<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/NCT03009253</url>
  </required_header>
  <id_info>
    <org_study_id>GHGI061</org_study_id>
    <nct_id>NCT03009253</nct_id>
  </id_info>
  <brief_title>Translational Research on Locally Advanced Pancreatic Adenocarcinoma</brief_title>
  <acronym>TRLAPA</acronym>
  <official_title>Translational Research on Locally Advanced Pancreatic Adenocarcinoma</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find the best neoadjuvant therapy for pancreatic&#xD;
      adenocarcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trial is prepared to be registered on the clinicaltrail.gov. Quality assurance plan:&#xD;
      Every participant is enrolled or excluded by two practiced investigators. And two&#xD;
      investigators participated in all steps of the trail, including the record of the data, and&#xD;
      the investigators will compare the data. If the data is consistent,the investigators would&#xD;
      record the data; if not, the data would be checked and decided by the two investigators. All&#xD;
      the steps and data are site monitored and audited by the workers of research and financial&#xD;
      department of National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences.&#xD;
&#xD;
      Data check: The investigators compare data entered into the registry against predefined rules&#xD;
      for range or consistency with other data fields in the registry.Source data verification to&#xD;
      assess the accuracy, completeness, or representativeness of registry data by comparing the&#xD;
      data to external data sources, including medical records and electronic case report forms.&#xD;
&#xD;
      Data dictionary that contains detailed descriptions of each variable used by the&#xD;
      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.&#xD;
&#xD;
      Sample size assessment to specify the number of participants or participant years necessary&#xD;
      to demonstrate an effect. According to the formula to differ advantages and disadvantages,&#xD;
      the investigators need at least 80 participants to take part in the trail.&#xD;
&#xD;
      The investigators can recruit about 20 participants every year according to previous&#xD;
      experiences, so the investigators should recruit at least for two 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>July 2015</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>translational resection rate</measure>
    <time_frame>half a year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>progression-free survival</measure>
    <time_frame>2 years</time_frame>
    <description>PFS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local control rate</measure>
    <time_frame>2 years</time_frame>
    <description>LCR</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>Concurrent chemoradiotherapy(CCRT) Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Concurrent chemoradiotherapy (Total dose: 30-40 Gy; Single dose: 3-4 Gy; Frequency: 10; S-1 orally (80 mg/m2/d),2 weeks) Followed by chemotherapy: Gemcitabine(GEM), 1000 mg/m2 ,Day 1,8 ); taking S-1 orally (80 mg/m2/d, bid on Day 1-14, Q21d, 3 cycles)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chemotherapy Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chemotherapy (Gemcitabine(GEM), 1000 mg/m2 ,Day 1,8 ); taking S-1 orally (80 mg/m2/d, bid on Day 1-14, Q21d, 3 cycles)&#xD;
Followed by Concurrent chemoradiotherapy:&#xD;
(Total dose: 30-40 Gy; Single dose: 3-4 Gy; Frequency: 10; S-1 orally (80 mg/m2/d),2 weeks)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>order of treatment</intervention_name>
    <description>the 2 arms have different orders of treatment,participants in arm A accept concurrent chemoradiotherapy at first and then accept evalution for surgery.In arm B,participants accept concurrent chemoradiotherapy at first and then accept evalution for surgery.</description>
    <arm_group_label>Chemotherapy Group</arm_group_label>
    <arm_group_label>Concurrent chemoradiotherapy(CCRT) Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  have cytologic or pathological proof of pancreatic adenocarcinoma without surgery&#xD;
             contraindication score of ECOG is between 0 and 1 evaluation of CT is unresectable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  metastatic pancreatc adenocarcinoma malignant tumors history allergic to 5-FU have&#xD;
             difficulty in swallowing joined other clinical trails cardiac and renal disease active&#xD;
             infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chengfeng Wang, B.A.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Investigator CancerIHCAMS</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xu Che, M.D</last_name>
    <phone>8610-87787120</phone>
    <email>xu.che@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yunmian Chu, M.D.</last_name>
    <phone>+8618101333727</phone>
    <email>chuyunmian@foxmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cancer Institute and Hospital ,China Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>10021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xu Che, M.D.</last_name>
      <phone>8610-87787120</phone>
      <email>xu.che@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 31, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>December 31, 2016</last_update_submitted>
  <last_update_submitted_qc>December 31, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</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 pancreatic and gastric surgery</investigator_title>
  </responsible_party>
  <keyword>Neoadjuvant therapy</keyword>
  <keyword>Pancreatic Cancer</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>
  <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/NCT03009253
org study id: GHGI061
nct id: NCT03009253
lead sponsor: 
has dmc: Yes
The purpose of this study is to find the best neoadjuvant therapy for pancreatic
      adenocarcinoma.
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 National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences.

      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 80 participants to take part in the trail.

      The investigators can recruit about 20 participants every year according to previous
      experiences, so the investigators should recruit at least for two 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: translational resection rate
time frame: half a year
measure: progression-free survival
time frame: 2 years
description: PFS
measure: Local control rate
time frame: 2 years
description: LCR
arm group label: Concurrent chemoradiotherapy(CCRT) Group
arm group type: Experimental
description: Concurrent chemoradiotherapy (Total dose: 30-40 Gy; Single dose: 3-4 Gy; Frequency: 10; S-1 orally (80 mg/m2/d),2 weeks) Followed by chemotherapy: Gemcitabine(GEM), 1000 mg/m2 ,Day 1,8 ); taking S-1 orally (80 mg/m2/d, bid on Day 1-14, Q21d, 3 cycles)
arm group label: Chemotherapy Group
arm group type: Experimental
description: Chemotherapy (Gemcitabine(GEM), 1000 mg/m2 ,Day 1,8 ); taking S-1 orally (80 mg/m2/d, bid on Day 1-14, Q21d, 3 cycles)
Followed by Concurrent chemoradiotherapy:
(Total dose: 30-40 Gy; Single dose: 3-4 Gy; Frequency: 10; S-1 orally (80 mg/m2/d),2 weeks)
intervention type: Other
intervention name: order of treatment
description: the 2 arms have different orders of treatment,participants in arm A accept concurrent chemoradiotherapy at first and then accept evalution for surgery.In arm B,participants accept concurrent chemoradiotherapy at first and then accept evalution for surgery.
arm group label: Chemotherapy Group
arm group label: Concurrent chemoradiotherapy(CCRT) Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Chengfeng Wang, B.A.
role: Principal Investigator
affiliation: Investigator CancerIHCAMS
last name: Xu Che, M.D
phone: 8610-87787120
email: xu.che@hotmail.com
last name: Yunmian Chu, M.D.
phone: +8618101333727
email: chuyunmian@foxmail.com
facility: 
status: Recruiting
contact: 
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 pancreatic and gastric surgery
mesh term: Adenocarcinoma
mesh term: Pancreatic Neoplasms
sharing ipd: Undecided