<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/NCT02981641</url>
  </required_header>
  <id_info>
    <org_study_id>2012AA022701</org_study_id>
    <nct_id>NCT02981641</nct_id>
  </id_info>
  <brief_title>IORT Versus CCRT for Pancreatic Cancer</brief_title>
  <acronym>IVCPC</acronym>
  <official_title>Intraoperative Radiotherapy (IORT) Versus Concurrent Chemoradiotherapy (CCRT) for Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find the better radiation therapy between intraoperative&#xD;
      radiotherapy (IORT) and concurrent chemoradiotherapy (CCRT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trial is funded by National High-tech R&amp;D Program (863 Program). The trial is prepared to&#xD;
      be registered on the clinicaltrail.gov.&#xD;
&#xD;
      Quality assurance plan: Every participant is enrolled or excluded by two practiced&#xD;
      investigators. And two investigators participated in all steps of the trail, including the&#xD;
      record of the data, and the investigators will compare the data. If the data is consistent,&#xD;
      the investigators would record the data; if not, the data would be checked and decided by the&#xD;
      two investigators. All the steps and data are site monitored and audited by the workers of&#xD;
      research and financial department of The First Affiliated Hospital of China Medical&#xD;
      University Data check: The investigators compare data entered into the registry against&#xD;
      predefined rules for range or consistency with other data fields in the registry. Source data&#xD;
      verification to assess the accuracy, completeness, or representativeness of registry data by&#xD;
      comparing the data to external data sources, including medical records and electronic case&#xD;
      report forms. Data dictionary that contains detailed descriptions of each variable used by&#xD;
      the registry, including the source of the variable, coding information, and normal ranges if&#xD;
      relevant. Standard Operating Procedures to address registry operations and analysis&#xD;
      activities, such as participants recruitment, data collection, data management, data&#xD;
      analysis, reporting for adverse events, and change management. All registry operations would&#xD;
      be done according to specific steps, and by two practiced investigators. Sample size&#xD;
      assessment to specify the number of participants or participant years necessary to&#xD;
      demonstrate an effect. According to the formula to differ advantages and disadvantages, the&#xD;
      investigators need at least 100 participants to take part in the trail. The investigators can&#xD;
      recruit about 120 participants every year according to previous experiences, so the&#xD;
      investigators should recruit at least for one years.&#xD;
&#xD;
      Plan for missing data: The investigators would collect as much data as possible, and the&#xD;
      investigators exclude the participants who cannot cooperate on recruitment. And the&#xD;
      investigators manage situations according to statistical principles where variables are&#xD;
      reported as missing, unavailable, &quot;non-reported,&quot; uninterpretable, or considered missing&#xD;
      because of data inconsistency or out-of-range results.&#xD;
&#xD;
      Statistical analysis plan: Kaplan-Meier method would be used to analyze the difference of&#xD;
      survival time between the two groups, and the local control rate of the two groups would be&#xD;
      compared by chi square test. Statistical analyses would be performed by using IBM SPSS&#xD;
      Statistics(version 20; IBM, Chicago, USA). The level of significance is defined as P &lt; 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2015</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <phase>N/A</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>Overal survival</measure>
    <time_frame>3 years</time_frame>
    <description>OS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease-specific survival</measure>
    <time_frame>3 years</time_frame>
    <description>DSS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>3 years</time_frame>
    <description>PFS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local control rate</measure>
    <time_frame>3 years</time_frame>
    <description>LCR</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Pancreatic Cancer Stage IV</condition>
  <arm_group>
    <arm_group_label>Intraoperative radiotherapy (IORT) Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Radiotherapy (Total dose: 18~22 Gy; Single dose: 18~22 Gy; Frequency: 1) + Sequential chemotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Concurrent Chemoradiotherapy (CCRT) Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three dimensional conformal radiation therapy (3D-CRT) (Total dose: 60 Gy; Single dose: 2 Gy; Frequency: 30) + Concurrent chemotherapy (Gemcitabine(GEM), 800 mg/m2 weekly on Day 1-21, Q28d; or S-1 orally, 400 mg/d, bid on Day 1-21, Q28d) + Sequential chemotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Intraoperative radiotherapy (IORT)</intervention_name>
    <description>Total dose: 18~22 Gy; Single dose: 18~22 Gy; Frequency: 1</description>
    <arm_group_label>Intraoperative radiotherapy (IORT) Group</arm_group_label>
    <other_name>IORT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sequential chemotherapy</intervention_name>
    <description>Sequential chemotherapy</description>
    <arm_group_label>Concurrent Chemoradiotherapy (CCRT) Group</arm_group_label>
    <arm_group_label>Intraoperative radiotherapy (IORT) Group</arm_group_label>
    <other_name>SC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Three dimensional conformal radiation therapy (3D-CRT)</intervention_name>
    <description>Total dose: 60 Gy; Single dose: 2 Gy; Frequency: 30</description>
    <arm_group_label>Concurrent Chemoradiotherapy (CCRT) Group</arm_group_label>
    <other_name>3D-CRT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Concurrent chemotherapy</intervention_name>
    <description>Gemcitabine (GEM), 800 mg/m2 weekly on Day 1-21, Q28d; or S-1 orally, 400 mg/d, bid on Day 1-21, Q28d</description>
    <arm_group_label>Concurrent Chemoradiotherapy (CCRT) Group</arm_group_label>
    <other_name>CC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed as locally advanced pancreatic cancer.&#xD;
&#xD;
          -  Cannot be treated by surgical resection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treated by chemotherapy or radiotherapy before.&#xD;
&#xD;
          -  With distant organ metastasis.&#xD;
&#xD;
          -  Cannot tolerate surgery (Intraoperative radiotherapy)&#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>Chengfeng Wang, B.A.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jianwei Zhang, Ph.D.</last_name>
    <phone>+8613581841816</phone>
    <email>panchutong@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shuisheng Zhang, M.D.</last_name>
    <phone>+8618001302322</phone>
    <email>thelifeofwater@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CancerIHCAMS</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianwei Zhang, Ph.D.</last_name>
      <phone>+8613581841816</phone>
      <email>panchutong@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Shuisheng Zhang, M.D.</last_name>
      <phone>+8618001302322</phone>
      <email>thelifeofwater@126.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>November 30, 2016</last_update_submitted>
  <last_update_submitted_qc>November 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Chengfeng Wang</investigator_full_name>
    <investigator_title>Director of Department of Abdominal Surgical Oncolgoy</investigator_title>
  </responsible_party>
  <keyword>Pancreatic cancer</keyword>
  <keyword>Intraoperative radiotherapy (IORT)</keyword>
  <keyword>Concurrent Chemoradiotherapy (CCRT)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02981641
org study id: 2012AA022701
nct id: NCT02981641
lead sponsor: 
has dmc: No
The purpose of this study is to find the better radiation therapy between intraoperative
      radiotherapy (IORT) and concurrent chemoradiotherapy (CCRT).
The trial is funded by National High-tech R&D Program (863 Program). The trial is prepared to
      be registered on the clinicaltrail.gov.

      Quality assurance plan: Every participant is enrolled or excluded by two practiced
      investigators. And two investigators participated in all steps of the trail, including the
      record of the data, and the investigators will compare the data. If the data is consistent,
      the investigators would record the data; if not, the data would be checked and decided by the
      two investigators. All the steps and data are site monitored and audited by the workers of
      research and financial department of The First Affiliated Hospital of China Medical
      University Data check: The investigators compare data entered into the registry against
      predefined rules for range or consistency with other data fields in the registry. Source data
      verification to assess the accuracy, completeness, or representativeness of registry data by
      comparing the data to external data sources, including medical records and electronic case
      report forms. Data dictionary that contains detailed descriptions of each variable used by
      the registry, including the source of the variable, coding information, and normal ranges if
      relevant. Standard Operating Procedures to address registry operations and analysis
      activities, such as participants recruitment, data collection, data management, data
      analysis, reporting for adverse events, and change management. All registry operations would
      be done according to specific steps, and by two practiced investigators. Sample size
      assessment to specify the number of participants or participant years necessary to
      demonstrate an effect. According to the formula to differ advantages and disadvantages, the
      investigators need at least 100 participants to take part in the trail. The investigators can
      recruit about 120 participants every year according to previous experiences, so the
      investigators should recruit at least for one years.

      Plan for missing data: The investigators would collect as much data as possible, and the
      investigators exclude the participants who cannot cooperate on recruitment. And the
      investigators manage situations according to statistical principles where variables are
      reported as missing, unavailable, "non-reported," uninterpretable, or considered missing
      because of data inconsistency or out-of-range results.

      Statistical analysis plan: Kaplan-Meier method would be used to analyze the difference of
      survival time between the two groups, and the local control rate of the two groups would be
      compared by chi square test. Statistical analyses would be performed by using IBM SPSS
      Statistics(version 20; IBM, Chicago, USA). The level of significance is defined as P < 0.05.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Overal survival
time frame: 3 years
description: OS
measure: Disease-specific survival
time frame: 3 years
description: DSS
measure: Progression-free survival
time frame: 3 years
description: PFS
measure: Local control rate
time frame: 3 years
description: LCR
arm group label: Intraoperative radiotherapy (IORT) Group
arm group type: Experimental
description: Radiotherapy (Total dose: 18~22 Gy; Single dose: 18~22 Gy; Frequency: 1) + Sequential chemotherapy
arm group label: Concurrent Chemoradiotherapy (CCRT) Group
arm group type: Experimental
description: Three dimensional conformal radiation therapy (3D-CRT) (Total dose: 60 Gy; Single dose: 2 Gy; Frequency: 30) + Concurrent chemotherapy (Gemcitabine(GEM), 800 mg/m2 weekly on Day 1-21, Q28d; or S-1 orally, 400 mg/d, bid on Day 1-21, Q28d) + Sequential chemotherapy
intervention type: Radiation
intervention name: Intraoperative radiotherapy (IORT)
description: Total dose: 18~22 Gy; Single dose: 18~22 Gy; Frequency: 1
arm group label: Intraoperative radiotherapy (IORT) Group
other name: IORT
intervention type: Drug
intervention name: Sequential chemotherapy
description: Sequential chemotherapy
arm group label: Concurrent Chemoradiotherapy (CCRT) Group
arm group label: Intraoperative radiotherapy (IORT) Group
other name: SC
intervention type: Radiation
intervention name: Three dimensional conformal radiation therapy (3D-CRT)
description: Total dose: 60 Gy; Single dose: 2 Gy; Frequency: 30
arm group label: Concurrent Chemoradiotherapy (CCRT) Group
other name: 3D-CRT
intervention type: Drug
intervention name: Concurrent chemotherapy
description: Gemcitabine (GEM), 800 mg/m2 weekly on Day 1-21, Q28d; or S-1 orally, 400 mg/d, bid on Day 1-21, Q28d
arm group label: Concurrent Chemoradiotherapy (CCRT) Group
other name: CC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Chengfeng Wang, B.A.
role: Principal Investigator
affiliation: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
last name: Jianwei Zhang, Ph.D.
phone: +8613581841816
email: panchutong@163.com
last name: Shuisheng Zhang, M.D.
phone: +8618001302322
email: thelifeofwater@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Chengfeng Wang
investigator title: Director of Department of Abdominal Surgical Oncolgoy
mesh term: Pancreatic Neoplasms
sharing ipd: No