<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/NCT03268772</url>
  </required_header>
  <id_info>
    <org_study_id>CSPC-DMS-STS-01</org_study_id>
    <nct_id>NCT03268772</nct_id>
  </id_info>
  <brief_title>PLD and IFO As First-line Treatment for Patients With Advanced or Metastatic STS</brief_title>
  <official_title>Pegylated-liposome Doxorubicin Combined With Ifosfamide As First-line Treatment for Patients With Advanced or Metastatic Soft Tissue Sarcoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <has_dmc>No</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>
      This study is designed to evaluate the efficacy and safety of pegylated liposomal doxorubicin&#xD;
      (PLD) combined with ifosfamide (IFO) for the first-line treatment of patients with advanced&#xD;
      or metastatic soft tissue sarcoma (STS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This phase II study is designed to evaluate the efficacy and safety of pegylated liposomal&#xD;
      doxorubicin (PLD) combined with ifosfamide (IFO) for the first-line treatment of patients&#xD;
      with advanced or metastatic soft tissue sarcoma (STS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 1, 2015</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>progression free survival</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall response rate</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>biomarker analysis</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Soft Tissue Sarcoma</condition>
  <arm_group>
    <arm_group_label>PLD-IFO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>pegylated liposomal doxorubicin (PLD) combined with ifosfamide (IFO)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PLD and IFO</intervention_name>
    <description>PLD 30 mg/m2, d1, plus IFO 1.8 g/m2, d1-5</description>
    <arm_group_label>PLD-IFO</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 18-70 years with histologically confirmed advanced or metastatic STS&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status of 0 to 2&#xD;
&#xD;
          -  life expectancy of ≥ 3 months&#xD;
&#xD;
          -  have not received chemotherapy before&#xD;
&#xD;
          -  at least one measurable lesion&#xD;
&#xD;
          -  LVEF≥50%&#xD;
&#xD;
          -  have adequate bone marrow, hepatic, and renal function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  osteosarcoma, Ewing's sarcoma/PNET (primitive neurotodermal&#xD;
             tumour),GIST(Gastrointestinal Stromal Tumors), rhabdomyosarcoma, dermatofibrosarcoma&#xD;
             protuberans&#xD;
&#xD;
          -  patients with symptomatic brain metastases&#xD;
&#xD;
          -  active clinical severe infection&#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>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>April 21, 2020</last_update_submitted>
  <last_update_submitted_qc>April 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Zhiguo Luo, MD, PhD</investigator_full_name>
    <investigator_title>Vice professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03268772
org study id: CSPC-DMS-STS-01
nct id: NCT03268772
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is designed to evaluate the efficacy and safety of pegylated liposomal doxorubicin
      (PLD) combined with ifosfamide (IFO) for the first-line treatment of patients with advanced
      or metastatic soft tissue sarcoma (STS).
This phase II study is designed to evaluate the efficacy and safety of pegylated liposomal
      doxorubicin (PLD) combined with ifosfamide (IFO) for the first-line treatment of patients
      with advanced or metastatic soft tissue sarcoma (STS).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: progression free survival
time frame: 6 months
measure: overall response rate
time frame: 2 months
measure: overall survival
time frame: 12 months
measure: Adverse Events
time frame: 2 months
measure: biomarker analysis
time frame: 6 months
arm group label: PLD-IFO
arm group type: Experimental
description: pegylated liposomal doxorubicin (PLD) combined with ifosfamide (IFO)
intervention type: Drug
intervention name: PLD and IFO
description: PLD 30 mg/m2, d1, plus IFO 1.8 g/m2, d1-5
arm group label: PLD-IFO
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Zhiguo Luo, MD, PhD
investigator title: Vice professor
mesh term: Sarcoma
sharing ipd: No