<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/NCT03292991</url>
  </required_header>
  <id_info>
    <org_study_id>QCR14021</org_study_id>
    <nct_id>NCT03292991</nct_id>
  </id_info>
  <brief_title>REgistry of Selective Internal Radiation Therapy in TaiwaN (RESIN)</brief_title>
  <official_title>REgistry of Selective Internal Radiation Therapy in TaiwaN (RESIN)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Veterans General Hospital, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kaohsiung Veterans General Hospital.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>China Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mackay Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Taipei Veterans General Hospital, Taiwan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      All study objectives will be assessed in HCC patients or colorectal cancer patients with&#xD;
      secondary metastases in the liver, respectively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All study objectives will be assessed in HCC patients or colorectal cancer patients with&#xD;
      secondary metastases in the liver, respectively.&#xD;
&#xD;
        1. Primary objective:&#xD;
&#xD;
             -  To observe the safety of SIR-Spheres® microspheres therapy (SIRT)by,&#xD;
&#xD;
                  -  Adverse events and serious adverse events (non-specific and radiation&#xD;
                     specific)&#xD;
&#xD;
                  -  Changes in liver function parameters&#xD;
&#xD;
             -  To observe the efficacy of SIR-Spheres® microspheres therapy by, assessing the best&#xD;
                overall response rate after SIRT&#xD;
&#xD;
        2. Secondary objectives:&#xD;
&#xD;
             -  To observe the efficacy of SIRT by,&#xD;
&#xD;
                  -  Overall survival (OS)&#xD;
&#xD;
                  -  Overall/objective response rate (ORR)&#xD;
&#xD;
                  -  Time-to-progression&#xD;
&#xD;
                  -  Time-to-liver progression&#xD;
&#xD;
                  -  Progression-free survival&#xD;
&#xD;
             -  To observe the changes in clinical presentation after SIRT by,&#xD;
&#xD;
                  -  ECOG score&#xD;
&#xD;
                  -  Child-Pugh score&#xD;
&#xD;
                  -  Percentage of subjects with down-staging or down-sizing of treated lesion to&#xD;
                     resection, transplantation, or radiofrequency ablation (RFA)&#xD;
&#xD;
             -  To observe the practice pattern of SIRT by,&#xD;
&#xD;
                  -  Median dosage (GBq)&#xD;
&#xD;
                  -  Number of SIRT sessions received by subjects&#xD;
&#xD;
        3. Exploratory objectives:&#xD;
&#xD;
             -  To explore prognostic factors for disease progression after SIRT by comparing the&#xD;
                following parameters:&#xD;
&#xD;
                  -  Number of tumors in subjects prior to SIRT&#xD;
&#xD;
                  -  Median tumor size in subjects prior to SIRT&#xD;
&#xD;
                  -  Location of tumor in subjects treated with SIRT (hepatic segment or lobe)&#xD;
&#xD;
                  -  Number of prior TACE treatment in subjects&#xD;
&#xD;
                  -  Antiviral therapy subjects HCC&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 9, 2015</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Safety as per CTCAE 4.03, incidence of AEs and baseline change in liver function paired t-test or Wilcoxon signed rank test.</measure>
    <time_frame>6 months</time_frame>
    <description>Toxicity will be accessed according to CTCAE v4.03. The incidence of adverse events will be summarized and the change in baseline liver function will be assessed by paired t-test or Wilcoxon signed rank test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>1 year</time_frame>
    <description>Overall survival (OS) is determined for all enrolled subjects from Day 0 to the date of death or last contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate per RECIST 1.1 and mRECIST</measure>
    <time_frame>1 year</time_frame>
    <description>Liver tumor assessments for CRC will be evaluated by RECIST v1.1; and tumor assessments for HCC will be evaluated by mRECIST.&#xD;
- Objective Response Rate is defined as the proportion of subjects with tumor size reduction (i.e. the combined proportion of subjects with CR and PR) from Day 0 until documented tumor progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time-to-progression per RECIST 1.1 and mRECIST</measure>
    <time_frame>1 year</time_frame>
    <description>The time-to-progression (TTP) is calculated by the time from Day 0 to the date of disease progression (PD).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time-to-liver progression per RECIST 1.1 and mRECIST</measure>
    <time_frame>1 year</time_frame>
    <description>The time-to-liver progression is calculated by the time from Day 0 to the date of tumor progression (PD) in intrahepatic lesions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>1 year</time_frame>
    <description>Progression free survival (PFS) is determined for all enrolled patients from Day 0 until tumor progression or patient death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver resection rate</measure>
    <time_frame>1 year</time_frame>
    <description>Patients will be assessed for suitability for liver resection every study visit during the study period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver transplantation rate</measure>
    <time_frame>1 year</time_frame>
    <description>Patients will be assessed for suitability for liver transplantation every study visit during the study period.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        HCC patients or colorectal cancer patients with secondary metastases in the liver.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria, Patients who meet all inclusion criteria will be included:&#xD;
&#xD;
          -  Males or non-pregnant females, at least 18 years of age (inclusive).&#xD;
&#xD;
          -  Patients with clinically confirmed hepatocellular carcinoma (HCC) OR adenocarcinoma of&#xD;
             colon/rectum with liver metastasis.&#xD;
&#xD;
          -  Patients with liver dominant disease.&#xD;
&#xD;
          -  Tumor burden ≤ 70% of total liver volume.&#xD;
&#xD;
          -  HCC patients with child-Pugh Score class A or B.&#xD;
&#xD;
          -  HCC patients with Barcelona-Clinic Liver Cancer (BCLC) stage A-C.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.&#xD;
&#xD;
          -  Patients who are unsuitable for resection or immediate liver transplantation or who&#xD;
             cannot be optimally treated with local ablation.&#xD;
&#xD;
          -  Patients who have provided written informed consent.&#xD;
&#xD;
        Exclusion Criteria, Patients who meet any exclusion criteria will be excluded:&#xD;
&#xD;
          -  Patients known to be hypersensitive to any component of study product.&#xD;
&#xD;
          -  Female patients who are pregnant or lactating. Women of child bearing potential who&#xD;
             disagree to practice medically recognized birth control methods throughout the study&#xD;
             (from Screening to approximately 6 months post SIRT). Medically recognized birth&#xD;
             control methods include hormonal contraceptives, intrauterine device/IUD, barrier&#xD;
             device, or abstinence. With the exception of women who had been surgically sterilized&#xD;
             (defined as having undergone hysterectomy or bilateral oophorectomy or bilateral&#xD;
             salpingectomy; tubal ligation alone is not considered sufficient), or one year&#xD;
             post-menopausal.&#xD;
&#xD;
        Withdrawal criteria:&#xD;
&#xD;
          -  Patients consent withdrawal.&#xD;
&#xD;
          -  Lost to follow-up for 2 consecutive visits.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rheun-Chuan Lee, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Veterans General Hospital, Taiwan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rheun-Chuan Lee, M.D.</last_name>
    <phone>+886-2-28712121</phone>
    <phone_ext>3069</phone_ext>
    <email>vghtpeyttrium90@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rheun-Chuan Lee, M.D.</last_name>
      <phone>+886-2-28712121</phone>
      <phone_ext>3069</phone_ext>
      <email>vghtpeyttrium90@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>September 20, 2017</last_update_submitted>
  <last_update_submitted_qc>September 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Veterans General Hospital, Taiwan</investigator_affiliation>
    <investigator_full_name>vghtpe user</investigator_full_name>
    <investigator_title>Principal Investigator, Dr. Rheun-Chuan Lee</investigator_title>
  </responsible_party>
  <keyword>Hepatocellular Carcinoma</keyword>
  <keyword>SIR Spheres</keyword>
  <keyword>SIRT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Hepatocellular</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/NCT03292991
org study id: QCR14021
nct id: NCT03292991
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
All study objectives will be assessed in HCC patients or colorectal cancer patients with
      secondary metastases in the liver, respectively.
All study objectives will be assessed in HCC patients or colorectal cancer patients with
      secondary metastases in the liver, respectively.

        1. Primary objective:

             -  To observe the safety of SIR-Spheres® microspheres therapy (SIRT)by,

                  -  Adverse events and serious adverse events (non-specific and radiation
                     specific)

                  -  Changes in liver function parameters

             -  To observe the efficacy of SIR-Spheres® microspheres therapy by, assessing the best
                overall response rate after SIRT

        2. Secondary objectives:

             -  To observe the efficacy of SIRT by,

                  -  Overall survival (OS)

                  -  Overall/objective response rate (ORR)

                  -  Time-to-progression

                  -  Time-to-liver progression

                  -  Progression-free survival

             -  To observe the changes in clinical presentation after SIRT by,

                  -  ECOG score

                  -  Child-Pugh score

                  -  Percentage of subjects with down-staging or down-sizing of treated lesion to
                     resection, transplantation, or radiofrequency ablation (RFA)

             -  To observe the practice pattern of SIRT by,

                  -  Median dosage (GBq)

                  -  Number of SIRT sessions received by subjects

        3. Exploratory objectives:

             -  To explore prognostic factors for disease progression after SIRT by comparing the
                following parameters:

                  -  Number of tumors in subjects prior to SIRT

                  -  Median tumor size in subjects prior to SIRT

                  -  Location of tumor in subjects treated with SIRT (hepatic segment or lobe)

                  -  Number of prior TACE treatment in subjects

                  -  Antiviral therapy subjects HCC
observational model: Case-Only
time perspective: Prospective
measure: Safety as per CTCAE 4.03, incidence of AEs and baseline change in liver function paired t-test or Wilcoxon signed rank test.
time frame: 6 months
description: Toxicity will be accessed according to CTCAE v4.03. The incidence of adverse events will be summarized and the change in baseline liver function will be assessed by paired t-test or Wilcoxon signed rank test.
measure: Overall survival
time frame: 1 year
description: Overall survival (OS) is determined for all enrolled subjects from Day 0 to the date of death or last contact.
measure: Overall Response Rate per RECIST 1.1 and mRECIST
time frame: 1 year
description: Liver tumor assessments for CRC will be evaluated by RECIST v1.1; and tumor assessments for HCC will be evaluated by mRECIST.
- Objective Response Rate is defined as the proportion of subjects with tumor size reduction (i.e. the combined proportion of subjects with CR and PR) from Day 0 until documented tumor progression.
measure: Time-to-progression per RECIST 1.1 and mRECIST
time frame: 1 year
description: The time-to-progression (TTP) is calculated by the time from Day 0 to the date of disease progression (PD).
measure: Time-to-liver progression per RECIST 1.1 and mRECIST
time frame: 1 year
description: The time-to-liver progression is calculated by the time from Day 0 to the date of tumor progression (PD) in intrahepatic lesions.
measure: Progression-free survival
time frame: 1 year
description: Progression free survival (PFS) is determined for all enrolled patients from Day 0 until tumor progression or patient death.
measure: Liver resection rate
time frame: 1 year
description: Patients will be assessed for suitability for liver resection every study visit during the study period.
measure: Liver transplantation rate
time frame: 1 year
description: Patients will be assessed for suitability for liver transplantation every study visit during the study period.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Rheun-Chuan Lee, M.D.
role: Principal Investigator
affiliation: Taipei Veterans General Hospital, Taiwan
last name: Rheun-Chuan Lee, M.D.
phone: +886-2-28712121
phone ext: 3069
email: vghtpeyttrium90@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Taipei Veterans General Hospital, Taiwan
investigator full name: vghtpe user
investigator title: Principal Investigator, Dr. Rheun-Chuan Lee
mesh term: Carcinoma, Hepatocellular