<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/NCT02257827</url>
  </required_header>
  <id_info>
    <org_study_id>FAMEMA-0913</org_study_id>
    <nct_id>NCT02257827</nct_id>
  </id_info>
  <brief_title>Trial Comparing Intensity Modulated Radiotherapy Versus Conformal Radiotherapy to Treat Prostate Cancer With Hypofractionated Schedule</brief_title>
  <official_title>Randomized Trial Comparing Intensity Modulated Radiotherapy Versus Conformal Radiotherapy to Treat Prostate Cancer With Hypofractionated Schedule.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gustavo Viani Arruda</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Marilia Medicine School</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is no randomized controlled trial (RCT) comparing Conformal Radiotherapy (3DCRT) versus&#xD;
      the Intensity Modulated Radiotherapy (IMRT) in terms of toxicity and disease control. Data&#xD;
      from retrospective studies show that IMRT reduces the risk of severe late complications. More&#xD;
      recently, the results from the RTOG 0126 study have also confirmed the benefit from IMRT in&#xD;
      reducing acute toxicity for prostate cancer treated with conventional dose escalation.&#xD;
      Therefore, to investigate the real clinical benefit of the IMRT over 3DCRT using a&#xD;
      hypofractionated schedule in prostate cancer, the investigators developed a RCT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2009</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gastrointestinal and geniturinary acute toxicity</measure>
    <time_frame>6 months</time_frame>
    <description>The primary study outcome was acute treatment reactions from the beginning of treatment to 6 months after the end of treatment. Patients were seen weekly, or as required, during treatment by a radiation oncologist. Acute gastrointestinal (GI) and genitourinary (GU) toxicity were prospectively assessed and graded according to the Radiation Therapy Oncology Group scoring system for the rectum and bladder.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gastrointestinal and geniturinary late toxicity</measure>
    <time_frame>24 months</time_frame>
    <description>Any toxicity developed after 6 months from radiotherapy treatment was considered as late toxicity. Late gastrointestinal (GI) and genitourinary (GU) toxicity were prospectively assessed and graded according to the Radiation Therapy Oncology Group scoring system for the rectum and bladder.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biochemical control</measure>
    <time_frame>3 years</time_frame>
    <description>The Phoenix criteria ( nadir + 2 ng/ml of PSA) was used to define the biochemical control.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">220</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>IMRT- Hypofractionated schedule 70 Gy/25 fx</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The IMRT plan consisted of five - seven fields to deliver the same dose prescribed at the isodose line covering 95% of PTV.By the linear-quadratic formula, considering an α/β ratio of 1.5 Gy for prostate cancer, 70 Gy/25 fractions is equivalent to 86 Gy in 43 fractions of 2 Gy. All patients were simulated on CT simulator.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3DCRT-Hypofractionated schedule 70 Gy/25 fx</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The 3DCRT plan consisted of six fields to deliver a total dose of 70 Gy/ 25 fractions of a single daily dose of 2.8 Gy. By the linear-quadratic formula, considering an α/β ratio of 1.5 Gy for prostate cancer, 70 Gy/25 fractions is equivalent to 86 Gy in 43 fractions of 2 Gy. All patients were simulated on CT simulator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>IMRT</intervention_name>
    <description>The IMRT plan consisted of five - seven fields to deliver the same dose prescribed at the isodose line covering 95% of PTV.&#xD;
The 3DCRT plan consisted of six fields to deliver a total dose of 70 Gy/ 25 fractions of a single daily dose of 2.8 Gy.</description>
    <arm_group_label>3DCRT-Hypofractionated schedule 70 Gy/25 fx</arm_group_label>
    <arm_group_label>IMRT- Hypofractionated schedule 70 Gy/25 fx</arm_group_label>
    <other_name>3DCRT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with diagnosis of prostate cancer&#xD;
&#xD;
          -  With age between 18-75 years classified in low&#xD;
&#xD;
          -  Intermediate and high-risk group according to their Gleason score&#xD;
&#xD;
          -  T stage and initial PSA (iPSA).&#xD;
&#xD;
          -  Low risk group included patients with Gleason score &lt;7 / stage T1-T2a, and iPSA &lt;10&#xD;
             ng/mL.&#xD;
&#xD;
          -  Intermediate risk included Gleason score &lt; 7, or Stage T1-T2b, or iPSA level of 10-20&#xD;
             ng/mL&#xD;
&#xD;
          -  High-risk patients with Gleason score &gt;7, or Stage &gt; T2b, or iPSA &gt;20 ng/mL.&#xD;
&#xD;
          -  All patients classified as high risk was submitted to the bone scans.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with metastases&#xD;
&#xD;
          -  Prior history of prostatectomy&#xD;
&#xD;
          -  Pelvic radiotherapy treatment&#xD;
&#xD;
          -  Chemotherapy treatment were excluded of this trial.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gustavo Viani, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>FAMEMA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine of Marilia</name>
      <address>
        <city>Marilia</city>
        <state>Sao Paulo</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>October 3, 2014</last_update_submitted>
  <last_update_submitted_qc>October 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Marilia Medicine School</investigator_affiliation>
    <investigator_full_name>Gustavo Viani Arruda</investigator_full_name>
    <investigator_title>Gustavo Arruda Viani, M.D, Phd.</investigator_title>
  </responsible_party>
  <keyword>Hypofractionated schedule</keyword>
  <keyword>Intensity Modulated Radiotherapy</keyword>
  <keyword>Conformal radiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_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/NCT02257827
org study id: FAMEMA-0913
nct id: NCT02257827
lead sponsor: 
has dmc: Yes
There is no randomized controlled trial (RCT) comparing Conformal Radiotherapy (3DCRT) versus
      the Intensity Modulated Radiotherapy (IMRT) in terms of toxicity and disease control. Data
      from retrospective studies show that IMRT reduces the risk of severe late complications. More
      recently, the results from the RTOG 0126 study have also confirmed the benefit from IMRT in
      reducing acute toxicity for prostate cancer treated with conventional dose escalation.
      Therefore, to investigate the real clinical benefit of the IMRT over 3DCRT using a
      hypofractionated schedule in prostate cancer, the investigators developed a RCT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Gastrointestinal and geniturinary acute toxicity
time frame: 6 months
description: The primary study outcome was acute treatment reactions from the beginning of treatment to 6 months after the end of treatment. Patients were seen weekly, or as required, during treatment by a radiation oncologist. Acute gastrointestinal (GI) and genitourinary (GU) toxicity were prospectively assessed and graded according to the Radiation Therapy Oncology Group scoring system for the rectum and bladder.
measure: Gastrointestinal and geniturinary late toxicity
time frame: 24 months
description: Any toxicity developed after 6 months from radiotherapy treatment was considered as late toxicity. Late gastrointestinal (GI) and genitourinary (GU) toxicity were prospectively assessed and graded according to the Radiation Therapy Oncology Group scoring system for the rectum and bladder.
measure: Biochemical control
time frame: 3 years
description: The Phoenix criteria ( nadir + 2 ng/ml of PSA) was used to define the biochemical control.
arm group label: IMRT- Hypofractionated schedule 70 Gy/25 fx
arm group type: Experimental
description: The IMRT plan consisted of five - seven fields to deliver the same dose prescribed at the isodose line covering 95% of PTV.By the linear-quadratic formula, considering an α/β ratio of 1.5 Gy for prostate cancer, 70 Gy/25 fractions is equivalent to 86 Gy in 43 fractions of 2 Gy. All patients were simulated on CT simulator.
arm group label: 3DCRT-Hypofractionated schedule 70 Gy/25 fx
arm group type: Active Comparator
description: The 3DCRT plan consisted of six fields to deliver a total dose of 70 Gy/ 25 fractions of a single daily dose of 2.8 Gy. By the linear-quadratic formula, considering an α/β ratio of 1.5 Gy for prostate cancer, 70 Gy/25 fractions is equivalent to 86 Gy in 43 fractions of 2 Gy. All patients were simulated on CT simulator.
intervention type: Radiation
intervention name: IMRT
description: The IMRT plan consisted of five - seven fields to deliver the same dose prescribed at the isodose line covering 95% of PTV.
The 3DCRT plan consisted of six fields to deliver a total dose of 70 Gy/ 25 fractions of a single daily dose of 2.8 Gy.
arm group label: 3DCRT-Hypofractionated schedule 70 Gy/25 fx
arm group label: IMRT- Hypofractionated schedule 70 Gy/25 fx
other name: 3DCRT
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Gustavo Viani, PhD
role: Principal Investigator
affiliation: FAMEMA
facility: 
country: Brazil
responsible party type: Sponsor-Investigator
investigator affiliation: Marilia Medicine School
investigator full name: Gustavo Viani Arruda
investigator title: Gustavo Arruda Viani, M.D, Phd.
mesh term: Prostatic Neoplasms