<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/NCT04499586</url>
  </required_header>
  <id_info>
    <org_study_id>FDRT-R006</org_study_id>
    <nct_id>NCT04499586</nct_id>
  </id_info>
  <brief_title>A Study of Radiotherapy Combined With Raltitrexed and Irinotecan in Metastatic or Locally Recurrent Colorectal Cancer</brief_title>
  <official_title>A Phase II Trial of Radiotherapy Combined With Raltitrexed and Irinotecan(CPT-11) in Patients With Metastatic or Locally Recurrent Colorectal 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 effectiveness of radiotherapy combined with raltitrexed and&#xD;
      irinotecan in treating patients who have metastatic or locally recurrent colorectal cancer&#xD;
      that has not responded to fluorouracil. The patients will receive radiotherapy combined with&#xD;
      raltitrexed and irinotecan, and then the surgeons will evaluate whether they should receive a&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">August 1, 2020</primary_completion_date>
  <phase>Phase 2</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>ORR(Objective Response Rate) includes CR(Complete Rate) and PR(Partial Rate)</measure>
    <time_frame>20 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>DCR(Disease Control Rate)</measure>
    <time_frame>20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS(Progression Free Survival)</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0</measure>
    <time_frame>20 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Recurrent Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Radiotherapy Combined With Raltitrexed and Irinotecan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each cycle lasts 3 weeks. Administration of Raltitrexed and Irinotecan weekly followed by a 2 week 'rest' period with no drug given. Raltitrexed is given by IV infusion at a dose of 3mg/m2. Irinotecan is given by IV infusion at a dose of 80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7).Radiation: 45-55Gy/25-30Fx</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Radiotherapy Combined With Raltitrexed and Irinotecan</intervention_name>
    <description>Each cycle lasts 3 weeks. Raltitrexed: 3mg/m2 per week. Irinotecan : 80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7) per week. Radiation: 45-55Gy/25-30Fx</description>
    <arm_group_label>Radiotherapy Combined With Raltitrexed and Irinotecan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven metastatic, advanced, or locally recurrent fluorouracil (5-FU)&#xD;
             and oxaliplatin refractory adenocarcinoma of the colon or rectum; Progression of&#xD;
             disease within 6 months of receiving adjuvant 5-FU and oxaliplatin chemotherapy OR&#xD;
             Progression of disease during or following completion of 5-FU and oxaliplatin&#xD;
             chemotherapy for metastatic disease&#xD;
&#xD;
          -  Evaluable lesions with indications of radiotherapy&#xD;
&#xD;
          -  No other metastatic lesions in the radiation field&#xD;
&#xD;
          -  Karnofsky Performance Status&gt;=70&#xD;
&#xD;
          -  UGT1A1*28 6/6 or 6/7&#xD;
&#xD;
          -  Subject blood routine and biochemical indicators meet the following criteria:&#xD;
             hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; Alanine&#xD;
             transaminase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of&#xD;
             normal; alkaline phosphatase (ALP) ≤2.5 times the normal upper limit; serum total&#xD;
             bilirubin &lt;1.5 times the normal upper limit; serum creatinine &lt;1 times the normal&#xD;
             upper limit; serum albumin ≥ 30g / L&#xD;
&#xD;
          -  Able to follow the protocol during the study period&#xD;
&#xD;
          -  Sign the inform consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  If there is an uncontrolled history of epilepsy, central nervous system disease or&#xD;
             mental disorder, the investigator may determine that the clinical severity may hinder&#xD;
             the signing of informed consent or affect the patient's oral medication compliance.&#xD;
&#xD;
          -  Clinically severe (ie, active) heart disease, such as symptomatic coronary heart&#xD;
             disease, New York Heart Association (NYHA) class II or more severe congestive heart&#xD;
             failure or severe arrhythmia requiring medication intervention (see appendix 12), or a&#xD;
             history of myocardial infarction in the last 12 months&#xD;
&#xD;
          -  Organ transplantation requires immunosuppressive therapy&#xD;
&#xD;
          -  Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant&#xD;
             diseases&#xD;
&#xD;
          -  Anyone who is allergic to any research medication&#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, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200023</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</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>Recurrent Colorectal Cancer</keyword>
  <keyword>Irinotecan</keyword>
  <keyword>Raltitrexed</keyword>
  <keyword>Chemoradiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irinotecan</mesh_term>
    <mesh_term>Raltitrexed</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/NCT04499586
org study id: FDRT-R006
nct id: NCT04499586
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study evaluates the effectiveness of radiotherapy combined with raltitrexed and
      irinotecan in treating patients who have metastatic or locally recurrent colorectal cancer
      that has not responded to fluorouracil. The patients will receive radiotherapy combined with
      raltitrexed and irinotecan, and then the surgeons will evaluate whether they should receive a
      surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: ORR(Objective Response Rate) includes CR(Complete Rate) and PR(Partial Rate)
time frame: 20 weeks
measure: DCR(Disease Control Rate)
time frame: 20 weeks
measure: PFS(Progression Free Survival)
time frame: 24 months
measure: the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
time frame: 20 weeks
arm group label: Radiotherapy Combined With Raltitrexed and Irinotecan
arm group type: Experimental
description: Each cycle lasts 3 weeks. Administration of Raltitrexed and Irinotecan weekly followed by a 2 week 'rest' period with no drug given. Raltitrexed is given by IV infusion at a dose of 3mg/m2. Irinotecan is given by IV infusion at a dose of 80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7).Radiation: 45-55Gy/25-30Fx
intervention type: Combination Product
intervention name: Radiotherapy Combined With Raltitrexed and Irinotecan
description: Each cycle lasts 3 weeks. Raltitrexed: 3mg/m2 per week. Irinotecan : 80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7) per week. Radiation: 45-55Gy/25-30Fx
arm group label: Radiotherapy Combined With Raltitrexed and Irinotecan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Zhen Zhang, MD
role: Principal Investigator
affiliation: Fudan University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Zhu Ji
investigator title: professor
mesh term: Colorectal Neoplasms
mesh term: Recurrence
mesh term: Irinotecan
mesh term: Raltitrexed