<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/NCT02195141</url>
  </required_header>
  <id_info>
    <org_study_id>NCC2014-ST02</org_study_id>
    <nct_id>NCT02195141</nct_id>
  </id_info>
  <brief_title>Trial of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer</brief_title>
  <official_title>Randomized Phase II Tiral of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pathological complete response, (pCR) correlates with a favorable overall prognosis in&#xD;
      locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a&#xD;
      pCR might be beneficial. The aim of the study is to investigate safety and efficacy of&#xD;
      preoperative SIB-IMRT(56Gy) combine with capecitabine. primary endpoint is pathological&#xD;
      complete remission rate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>Phase 2</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>• Pathological complete remission rate (pCR)</measure>
    <time_frame>after pathological examination of surgical speciments (6-8 weeks after chemoradiation)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events (according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)</measure>
    <time_frame>during preoperative treatment and after surgery for 5 years</time_frame>
    <description>Acute toxicities will be assessed every week during chemoradiation period , one week before surgery(6 weeks after chemoradiation) and every 3 months after surgery for 2 years.Late toxicities will be assessed every 6 months from the 3rd year for 3 years.Adverse eventswill be evaluated according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>• Disease-free survival</measure>
    <time_frame>3 year afte concurrent chemoradiation</time_frame>
    <description>Followup will be done every 3 months in first 2 years, and every 6 months after 2 years.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">104</enrollment>
  <condition>Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>conventional fraction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Radiotherapy (25x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SIB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Concomitant chemoradiotherapy Radiotherapy with boost Radiotherapy (25 x 2 Gy), with a simultaneous integrated boost up to 56 Gy on the primary tumor capecitabine 825mg/m2 p.o. twice daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>conventional fraction</intervention_name>
    <description>capecitabine 825mg/m2 p.o. twice daily Radiotherapy 50Gy/25f</description>
    <arm_group_label>conventional fraction</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>SIB</intervention_name>
    <description>Concomitant chemoradiotherapy Radiotherapy with boost Radiotherapy (25 x 2 Gy), with a simultaneous integrated boost up to 56 Gy on the primary tumor capecitabine 825mg/m2 p.o. twice daily</description>
    <arm_group_label>SIB</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  histopathologically confirmed rectal adenocarcinoma with an inferior border within 15&#xD;
             cm of the anal verge&#xD;
&#xD;
          -  the tumor has to have evidence of T3 or T4 disease on Magnetic Resonance Imaging (MRI)&#xD;
             or endoluminal ultrasound&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  metastatic disease&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status &gt; 3&#xD;
&#xD;
          -  patients not deemed fit for radiotherapy, capecitabine or surgery&#xD;
&#xD;
          -  pregnant or lactating patients&#xD;
&#xD;
          -  women with child bearing potential who lack effective contraception&#xD;
&#xD;
          -  patients below 18 years old&#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>Jing Jin, proffessor</last_name>
    <role>Study Chair</role>
    <affiliation>Dept of Radiation oncology, Cancer hospital, CAMS</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jing Jin, Professor</last_name>
    <phone>87788280</phone>
    <email>jingjin1025@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hua Ren, Attending</last_name>
    <phone>87788122</phone>
    <email>renhua2009@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cancer Hospital, CAMS</name>
      <address>
        <city>Beijing</city>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jing Jin, professor</last_name>
      <phone>87788200</phone>
      <email>jingjin1025@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Hua Ren, attending</last_name>
      <phone>87788122</phone>
      <email>renhua2009@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>February 2, 2015</last_update_submitted>
  <last_update_submitted_qc>February 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Hua Ren</investigator_full_name>
    <investigator_title>Attending physician</investigator_title>
  </responsible_party>
  <keyword>Preoperative Chemoradiotherapy</keyword>
  <keyword>Locally Advanced Rectal Cancer</keyword>
  <keyword>boost</keyword>
  <keyword>IMRT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal 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/NCT02195141
org study id: NCC2014-ST02
nct id: NCT02195141
lead sponsor: 
has dmc: No
Pathological complete response, (pCR) correlates with a favorable overall prognosis in
      locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a
      pCR might be beneficial. The aim of the study is to investigate safety and efficacy of
      preoperative SIB-IMRT(56Gy) combine with capecitabine. primary endpoint is pathological
      complete remission rate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: • Pathological complete remission rate (pCR)
time frame: after pathological examination of surgical speciments (6-8 weeks after chemoradiation)
measure: Number of participants with adverse events (according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
time frame: during preoperative treatment and after surgery for 5 years
description: Acute toxicities will be assessed every week during chemoradiation period , one week before surgery(6 weeks after chemoradiation) and every 3 months after surgery for 2 years.Late toxicities will be assessed every 6 months from the 3rd year for 3 years.Adverse eventswill be evaluated according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
measure: • Disease-free survival
time frame: 3 year afte concurrent chemoradiation
description: Followup will be done every 3 months in first 2 years, and every 6 months after 2 years.
arm group label: conventional fraction
arm group type: Active Comparator
description: Radiotherapy (25x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily
arm group label: SIB
arm group type: Experimental
description: Concomitant chemoradiotherapy Radiotherapy with boost Radiotherapy (25 x 2 Gy), with a simultaneous integrated boost up to 56 Gy on the primary tumor capecitabine 825mg/m2 p.o. twice daily
intervention type: Radiation
intervention name: conventional fraction
description: capecitabine 825mg/m2 p.o. twice daily Radiotherapy 50Gy/25f
arm group label: conventional fraction
intervention type: Radiation
intervention name: SIB
description: Concomitant chemoradiotherapy Radiotherapy with boost Radiotherapy (25 x 2 Gy), with a simultaneous integrated boost up to 56 Gy on the primary tumor capecitabine 825mg/m2 p.o. twice daily
arm group label: SIB
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jing Jin, proffessor
role: Study Chair
affiliation: Dept of Radiation oncology, Cancer hospital, CAMS
last name: Jing Jin, Professor
phone: 87788280
email: jingjin1025@163.com
last name: Hua Ren, Attending
phone: 87788122
email: renhua2009@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Hua Ren
investigator title: Attending physician
mesh term: Rectal Neoplasms