historical control. A total
      of 42 patients will be enrolled in this phase II trial, and these patients will receive IORT
      of 10 Gy at 5 millimeter depth of the tumor bed, followed by 6 cycles of adjuvant gemcitabine
      chemotherapy.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Intervention: intraoperative radiotherapy
primary purpose: Treatment
masking: None (Open Label)
measure: Local recurrence rate
time frame: 12 months
description: Local recurrence rate
arm group label: IORT group
arm group type: Experimental
description: Intraoperative radiation therapy of 10 Gy delivered during surgery followed by adjuvant gemcitabine chemotherapy
intervention type: Device
intervention name: Intraoperative radiation therapy (IORT)
description: IORT with 50 kV x-ray will be delivered during surgery as a single dose of 10 Gy at 5 millimeter depths of the tumor bed, followed by gemcitabine chemotherapy (1000 mg/m2) every 4 weeks for a total of 6 cycles
arm group label: IORT group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: No
last name: Ik Jae Lee
role: Principal Investigator
affiliation: Gangnam Severance Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Gangnam Severance Hospital
investigator full name: Ik Jae Lee
investigator title: Principal Investigator