<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/NCT03238261</url>
  </required_header>
  <id_info>
    <org_study_id>C41030310-023</org_study_id>
    <nct_id>NCT03238261</nct_id>
  </id_info>
  <brief_title>Chemotherapy / Radiotherapy in Uterine Cervical Neoplasms</brief_title>
  <official_title>CHEMOTHERAPY AND CONCOMITANT RADIOTHERAPY VS. RADIOTHERAPY IN THE TREATMENT OF PATIENTS WITH STAGE IIIB UTERINE CANCER</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Cancerologia, Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Nacional de Cancerologia, Columbia</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>
      Compare the use of radiotherapy and concomitant chemotherapy, with the single use of&#xD;
      radiotherapy in the treatment of patients with stage IIIB uterine cancer, having as an&#xD;
      outcome the three year survival rate, the disease free survival rate, the locoregional&#xD;
      control of the disease and the security of the treatments provided.&#xD;
&#xD;
      Specific objectives&#xD;
&#xD;
        1. Describe and compare the demographic and clinical characteristics of both groups.&#xD;
&#xD;
        2. Compare the three year survival rate in both groups.&#xD;
&#xD;
        3. Compare the response to treatment in terms of locoregional control of the disease.&#xD;
&#xD;
        4. Compare the appearance of severe and non severe adverse events directly related to the&#xD;
           treatment in both intervention groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inclusion criteria Women between 18 and 80 years old, diagnosed with uterine squamous cell&#xD;
      cancer or stage IIIB adenocarcinoma (FIGO) with ECOG equal 1 or less and a Karnofsky equal or&#xD;
      more than 70%.&#xD;
&#xD;
      Exclusion criteria Having a concomitant or previous neoplasia, except for patients with skin&#xD;
      tumors not associated to melanomas, platelet count under 100.000, hemoglobin levels of 10&#xD;
      gr/dl or above before starting the first radiotherapy session, patients with recurrent&#xD;
      invasive uterine carcinoma, patients with compromised para aortic lymph nodes, patients with&#xD;
      active and non controlled pelvic infection by the beginning of the treatment, creatinine&#xD;
      depuration less than 45 ml/min confirmed with glomerular filtration rate less than 45 ml/min,&#xD;
      neutrophils count less than 1,500/ml, and pregnant or nursing woman.&#xD;
&#xD;
      Analysis The descriptive statistical analysis will be made with proportions for the&#xD;
      categorical variables, and for numerical variables will be made with averages, medians,&#xD;
      standard deviations and ranges. The comparison between categorical variables will be made&#xD;
      with square Ji proof or exact Fisher's proof when square Ji proof doesn't meet the criteria.&#xD;
      The comparison among continuous variables with normal distribution will be established with T&#xD;
      student distribution proof or ANOVA, and Mann-Whitnew or Kruskall proofs will be used for&#xD;
      variables that doesn't have this type of distribution.&#xD;
&#xD;
      For the three survival rate, the Kaplan Meier method will be applied, and the survival curves&#xD;
      will be compared with the logarithmic range proof. The Cox proportional hazard model is going&#xD;
      to be used for the multivariate analysis and to stablish reasons. Additionally 5 interim&#xD;
      analysis will be made.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2007</start_date>
  <completion_date type="Actual">May 1, 2016</completion_date>
  <primary_completion_date type="Actual">February 1, 2012</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survival rate</measure>
    <time_frame>3 years</time_frame>
    <description>the disease free survival rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The response to treatment in terms of locoregional control of the disease</measure>
    <time_frame>3 years</time_frame>
    <description>efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Events adverse</measure>
    <time_frame>3 years</time_frame>
    <description>4. Compare the appearance of severe and non severe adverse events directly related to the treatment in both intervention groups.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">147</enrollment>
  <condition>Uterine Cervical Neoplasms</condition>
  <arm_group>
    <arm_group_label>Chemotherapy and concomitant radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Radiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Chemotherapy and concomitant radiotherapy</intervention_name>
    <description>Radiotherapy (teletherapy + high or low rate brachytherapy)</description>
    <arm_group_label>Chemotherapy and concomitant radiotherapy</arm_group_label>
    <arm_group_label>Radiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women between 18 and 80 years old, diagnosed with uterine squamous cell cancer or&#xD;
             stage IIIB adenocarcinoma (FIGO) with ECOG equal 1 or less and a Karnofsky equal or&#xD;
             more than 70%.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having a concomitant or previous neoplasia, except for patients with skin tumors not&#xD;
             associated to melanomas, platelet count under 100.000, hemoglobin levels of 10 gr/dl&#xD;
             or above before starting the first radiotherapy session, patients with recurrent&#xD;
             invasive uterine carcinoma, patients with compromised para aortic lymph nodes,&#xD;
             patients with active and non controlled pelvic infection by the beginning of the&#xD;
             treatment, creatinine depuration less than 45 ml/min confirmed with glomerular&#xD;
             filtration rate less than 45 ml/min, neutrophils count less than 1,500/ml, and&#xD;
             pregnant or nursing woman.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 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>Neoplasms</mesh_term>
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_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/NCT03238261
org study id: C41030310-023
nct id: NCT03238261
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Compare the use of radiotherapy and concomitant chemotherapy, with the single use of
      radiotherapy in the treatment of patients with stage IIIB uterine cancer, having as an
      outcome the three year survival rate, the disease free survival rate, the locoregional
      control of the disease and the security of the treatments provided.

      Specific objectives

        1. Describe and compare the demographic and clinical characteristics of both groups.

        2. Compare the three year survival rate in both groups.

        3. Compare the response to treatment in terms of locoregional control of the disease.

        4. Compare the appearance of severe and non severe adverse events directly related to the
           treatment in both intervention groups.
Inclusion criteria Women between 18 and 80 years old, diagnosed with uterine squamous cell
      cancer or stage IIIB adenocarcinoma (FIGO) with ECOG equal 1 or less and a Karnofsky equal or
      more than 70%.

      Exclusion criteria Having a concomitant or previous neoplasia, except for patients with skin
      tumors not associated to melanomas, platelet count under 100.000, hemoglobin levels of 10
      gr/dl or above before starting the first radiotherapy session, patients with recurrent
      invasive uterine carcinoma, patients with compromised para aortic lymph nodes, patients with
      active and non controlled pelvic infection by the beginning of the treatment, creatinine
      depuration less than 45 ml/min confirmed with glomerular filtration rate less than 45 ml/min,
      neutrophils count less than 1,500/ml, and pregnant or nursing woman.

      Analysis The descriptive statistical analysis will be made with proportions for the
      categorical variables, and for numerical variables will be made with averages, medians,
      standard deviations and ranges. The comparison between categorical variables will be made
      with square Ji proof or exact Fisher's proof when square Ji proof doesn't meet the criteria.
      The comparison among continuous variables with normal distribution will be established with T
      student distribution proof or ANOVA, and Mann-Whitnew or Kruskall proofs will be used for
      variables that doesn't have this type of distribution.

      For the three survival rate, the Kaplan Meier method will be applied, and the survival curves
      will be compared with the logarithmic range proof. The Cox proportional hazard model is going
      to be used for the multivariate analysis and to stablish reasons. Additionally 5 interim
      analysis will be made.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Survival rate
time frame: 3 years
description: the disease free survival rate
measure: The response to treatment in terms of locoregional control of the disease
time frame: 3 years
description: efficacy
measure: Events adverse
time frame: 3 years
description: 4. Compare the appearance of severe and non severe adverse events directly related to the treatment in both intervention groups.
arm group label: Chemotherapy and concomitant radiotherapy
arm group type: Experimental
arm group label: Radiotherapy
arm group type: Active Comparator
intervention type: Radiation
intervention name: Chemotherapy and concomitant radiotherapy
description: Radiotherapy (teletherapy + high or low rate brachytherapy)
arm group label: Chemotherapy and concomitant radiotherapy
arm group label: Radiotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Uterine Cervical Neoplasms
sharing ipd: No