xml: <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/NCT06035133</url>
    </required_header>
    <id_info>
      <org_study_id>K202108-27</org_study_id>
      <nct_id>NCT06035133</nct_id>
    </id_info>
    <brief_title>Treatment of Low Locally Advanced Rectal Cancer With Radiotherapy Removal TNT Plus Neoadjuvant Therapy</brief_title>
    <official_title>One Arm Exploratory Trial of Efficacy and Safety of TNT Plus Mode With Neoadjuvant Radiotherapy in the Treatment of Locally Advanced Medium-low Rectal Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tang-Du Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tang-Du Hospital</source>
    <oversight_info>
      <has_dmc>No</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>
        (1) To evaluate the oncological effects of Treatment of low locally advanced rectal cancer&#xD;
        with radiotherapy removal TNT plus neoadjuvant therapy TNT plus mode on TRG, Anal sphincter&#xD;
        preservation surgery rate / rectal preservation surgery rate, cCR rate, pCR rate and other&#xD;
        oncological effects in patients with middle and low LARC; (2) Evaluate the R0 resection rate,&#xD;
        LARS score, urination function and sexual function score, local recurrence rate, and 3-year&#xD;
        DFS and OS of Treatment of low locally advanced rectal cancer with radiotherapy removal TNT&#xD;
        plus neoadjuvant therapy TNT plus mode, resolve the current dispute about the Treatment of&#xD;
        low locally advanced rectal cancer with radiotherapy removal TNT plus neoadjuvant therapy TNT&#xD;
        treatment mode of LARC, provide a new mode for LARC treatment, and hopefully rewrite the&#xD;
        diagnosis and treatment guidelines for rectal cancer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 10, 2023</start_date>
    <completion_date type="Anticipated">November 10, 2027</completion_date>
    <primary_completion_date type="Anticipated">November 10, 2024</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>tumor regression grading, TRG</measure>
      <time_frame>one month after surgery</time_frame>
      <description>Reference resist 1.1 rating</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">213</enrollment>
    <condition>Rectal Cancer</condition>
    <arm_group>
      <arm_group_label>radiotherapy removal TNT plus group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Six induction chemotherapy rounds of the CapeOX regimen were administered. RAS, BRAF, and MSI were found when the first patients were examined. Patients were given CapeOX + cetuximab for RAS wild-type patients, CapeOX + bevacizumab for RAS mutant patients, and CapeOX + cetuximab for MSI-H patients. The CapeOX regimen: Oxaliplatin 130 mg/m2, intravenous injection, day 1; capecitabine 1000 mg/m2, oral, twice daily, days 1 through 14; once every 3 weeks. A surgical procedure was carried out two weeks after consolidation chemotherapy ended.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>CapeOX + cetuximab</intervention_name>
      <description>CapeOX + cetuximab for RAS wild-type patients and CapeOX + cetuximab for MSI-H patients. The CapeOX regimen: Oxaliplatin 130 mg/m2, intravenous injection, day 1; capecitabine 1000 mg/m2, oral, twice daily, days 1 through 14; once every 3 weeks.</description>
      <arm_group_label>radiotherapy removal TNT plus group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>CapeOX + bevacizumab</intervention_name>
      <description>CapeOX + bevacizumab for RAS mutant patients. The CapeOX regimen: Oxaliplatin 130 mg/m2, intravenous injection, day 1; capecitabine 1000 mg/m2, oral, twice daily, days 1 through 14; once every 3 weeks.</description>
      <arm_group_label>radiotherapy removal TNT plus group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>radiotherapy</intervention_name>
      <description>radiotherapy</description>
      <arm_group_label>radiotherapy removal TNT plus group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged between 18 and 70;&#xD;
  &#xD;
            -  Histologically confirmed adenocarcinoma of rectum;&#xD;
  &#xD;
            -  The distance from the lower edge of the tumor to the anus is ≤ 10cm;&#xD;
  &#xD;
            -  ECOG score ≤ 1;&#xD;
  &#xD;
            -  Have not received any anti-tumor treatment before;&#xD;
  &#xD;
            -  Preoperative abdominal enhanced CT or MRI showed cT4, cN0-2; M0 chest and abdomen CT&#xD;
               showed no obvious metastasis. (Note: PET-CT is recommended when small nodules can not&#xD;
               be identified by liver or lung CT, and can still be included in the group when&#xD;
               considering the possibility of metastasis)&#xD;
  &#xD;
            -  Hematological indicators and liver and kidney function within 7 days are within the&#xD;
               normal range;&#xD;
  &#xD;
            -  Sign the informed consent form and be able to follow the research and /or follow-up&#xD;
               procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have serious basic diseases, such as heart disease, renal failure, severe liver&#xD;
               failure or liver failure, coagulation dysfunction, etc; Postoperative recurrence of&#xD;
               colorectal cancer;&#xD;
  &#xD;
            -  The patient had a history of malignant tumor within 5 years;&#xD;
  &#xD;
            -  Pregnant or lactating women;&#xD;
  &#xD;
            -  The patient has a history of adjuvant radiotherapy for other system diseases, and&#xD;
               surgical contraindications, so it is not suitable for surgery;&#xD;
  &#xD;
            -  The patient has had radiotherapy and chemotherapy records before this visit;&#xD;
  &#xD;
            -  Distant metastasis was found during operation;&#xD;
  &#xD;
            -  Patients with poor radiotherapy compliance and difficult cooperation;&#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_contact>
      <last_name>Nan Wang, Dr</last_name>
      <phone>15719286297</phone>
      <email>wangnandoc@163.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>December 22, 2022</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rectal Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bevacizumab</mesh_term>
      <mesh_term>Cetuximab</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06035133
  org study id: K202108-27
  nct id: NCT06035133
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  (1) To evaluate the oncological effects of Treatment of low locally advanced rectal cancer
        with radiotherapy removal TNT plus neoadjuvant therapy TNT plus mode on TRG, Anal sphincter
        preservation surgery rate / rectal preservation surgery rate, cCR rate, pCR rate and other
        oncological effects in patients with middle and low LARC; (2) Evaluate the R0 resection rate,
        LARS score, urination function and sexual function score, local recurrence rate, and 3-year
        DFS and OS of Treatment of low locally advanced rectal cancer with radiotherapy removal TNT
        plus neoadjuvant therapy TNT plus mode, resolve the current dispute about the Treatment of
        low locally advanced rectal cancer with radiotherapy removal TNT plus neoadjuvant therapy TNT
        treatment mode of LARC, provide a new mode for LARC treatment, and hopefully rewrite the
        diagnosis and treatment guidelines for rectal cancer.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: tumor regression grading, TRG
  time frame: one month after surgery
  description: Reference resist 1.1 rating
  arm group label: radiotherapy removal TNT plus group
  arm group type: Experimental
  description: Six induction chemotherapy rounds of the CapeOX regimen were administered. RAS, BRAF, and MSI were found when the first patients were examined. Patients were given CapeOX + cetuximab for RAS wild-type patients, CapeOX + bevacizumab for RAS mutant patients, and CapeOX + cetuximab for MSI-H patients. The CapeOX regimen: Oxaliplatin 130 mg/m2, intravenous injection, day 1; capecitabine 1000 mg/m2, oral, twice daily, days 1 through 14; once every 3 weeks. A surgical procedure was carried out two weeks after consolidation chemotherapy ended.
  intervention type: Drug
  intervention name: CapeOX + cetuximab
  description: CapeOX + cetuximab for RAS wild-type patients and CapeOX + cetuximab for MSI-H patients. The CapeOX regimen: Oxaliplatin 130 mg/m2, intravenous injection, day 1; capecitabine 1000 mg/m2, oral, twice daily, days 1 through 14; once every 3 weeks.
  arm group label: radiotherapy removal TNT plus group
  intervention type: Drug
  intervention name: CapeOX + bevacizumab
  description: CapeOX + bevacizumab for RAS mutant patients. The CapeOX regimen: Oxaliplatin 130 mg/m2, intravenous injection, day 1; capecitabine 1000 mg/m2, oral, twice daily, days 1 through 14; once every 3 weeks.
  arm group label: radiotherapy removal TNT plus group
  intervention type: Radiation
  intervention name: radiotherapy
  description: radiotherapy
  arm group label: radiotherapy removal TNT plus group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Nan Wang, Dr
  phone: 15719286297
  email: wangnandoc@163.com
  responsible party type: Sponsor
  mesh term: Rectal Neoplasms
  mesh term: Bevacizumab
  mesh term: Cetuximab