<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/NCT03015168</url>
  </required_header>
  <id_info>
    <org_study_id>Radiation Oncology 201602</org_study_id>
    <nct_id>NCT03015168</nct_id>
  </id_info>
  <brief_title>Prognostic Value of Neutrophil-to-lymphocyte Ratio (NLR) on Rectal Cancer Patients</brief_title>
  <official_title>Prognostic Value of Neutrophil-to-lymphocyte Ratio (NLR) on Rectal Cancer Patients Who Received Capecitabine and Concurrent Intensity Modulated Radiotherapy (IMRT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>General Hospital of Ningxia Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>General Hospital of Ningxia Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We explored the relationship between NLR and grade 3 or higher treatment related small bowel&#xD;
      toxicity and treatment outcome of patients with rectal cancer undergoing capecitabine and&#xD;
      concurrent intensity modulated radiotherapy (IMRT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gender, age, stage of disease, and pathologic factors were retrospectively obtained from&#xD;
      electronic patient records. Staging was determined according to the classification&#xD;
      established by the American Joint Committee on Cancer (AJCC, 7th edition).Pelvic magnetic&#xD;
      resonance imaging (MRI) were used for pretreatment staging. All patients enrolled in this&#xD;
      study were treated with intensity modulated radiotherapy (IMRT) concurrent with capecitabine&#xD;
      (1600 mg/m2/d, administered twice daily for two weeks) before or after curative resection.&#xD;
      The mean radiation dose was 50 Gy with daily fraction of 2.0 Gy.&#xD;
&#xD;
      Acute treatment toxicity was scored according to the National Cancer Institute Common&#xD;
      Terminology Criteria for Adverse Events (CTCAE; version 3.0) and late toxicity was classified&#xD;
      according to the Late Effects in Normal Tissue-Subjective, Objective, Management and Analytic&#xD;
      (LENT-SOMA) system.&#xD;
&#xD;
      After the whole treatment procedure, all patients were subjected to a follow-up every three&#xD;
      months for the first two years, every six months for the next three years, and every year&#xD;
      thereafter. Physical examinations, routine blood test, serum carcinoembryonic antigen (CEA)&#xD;
      and Cancer Antigen 19-9 (CA-199) level were checked at each follow up. Chest, abdominal CT&#xD;
      scan and total colonoscopy were performed annually except the suspicion of tumor recurrence.&#xD;
&#xD;
      Overall survival (OS) time was defined from the date of completion of treatment to death from&#xD;
      any cause and progression-free survival (PFS) time was defined as the time from the date of&#xD;
      completion of therapy to the date of local recurrence or distant metastasis or death. Patient&#xD;
      follow-up was lasted until death or the cutoff date of January 2017.Blood sampling reports&#xD;
      from each enrolled patient were obtained within seven days before treatment. White blood cell&#xD;
      count, neutrophil, lymphocyte and platelet counts were examined. The NLR was calculated as&#xD;
      the absolute neutrophil count divided by the absolute lymphocyte count using baseline blood&#xD;
      test results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>overall survival</measure>
    <time_frame>5years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>grade 3 or higher treatment related small bowel toxicity</measure>
    <time_frame>5years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">117</enrollment>
  <condition>Rectal Cancer</condition>
  <condition>Prognosis</condition>
  <arm_group>
    <arm_group_label>Observational Group</arm_group_label>
    <description>Patients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>capecitabine and concurrent intensity modulated radiotherapy</intervention_name>
    <description>patients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy</description>
    <arm_group_label>Observational Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with rectal cancer undergoing capecitabine and concurrent intensity modulated&#xD;
        radiotherapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with locally advanced rectal cancer who received neoadjuvant or adjuvant&#xD;
             chemoradiotherapy at our hospital were enrolled in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with coexistent autoimmune diseases, infectious diseases, and lacking&#xD;
             baseline blood test records were excluded from this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yan-Yang Wang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>General Hospital of Ningxia Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>General Hospital of Ningxia Medical University</name>
      <address>
        <city>Yinchuan</city>
        <state>Ningxia</state>
        <zip>750004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 6, 2017</last_update_submitted>
  <last_update_submitted_qc>January 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2017</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>Capecitabine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03015168
org study id: Radiation Oncology 201602
nct id: NCT03015168
lead sponsor: 
has dmc: No
We explored the relationship between NLR and grade 3 or higher treatment related small bowel
      toxicity and treatment outcome of patients with rectal cancer undergoing capecitabine and
      concurrent intensity modulated radiotherapy (IMRT).
Gender, age, stage of disease, and pathologic factors were retrospectively obtained from
      electronic patient records. Staging was determined according to the classification
      established by the American Joint Committee on Cancer (AJCC, 7th edition).Pelvic magnetic
      resonance imaging (MRI) were used for pretreatment staging. All patients enrolled in this
      study were treated with intensity modulated radiotherapy (IMRT) concurrent with capecitabine
      (1600 mg/m2/d, administered twice daily for two weeks) before or after curative resection.
      The mean radiation dose was 50 Gy with daily fraction of 2.0 Gy.

      Acute treatment toxicity was scored according to the National Cancer Institute Common
      Terminology Criteria for Adverse Events (CTCAE; version 3.0) and late toxicity was classified
      according to the Late Effects in Normal Tissue-Subjective, Objective, Management and Analytic
      (LENT-SOMA) system.

      After the whole treatment procedure, all patients were subjected to a follow-up every three
      months for the first two years, every six months for the next three years, and every year
      thereafter. Physical examinations, routine blood test, serum carcinoembryonic antigen (CEA)
      and Cancer Antigen 19-9 (CA-199) level were checked at each follow up. Chest, abdominal CT
      scan and total colonoscopy were performed annually except the suspicion of tumor recurrence.

      Overall survival (OS) time was defined from the date of completion of treatment to death from
      any cause and progression-free survival (PFS) time was defined as the time from the date of
      completion of therapy to the date of local recurrence or distant metastasis or death. Patient
      follow-up was lasted until death or the cutoff date of January 2017.Blood sampling reports
      from each enrolled patient were obtained within seven days before treatment. White blood cell
      count, neutrophil, lymphocyte and platelet counts were examined. The NLR was calculated as
      the absolute neutrophil count divided by the absolute lymphocyte count using baseline blood
      test results.
observational model: Case-Only
time perspective: Retrospective
measure: overall survival
time frame: 5years
measure: grade 3 or higher treatment related small bowel toxicity
time frame: 5years
arm group label: Observational Group
description: Patients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy
intervention type: Radiation
intervention name: capecitabine and concurrent intensity modulated radiotherapy
description: patients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy
arm group label: Observational Group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yan-Yang Wang, M.D.
role: Principal Investigator
affiliation: General Hospital of Ningxia Medical University
facility: 
country: China
responsible party type: Sponsor
mesh term: Rectal Neoplasms
mesh term: Capecitabine
sharing ipd: No