<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/NCT03286348</url>
  </required_header>
  <id_info>
    <org_study_id>GINS-1001</org_study_id>
    <nct_id>NCT03286348</nct_id>
  </id_info>
  <brief_title>Analysis of Nutrition During Chemoradiotherapy in Patients With Gastrointestinal Cancer</brief_title>
  <official_title>Analysis of Nutrition During Chemoradiotherapy in Patients With Gastrointestinal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hubei Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fudan University</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>
      To assess the effectiveness of close and intense monitoring on nutritional status of&#xD;
      gastrointestinal cancer patients during chemoradiotherapy (CRT), 500 CRT patients diagnosed&#xD;
      with gastrointestinal system are going to be recruited into this prospective study.&#xD;
      Patient-generated subjective global assessment (PG-SGA) scale and nutrition risk screening&#xD;
      (NRS-2002) are used for nutritional assessment at the beginning and the end of CRT; Beside&#xD;
      the nutritional parameters, Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and gastric&#xD;
      cancer module (QLQ-STO22) are used to measure quality of life in patients with gastric cancer&#xD;
      while EORTC QLQ-C30 and Colorectal Cancer-Specific Quality of Life Questionnaire (QLQ-CR38)&#xD;
      give assessment in colorectal cancer. The acute and late radiation toxicities were evaluated&#xD;
      based on Conmon terminology criteria (CTC V3.0) and the toxicity criteria of RTOG/EORTC,&#xD;
      respectively. Follow-ups every 3-6 months until three years after chemoradiotherapy are&#xD;
      involved. Response Evaluation Criteria in Solid Tumors (RECIST) guidelines are used for&#xD;
      response assessment. The primary endpoints are 3-year local control, disease-free survival,&#xD;
      distant metastasis and overall survival rate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">October 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Local Control rate</measure>
    <time_frame>From date of randomization until the date of first documented pelvic failure, assessed up to 3 years</time_frame>
    <description>Number of participants with abdominal or pelvic failure after surgery, evaluated using Kaplan-Meier Curve</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease-free Survival</measure>
    <time_frame>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>From date of randomization until the date of death from any cause, assessed up to 3 years</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Nutritional Status</condition>
  <condition>Gastrointestinal Cancer</condition>
  <condition>Chemoradiotherapy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        gastric cancer patients and rectal cancer patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for Gastric Cancer:&#xD;
&#xD;
          -  pathological confirmed adenocarcinoma&#xD;
&#xD;
          -  clinical stage T3-4 and/or N+ after radical surgery&#xD;
&#xD;
          -  without distance metastases&#xD;
&#xD;
          -  KPS &gt;=70&#xD;
&#xD;
          -  without previous radiotherapy&#xD;
&#xD;
          -  sign the inform consent&#xD;
&#xD;
        Inclusion Criteria for Rectal Cancer:&#xD;
&#xD;
          -  pathological confirmed adenocarcinoma&#xD;
&#xD;
          -  clinical stage T3-4 and/or N+&#xD;
&#xD;
          -  the distance from anal verge less than 12 cm&#xD;
&#xD;
          -  without distance metastases&#xD;
&#xD;
          -  KPS &gt;=70&#xD;
&#xD;
          -  without previous anti-cancer therapy&#xD;
&#xD;
          -  sign the inform consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy or breast-feeding women&#xD;
&#xD;
          -  serious medical illness&#xD;
&#xD;
          -  baseline blood and biochemical indicators do not meet the following criteria:&#xD;
             neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN&#xD;
&#xD;
          -  DPD deficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Zhen Zhang</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wenjie Sun, MD</last_name>
      <phone>862164175590</phone>
      <phone_ext>1606</phone_ext>
      <email>617057654@qq.com</email>
    </contact>
    <investigator>
      <last_name>Zhen Zhang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>September 15, 2017</last_update_submitted>
  <last_update_submitted_qc>September 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Zhen Zhang</investigator_full_name>
    <investigator_title>MD, PHD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal 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/NCT03286348
org study id: GINS-1001
nct id: NCT03286348
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To assess the effectiveness of close and intense monitoring on nutritional status of
      gastrointestinal cancer patients during chemoradiotherapy (CRT), 500 CRT patients diagnosed
      with gastrointestinal system are going to be recruited into this prospective study.
      Patient-generated subjective global assessment (PG-SGA) scale and nutrition risk screening
      (NRS-2002) are used for nutritional assessment at the beginning and the end of CRT; Beside
      the nutritional parameters, Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and gastric
      cancer module (QLQ-STO22) are used to measure quality of life in patients with gastric cancer
      while EORTC QLQ-C30 and Colorectal Cancer-Specific Quality of Life Questionnaire (QLQ-CR38)
      give assessment in colorectal cancer. The acute and late radiation toxicities were evaluated
      based on Conmon terminology criteria (CTC V3.0) and the toxicity criteria of RTOG/EORTC,
      respectively. Follow-ups every 3-6 months until three years after chemoradiotherapy are
      involved. Response Evaluation Criteria in Solid Tumors (RECIST) guidelines are used for
      response assessment. The primary endpoints are 3-year local control, disease-free survival,
      distant metastasis and overall survival rate.
observational model: Ecologic or Community
time perspective: Prospective
measure: Local Control rate
time frame: From date of randomization until the date of first documented pelvic failure, assessed up to 3 years
description: Number of participants with abdominal or pelvic failure after surgery, evaluated using Kaplan-Meier Curve
measure: Disease-free Survival
time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
measure: Overall Survival
time frame: From date of randomization until the date of death from any cause, assessed up to 3 years
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Zhen Zhang
investigator title: MD, PHD
mesh term: Gastrointestinal Neoplasms