<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/NCT01709253</url>
  </required_header>
  <id_info>
    <org_study_id>NCCCTS 07-253</org_study_id>
    <nct_id>NCT01709253</nct_id>
  </id_info>
  <brief_title>Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma</brief_title>
  <official_title>Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Center, Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cancer Center, Korea</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2007</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>clinical outcomes</measure>
    <time_frame>up to 5years from a initial follow-up</time_frame>
    <description>To evaluate biochemical failure-free survival (BCFFS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>acute toxicity</measure>
    <time_frame>up to 5years from a initial follow-up</time_frame>
    <description>to evaluate acute toxicities by CTCAE version 3.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>late toxicity</measure>
    <time_frame>up to 5years from a initial follow-up</time_frame>
    <description>to evaluated late toxicities by CTCAE version 3.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>up to 5years from a initial follow-up</time_frame>
    <description>to evaluated overall survival</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">117</enrollment>
  <condition>Prostate Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>27pt/60CGE/20fx/5wks to PGTV(mon, tue, thu, fri; 4/wk)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>27pt/54CGE/15fx/5wks to PGTV (mon, wed, fri; 3/wk)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>27pt / 47CGE/10fx/5wk to PGTV(tue, thu;2/wk)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>27pt/ 35CGE/ 5fx/2.5wk to PGTV(the, thu; 2/wk)</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>proton beam therapy</intervention_name>
    <description>hypofractionation study using proton beam therapy for prostate adenocarcinoma</description>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_label>Arm 3</arm_group_label>
    <arm_group_label>Arm 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Biopsy proven prostate adenocarcinoma Stage: T1-T2cN0M0 ECOG performance status: 0-2 Signed&#xD;
        study specific informed consent prior to study entry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Postoperative residual or recurrent tumor Evidence of distant metastases Previous&#xD;
        irradiation for the tumor in the same location Adjuvant anti-androgenic hormonal therapy&#xD;
        High risk group (NCCN guide line)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>kwan ho cho, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Center, Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National cancer center, korea</name>
      <address>
        <city>Goyang-si</city>
        <state>Gyeonggi-do,</state>
        <zip>411-769</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>March 27, 2017</last_update_submitted>
  <last_update_submitted_qc>March 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cancer Center, Korea</investigator_affiliation>
    <investigator_full_name>Kwan Ho Cho</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>hpofractionation study using proton beam therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <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/NCT01709253
org study id: NCCCTS 07-253
nct id: NCT01709253
lead sponsor: 
has dmc: No
Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: clinical outcomes
time frame: up to 5years from a initial follow-up
description: To evaluate biochemical failure-free survival (BCFFS)
measure: acute toxicity
time frame: up to 5years from a initial follow-up
description: to evaluate acute toxicities by CTCAE version 3.0
measure: late toxicity
time frame: up to 5years from a initial follow-up
description: to evaluated late toxicities by CTCAE version 3.0
measure: overall survival
time frame: up to 5years from a initial follow-up
description: to evaluated overall survival
arm group label: Arm 1
arm group type: Experimental
description: 27pt/60CGE/20fx/5wks to PGTV(mon, tue, thu, fri; 4/wk)
arm group label: Arm 2
arm group type: Experimental
description: 27pt/54CGE/15fx/5wks to PGTV (mon, wed, fri; 3/wk)
arm group label: Arm 3
arm group type: Experimental
description: 27pt / 47CGE/10fx/5wk to PGTV(tue, thu;2/wk)
arm group label: Arm 4
arm group type: Experimental
description: 27pt/ 35CGE/ 5fx/2.5wk to PGTV(the, thu; 2/wk)
intervention type: Radiation
intervention name: proton beam therapy
description: hypofractionation study using proton beam therapy for prostate adenocarcinoma
arm group label: Arm 1
arm group label: Arm 2
arm group label: Arm 3
arm group label: Arm 4
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: kwan ho cho, M.D.
role: Principal Investigator
affiliation: National Cancer Center, Korea
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: National Cancer Center, Korea
investigator full name: Kwan Ho Cho
investigator title: M.D.
mesh term: Adenocarcinoma
mesh term: Prostatic Neoplasms