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/NCT05984485</url>
    </required_header>
    <id_info>
      <org_study_id>GIHSYSU-TaLaR-02</org_study_id>
      <nct_id>NCT05984485</nct_id>
    </id_info>
    <brief_title>The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer</brief_title>
    <acronym>TaLaR-02</acronym>
    <official_title>TME vs TME+nCT in Low-risk LARC</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sun Yat-sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sun Yat-sen University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Comparative analysis of the clinical efficacy between primary Total Mesorectal Excision (TME)&#xD;
        surgery and neoadjuvant chemotherapy combined with TME surgery for low-risk locally advanced&#xD;
        rectal cancer. Randomly enrolling eligible patients into either the control group receiving&#xD;
        neoadjuvant chemotherapy combined with TME surgery or the experimental group receiving&#xD;
        primary TME surgery, and subsequently comparing the clinical outcomes of the two groups&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 5, 2022</start_date>
    <completion_date type="Anticipated">July 2028</completion_date>
    <primary_completion_date type="Anticipated">July 2028</primary_completion_date>
    <phase>Phase 3</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>
      <intervention_model_description>Primary TME&#xD;
  neoadjuvant chemotherapy plus TME</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>3-year Disease Free Survival</measure>
      <time_frame>3 years after surgery</time_frame>
      <description>Defined as the proportion of patients who did not experience any of the following events from the beginning of the randomized subgroup to the end of the third year, which included disease progression, local recurrence, distant metastasis, or second primary colorectal cancer, or death from any cause.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Distance from the inferior resection margin to the tumor</measure>
      <time_frame>Immediately after the surgery</time_frame>
      <description>The length between inferior resection margin and the tumor.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The status of circumferential margin</measure>
      <time_frame>Immediately after the surgery</time_frame>
      <description>When the distance from the tumor or malignant lymph node to the circumferential margin was ≤ 1 mm, it was recorded as a positive circumferential margin.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The status of distal resection margin</measure>
      <time_frame>Immediately after the surgery</time_frame>
      <description>When the distance from the tumor to the distal resection margin was ≤ 10 mm, it was recorded as a positive distal resection margin.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postiveoperative stay</measure>
      <time_frame>1 months after surgery</time_frame>
      <description>The days after surgery in the hospital</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Postoperative first feed</measure>
      <time_frame>1 months after surgery</time_frame>
      <description>The duration after surgery to first feed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Postoperative first gas</measure>
      <time_frame>1 months after surgery</time_frame>
      <description>The duration after surgery to first gas</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative pain</measure>
      <time_frame>1 months after surgery</time_frame>
      <description>Postoperative pain according to pain socres</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative anal function</measure>
      <time_frame>3 years after the surgery</time_frame>
      <description>Anal function would be based on wexner Incontinence score. A total score of less than ten is considered good, and a score of more than ten is considered poor.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life score</measure>
      <time_frame>3 years after the surgery</time_frame>
      <description>Quality of life score would be based on EORTC QoL C30 scale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>3-year overall survival</measure>
      <time_frame>3 years after the surgery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>5-year Disease Free Survival</measure>
      <time_frame>5 years after the surgery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>5-year overall survival</measure>
      <time_frame>5 years after the surgery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with treatment-related adverse events</measure>
      <time_frame>1 month after neoadjuvant chemotherapy</time_frame>
      <description>It would be assessed by CTCAE v4.0</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">766</enrollment>
    <condition>Rectal Cancer</condition>
    <arm_group>
      <arm_group_label>Primary total mesorectal excision</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with low-risk locally advanced rectal cancer received total mesorectal excision alone.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Neoadjuvant chemotherapy plus TME</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients with low-risk locally advanced rectal cancer received neoadjuvant chemotherapy and total mesorectal excision.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>neoadjuvant chemotherapy plus total mesorectal excision</intervention_name>
      <description>Neoadjuvant chemotherapy regimen recommended FOLFOX6, XELON, FOLFOX, mFOLFOX for 4-6 courses, and TME surgical treatment after preoperative tumor restaging 1-2 weeks after neoadjuvant chemotherapy.</description>
      <arm_group_label>Neoadjuvant chemotherapy plus TME</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>total mesorectal excision</intervention_name>
      <description>Standard total mesorectal excision</description>
      <arm_group_label>Primary total mesorectal excision</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Newly diagnosed patients, aged 18 to 75 years;&#xD;
  &#xD;
            2. Pathologically confirmed rectal adenocarcinoma;&#xD;
  &#xD;
            3. Distance of the lower margin of the rectal tumor lesion from the anal margin &lt;15cm;&#xD;
  &#xD;
            4. High-resolution MRI indicates low-risk locally advanced rectal cancer: T1-3bN1-2 or&#xD;
               T3aN0 or T3bN0; no involvement of the anal sphincter; negative mesorectal fascia (MRF)&#xD;
               status; negative extramural vascular invasion (EMVI); no cancer nodules;&#xD;
  &#xD;
            5. Exclusion of patients with non-local recurrence or distant metastases;&#xD;
  &#xD;
            6. Absence of synchronous colorectal multiple primary cancers;&#xD;
  &#xD;
            7. Adequate physical condition to tolerate surgery and neoadjuvant chemotherapy,&#xD;
               including cardiac, pulmonary, hepatic, and renal functions;&#xD;
  &#xD;
            8. The study physician assessed no difficulty in sphincter preservation;&#xD;
  &#xD;
            9. patients and their families will be willing to participate in this study and provide&#xD;
               written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with concurrent other malignancies or a history of malignant tumors in the&#xD;
               past;&#xD;
  &#xD;
            2. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, or&#xD;
               other conditions requiring emergency surgery;&#xD;
  &#xD;
            3. Patients with tumor invasion into the external sphincter or levator ani muscles, or&#xD;
               involvement of adjacent organs necessitating combined organ resection;&#xD;
  &#xD;
            4. Patients with poor anal function or fecal incontinence before surgery;&#xD;
  &#xD;
            5. Patients with a history of inflammatory bowel disease or familial adenomatous&#xD;
               polyposis;&#xD;
  &#xD;
            6. Patients recently diagnosed with other malignancies;&#xD;
  &#xD;
            7. Patients with ASA grade ≥ IV and/or ECOG performance status score &gt; 2;&#xD;
  &#xD;
            8. Patients with severe liver or kidney dysfunction, significant cardiopulmonary&#xD;
               impairment, coagulation disorders, or those with extreme underlying conditions unable&#xD;
               to tolerate surgery;&#xD;
  &#xD;
            9. Patients with a history of severe mental illness;&#xD;
  &#xD;
           10. Pregnant or lactating women;&#xD;
  &#xD;
           11. Patients with uncontrolled infections before surgery;&#xD;
  &#xD;
           12. Patients with other clinical or laboratory conditions, as determined by the&#xD;
               investigator, that render them unsuitable for participation in this trial.&#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>Liang Kang, PhD,MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sun yat-sen University, sixth affiliated hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Huashan Liu, MD. PhD</last_name>
      <phone>+8613560309975</phone>
      <email>liuhshan@mail2.sysu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ziwei Zeng, MD,PhD</last_name>
      <phone>+8615521161750</phone>
      <email>zengzw@mail2.sysu.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Daping Hospital, Amy Medeical Univerisity</name>
        <address>
          <city>Chongqing</city>
          <state>Chongqing</state>
          <zip>400042</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Weidong Tong, MD,PhD</last_name>
        <phone>+8613500321218</phone>
        <email>vdtong@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Sun yat-sen University, the Sixth Affiliated Hospital</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510655</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Liang Kang, MD, PhD</last_name>
        <phone>+8613602886833</phone>
        <email>kangl@mail.sysu.edu.cn</email>
      </contact>
      <contact_backup>
        <last_name>Huashan Liu, MD, PhD</last_name>
        <phone>+8613560309975</phone>
        <email>liuhshan@mail2.sysu.edu.cn</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of University of South China</name>
        <address>
          <city>Hengyang</city>
          <state>Hunan</state>
          <zip>421001</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jun Ouyang, MD,PhD</last_name>
        <phone>+8613973426200</phone>
        <email>1847039906@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shengjing Hospital of China Medical University</name>
        <address>
          <city>Shenyang</city>
          <state>Liaoning</state>
          <zip>110004</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hong Zhang, MD,PhD</last_name>
        <phone>+8618940257919</phone>
        <email>haojiubujian1203@sina.cn</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Xi'an Jiaotong University</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>710061</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yongchun Song, MD,PhD</last_name>
        <phone>+8618991232549</phone>
        <email>dr.songyongchun@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Affiliated Nanchong Central Hospital of North Sichuan Medical College</name>
        <address>
          <city>Nanchong</city>
          <state>Sichuan</state>
          <zip>637000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mingyang Ren, MD,PhD</last_name>
        <phone>+8613890756658</phone>
        <email>281746489@qq.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
      <investigator_full_name>Yanhong Deng</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Rectal cancer</keyword>
    <keyword>total mesorectal excision</keyword>
    <keyword>neoadjuvant chemotherapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rectal Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Reasonable requests can provide relevant data, but must be used anonymously</ipd_description>
    </patient_data>
    <!-- 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/NCT05984485
  org study id: GIHSYSU-TaLaR-02
  nct id: NCT05984485
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Comparative analysis of the clinical efficacy between primary Total Mesorectal Excision (TME)
        surgery and neoadjuvant chemotherapy combined with TME surgery for low-risk locally advanced
        rectal cancer. Randomly enrolling eligible patients into either the control group receiving
        neoadjuvant chemotherapy combined with TME surgery or the experimental group receiving
        primary TME surgery, and subsequently comparing the clinical outcomes of the two groups
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Primary TME
  neoadjuvant chemotherapy plus TME
  primary purpose: Treatment
  masking: None (Open Label)
  measure: 3-year Disease Free Survival
  time frame: 3 years after surgery
  description: Defined as the proportion of patients who did not experience any of the following events from the beginning of the randomized subgroup to the end of the third year, which included disease progression, local recurrence, distant metastasis, or second primary colorectal cancer, or death from any cause.
  measure: Distance from the inferior resection margin to the tumor
  time frame: Immediately after the surgery
  description: The length between inferior resection margin and the tumor.
  measure: The status of circumferential margin
  time frame: Immediately after the surgery
  description: When the distance from the tumor or malignant lymph node to the circumferential margin was ≤ 1 mm, it was recorded as a positive circumferential margin.
  measure: The status of distal resection margin
  time frame: Immediately after the surgery
  description: When the distance from the tumor to the distal resection margin was ≤ 10 mm, it was recorded as a positive distal resection margin.
  measure: Postiveoperative stay
  time frame: 1 months after surgery
  description: The days after surgery in the hospital
  measure: Time to Postoperative first feed
  time frame: 1 months after surgery
  description: The duration after surgery to first feed
  measure: Time to Postoperative first gas
  time frame: 1 months after surgery
  description: The duration after surgery to first gas
  measure: Postoperative pain
  time frame: 1 months after surgery
  description: Postoperative pain according to pain socres
  measure: Postoperative anal function
  time frame: 3 years after the surgery
  description: Anal function would be based on wexner Incontinence score. A total score of less than ten is considered good, and a score of more than ten is considered poor.
  measure: Quality of life score
  time frame: 3 years after the surgery
  description: Quality of life score would be based on EORTC QoL C30 scale.
  measure: 3-year overall survival
  time frame: 3 years after the surgery
  measure: 5-year Disease Free Survival
  time frame: 5 years after the surgery
  measure: 5-year overall survival
  time frame: 5 years after the surgery
  measure: Number of participants with treatment-related adverse events
  time frame: 1 month after neoadjuvant chemotherapy
  description: It would be assessed by CTCAE v4.0
  arm group label: Primary total mesorectal excision
  arm group type: Experimental
  description: Patients with low-risk locally advanced rectal cancer received total mesorectal excision alone.
  arm group label: Neoadjuvant chemotherapy plus TME
  arm group type: Active Comparator
  description: Patients with low-risk locally advanced rectal cancer received neoadjuvant chemotherapy and total mesorectal excision.
  intervention type: Procedure
  intervention name: neoadjuvant chemotherapy plus total mesorectal excision
  description: Neoadjuvant chemotherapy regimen recommended FOLFOX6, XELON, FOLFOX, mFOLFOX for 4-6 courses, and TME surgical treatment after preoperative tumor restaging 1-2 weeks after neoadjuvant chemotherapy.
  arm group label: Neoadjuvant chemotherapy plus TME
  intervention type: Procedure
  intervention name: total mesorectal excision
  description: Standard total mesorectal excision
  arm group label: Primary total mesorectal excision
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Liang Kang, PhD,MD
  role: Principal Investigator
  affiliation: Sun yat-sen University, sixth affiliated hospital
  last name: Huashan Liu, MD. PhD
  phone: +8613560309975
  email: liuhshan@mail2.sysu.edu.cn
  last name: Ziwei Zeng, MD,PhD
  phone: +8615521161750
  email: zengzw@mail2.sysu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Sun Yat-sen University
  investigator full name: Yanhong Deng
  investigator title: Professor
  mesh term: Rectal Neoplasms
  sharing ipd: Undecided
  ipd description: Reasonable requests can provide relevant data, but must be used anonymously