<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/NCT03824899</url>
  </required_header>
  <id_info>
    <org_study_id>FDRT-010</org_study_id>
    <nct_id>NCT03824899</nct_id>
  </id_info>
  <brief_title>UGT1A1 Combined With Pharmacokinetics of SN-38 in CPT-11-based CRT in Patients With Advanced Rectal Cancer</brief_title>
  <official_title>The Application of UGT1A1 Genotype Combined With Pharmacokinetics of SN-38 in the Detection of Irinotecan-based Neoadjuvant Chemoradiotherapy in Patients With Advanced Rectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study evaluates the associations between peak and valley concentrations of SN-38 with the&#xD;
      efficacy and adverse effects of advanced rectal cancer patients carrying genotype (TA) 6&#xD;
      /(TA) 6 or (TA) 6 /(TA) 7 after neoadjuvant chemoradiotherapy with CPT-11.All participants&#xD;
      will be scheduled to receive surgery 6-8 weeks after the completion of CRT. The primary end&#xD;
      point are toxicity and pCR rate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 10, 2018</start_date>
  <completion_date type="Anticipated">May 2020</completion_date>
  <primary_completion_date type="Anticipated">May 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0</measure>
    <time_frame>During the chemoradiation weekly，assessed up to 5 weeks</time_frame>
    <description>the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pathological response rate</measure>
    <time_frame>Surgery scheduled 6-8 weeks after the end of chemoradiation</time_frame>
    <description>pathological complete response (pCR) was defined no viable cancer cell under the examination of surgical resection specimen.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Locally Advanced Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>CRT group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients With Advanced Rectal Cancer receiving CPT-11-based CRT and blood concentration check</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood concentration check</intervention_name>
    <description>Blood concentration check：the plasma concentration of SN-38 was detected by HPLC (high-performance liquid chromatography) at 1.5 h and 49.0 h after CPT-11 infusion</description>
    <arm_group_label>CRT group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pathological confirmed adenocarcinoma&#xD;
&#xD;
          -  clinical stage T3-4 and/or N+&#xD;
&#xD;
          -  the distance from anal verge less than 12 cm&#xD;
&#xD;
          -  without distance metastases&#xD;
&#xD;
          -  performance status score: 0~1&#xD;
&#xD;
          -  UGT1A1*28 6/6 or 6/7&#xD;
&#xD;
          -  without previous anti-cancer therapy&#xD;
&#xD;
          -  sign the inform consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy or breast-feeding women&#xD;
&#xD;
          -  serious medical illness&#xD;
&#xD;
          -  baseline blood and biochemical indicators do not meet the following criteria:&#xD;
             neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN&#xD;
&#xD;
          -  DPD deficiency&#xD;
&#xD;
          -  UGT1A1*28 7/7&#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>Zhen Zhang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ji Zhu, PhD</last_name>
    <phone>+86-2164175590</phone>
    <phone_ext>81607</phone_ext>
    <email>leo.zhu@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ji Zhu, PhD</last_name>
      <email>leo.zhu@126.com</email>
    </contact>
    <investigator>
      <last_name>Zhen Zhang, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ji Zhu, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 20, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Zhu Ji</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>neoadjuvant chemoradiotherapy</keyword>
  <keyword>irinotecan</keyword>
  <keyword>SN-38</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
  </condition_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/NCT03824899
org study id: FDRT-010
nct id: NCT03824899
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study evaluates the associations between peak and valley concentrations of SN-38 with the
      efficacy and adverse effects of advanced rectal cancer patients carrying genotype (TA) 6
      /(TA) 6 or (TA) 6 /(TA) 7 after neoadjuvant chemoradiotherapy with CPT-11.All participants
      will be scheduled to receive surgery 6-8 weeks after the completion of CRT. The primary end
      point are toxicity and pCR rate.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
time frame: During the chemoradiation weekly，assessed up to 5 weeks
description: the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
measure: pathological response rate
time frame: Surgery scheduled 6-8 weeks after the end of chemoradiation
description: pathological complete response (pCR) was defined no viable cancer cell under the examination of surgical resection specimen.
arm group label: CRT group
arm group type: Experimental
description: Patients With Advanced Rectal Cancer receiving CPT-11-based CRT and blood concentration check
intervention type: Diagnostic Test
intervention name: Blood concentration check
description: Blood concentration check：the plasma concentration of SN-38 was detected by HPLC (high-performance liquid chromatography) at 1.5 h and 49.0 h after CPT-11 infusion
arm group label: CRT group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Zhen Zhang, PhD
role: Principal Investigator
affiliation: Fudan University
last name: Ji Zhu, PhD
phone: +86-2164175590
phone ext: 81607
email: leo.zhu@126.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Zhu Ji
investigator title: professor
mesh term: Rectal Neoplasms