<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/NCT01717729</url>
  </required_header>
  <id_info>
    <org_study_id>ABT-2000-235</org_study_id>
    <nct_id>NCT01717729</nct_id>
  </id_info>
  <brief_title>Hepatocellular Carcinoma Treated With Iodine-125 Implantation</brief_title>
  <official_title>Hepatocellular Carcinoma Treated With Radiofrequency Ablation With or Without Iodine-125 Implantation: A Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Second People's Hospital of GuangDong Province</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Second People's Hospital of GuangDong Province</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To prospectively evaluate whether use of combined radiofrequency ablation (RFA) and&#xD;
      percutaneous iodine-125 (125I) seeds implantation results in better survival compared with&#xD;
      use of RFA alone in patients with hepatocellular carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was local ethical committee approved; all patients gave written informed consent.&#xD;
      A total of 136 patients were randomly assigned to undergo RFA-125I (n = 68; 42 men, 26 women;&#xD;
      mean age, 50.7 years; age range, 29-73 years) or RFA alone (n = 68; 47 men, 21 women; mean&#xD;
      age, 48.9 years; age range, 30-74 years). Patients with viable tumors at computed tomography&#xD;
      (CT) 4 weeks after treatment received additional treatment. Rates of local tumor progression&#xD;
      and overall survival were evaluated by using Kaplan-Meier and log-rank tests, respectively.&#xD;
      The relative prognostic significance of variables in predicting overall survival and the time&#xD;
      to tumor recurrence or metastasis were assessed with multivariate Cox proportional hazards&#xD;
      regression and logistic regression analyses, respectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2000</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>recurrence rate</measure>
    <time_frame>up to 6 years</time_frame>
    <description>The primary endpoint was the time to recurrence(TTR) was measured from the date of treatment to the time when the recurrent tumor was first diagnosed. At spiral CT after treatment, residual viable tumor tissue was considered to be present if enhancing areas were seen within the tumor on either arterial phase or portal venous phase images. Depending on the initial random treatment assignment, RFA-125I or RFA alone was repeated. Magnetic resonance (MR) imaging was performed if there was uncertainty at CT as to whether residual viable tumor tissue was present.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>One-, 2-, 3-, 4-, and 5-year overall survival rates</measure>
    <time_frame>up to 6 years</time_frame>
    <description>urvival time was defined as the interval between the first treatment and either death or last follow-up visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Ablation</measure>
    <time_frame>up to 6 years</time_frame>
    <description>At spiral CT 4 weeks after treatment, residual viable tumor tissue was considered to be present if enhancing areas were seen within the tumor on either arterial phase or portal venous phase images.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">136</enrollment>
  <condition>Liver Carcinoma</condition>
  <arm_group>
    <arm_group_label>RFA-125I group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The combination RFA and 125I (RFA-125I) (n = 68; 42 men, 26 women; mean age, 50.7 years; age range, 29-73 years) In this group, patients were accepted not only radiofrequency ablation (RFA) but also iodine-125.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RFA-only group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>(n = 68; 47 men, 21 women; mean age, 48.9 years; age range, 30-74 years) In tis group,the patient were just peformed radiofrequency ablation alnoe.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radiofrequency Ablation</intervention_name>
    <description>For RFA, we used a commercially available system (RF 2000; Radio Therapeutics, Mountain View, Calif) and a needle electrode with a 15-gauge insulated cannula that had 10 hook-shaped expandable electrode tines with a diameter of 3.5 cm at expansion (LeVeen; Radio Therapeutics).The radioactivity per seed ranged from 0.5 to 0.6 millicuries (mCi)</description>
    <arm_group_label>RFA-125I group</arm_group_label>
    <arm_group_label>RFA-only group</arm_group_label>
    <other_name>Radio Therapeutics, Mountain View, Calif</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>iodine</intervention_name>
    <description>The 125I seeds (0.8 mm in diameter and 4.5mm in length) were enclosed in a NiTinol capsule (China Institute of Atomic Energy, Beijing). These seeds could produce 27.4-31.5 keV X-ray and 35.5 Kev γ ray, with a half-life of 59.6 days. The radioactivity per seed ranged from 0.5 to 0.6 millicuries (mCi).</description>
    <arm_group_label>RFA-125I group</arm_group_label>
    <other_name>iodine-125 seed</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (a) age 18-75 years and refusal to undergo surgery; (b) a solitary HCC 7.0 cm in diameter&#xD;
        or smaller or multiple (up to three) HCCs 3.0 cm in diameter or smaller; (c) lesions&#xD;
        visible at ultrasonography (US), with an acceptable and safe path between the lesion and&#xD;
        the skin seen on the US scan; (d) no extrahepatic metastasis; (e) no imaging evidence of&#xD;
        tumor invasion into the major portal or hepatic vein branches; (f) no history of&#xD;
        encephalopathy, ascites refractory to diuretics, or variceal bleeding; (g) a platelet count&#xD;
        of more than 40 000 cells/mm3 and (h) no previous treatment for HCC except liver resection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion criteria included active thyroid disease, serious concurrent medical illnesses,&#xD;
        extrahepatic diseases, previous anticancer treatment before surgery, histologically proved&#xD;
        non-HCC tumors and women who were pregnant or breastfeeding.&#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>kai yun chen, phD</last_name>
    <role>Study Chair</role>
    <affiliation>The second people's hospital</affiliation>
  </overall_official>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>October 26, 2012</last_update_submitted>
  <last_update_submitted_qc>October 26, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 30, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Second People's Hospital of GuangDong Province</investigator_affiliation>
    <investigator_full_name>KaiYun Chen</investigator_full_name>
    <investigator_title>SURGERY</investigator_title>
  </responsible_party>
  <keyword>HCC, RFA, Iodine-125, Recurrence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iodine</mesh_term>
  </intervention_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/NCT01717729
org study id: ABT-2000-235
nct id: NCT01717729
lead sponsor: 
has dmc: Yes
To prospectively evaluate whether use of combined radiofrequency ablation (RFA) and
      percutaneous iodine-125 (125I) seeds implantation results in better survival compared with
      use of RFA alone in patients with hepatocellular carcinoma.
This study was local ethical committee approved; all patients gave written informed consent.
      A total of 136 patients were randomly assigned to undergo RFA-125I (n = 68; 42 men, 26 women;
      mean age, 50.7 years; age range, 29-73 years) or RFA alone (n = 68; 47 men, 21 women; mean
      age, 48.9 years; age range, 30-74 years). Patients with viable tumors at computed tomography
      (CT) 4 weeks after treatment received additional treatment. Rates of local tumor progression
      and overall survival were evaluated by using Kaplan-Meier and log-rank tests, respectively.
      The relative prognostic significance of variables in predicting overall survival and the time
      to tumor recurrence or metastasis were assessed with multivariate Cox proportional hazards
      regression and logistic regression analyses, respectively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: recurrence rate
time frame: up to 6 years
description: The primary endpoint was the time to recurrence(TTR) was measured from the date of treatment to the time when the recurrent tumor was first diagnosed. At spiral CT after treatment, residual viable tumor tissue was considered to be present if enhancing areas were seen within the tumor on either arterial phase or portal venous phase images. Depending on the initial random treatment assignment, RFA-125I or RFA alone was repeated. Magnetic resonance (MR) imaging was performed if there was uncertainty at CT as to whether residual viable tumor tissue was present.
measure: One-, 2-, 3-, 4-, and 5-year overall survival rates
time frame: up to 6 years
description: urvival time was defined as the interval between the first treatment and either death or last follow-up visit.
measure: Complete Ablation
time frame: up to 6 years
description: At spiral CT 4 weeks after treatment, residual viable tumor tissue was considered to be present if enhancing areas were seen within the tumor on either arterial phase or portal venous phase images.
arm group label: RFA-125I group
arm group type: Experimental
description: The combination RFA and 125I (RFA-125I) (n = 68; 42 men, 26 women; mean age, 50.7 years; age range, 29-73 years) In this group, patients were accepted not only radiofrequency ablation (RFA) but also iodine-125.
arm group label: RFA-only group
arm group type: Active Comparator
description: (n = 68; 47 men, 21 women; mean age, 48.9 years; age range, 30-74 years) In tis group,the patient were just peformed radiofrequency ablation alnoe.
intervention type: Procedure
intervention name: Radiofrequency Ablation
description: For RFA, we used a commercially available system (RF 2000; Radio Therapeutics, Mountain View, Calif) and a needle electrode with a 15-gauge insulated cannula that had 10 hook-shaped expandable electrode tines with a diameter of 3.5 cm at expansion (LeVeen; Radio Therapeutics).The radioactivity per seed ranged from 0.5 to 0.6 millicuries (mCi)
arm group label: RFA-125I group
arm group label: RFA-only group
other name: Radio Therapeutics, Mountain View, Calif
intervention type: Radiation
intervention name: iodine
description: The 125I seeds (0.8 mm in diameter and 4.5mm in length) were enclosed in a NiTinol capsule (China Institute of Atomic Energy, Beijing). These seeds could produce 27.4-31.5 keV X-ray and 35.5 Kev γ ray, with a half-life of 59.6 days. The radioactivity per seed ranged from 0.5 to 0.6 millicuries (mCi).
arm group label: RFA-125I group
other name: iodine-125 seed
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: kai yun chen, phD
role: Study Chair
affiliation: The second people's hospital
responsible party type: Principal Investigator
investigator affiliation: The Second People's Hospital of GuangDong Province
investigator full name: KaiYun Chen
investigator title: SURGERY
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
mesh term: Iodine