<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/NCT03794778</url>
  </required_header>
  <id_info>
    <org_study_id>20180148</org_study_id>
    <nct_id>NCT03794778</nct_id>
  </id_info>
  <brief_title>Evaluation of PLD Combined With Carboplatin Versus Paclitaxel Plus Carboplatin in the First-line Treatment of Epithelial Ovarian Cancer</brief_title>
  <official_title>Evaluation of PEGylated Doxorubicin Hydrochloride Liposome Injection(Duomeisu®) Combined With Carboplatin Versus Paclitaxel Plus Carboplatin in the First-line Treatment of Epithelial Ovarian Cancer: A Randomized, Open, Multicenter Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Women's Hospital School Of Medicine Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Women's Hospital School Of Medicine Zhejiang 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>
      This is a randomized, multicenter, open, controlled Post-Marketing Study. 396 patients who&#xD;
      were histopathology or exfoliated cell pathology of pleural and ascites confirmed with&#xD;
      epithelial ovarian cancer/fallopian tube/peritoneal cancer were enrolled in this study. The&#xD;
      subjects will be randomly assigned to one of the two treatment groups at a 1: 1 ratio, and&#xD;
      the stratification factors included: chemotherapy type (adjuvant chemotherapy/neoadjuvant&#xD;
      chemotherapy), residual disease after surgery (&gt;1cm, &lt;1cm, no primary surgery), stage (Ic,&#xD;
      II, III or IV), pathological typing, Eastern Cooperative Oncology Group performance status (0&#xD;
      to 1 or 2), BRCA1/2 gene mutation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will receive one of two treatment regimens:&#xD;
&#xD;
      Group A: intravenous infusion of liposomal doxorubicin 30 mg/m2, d1; carboplatin AUC 5 (dosed&#xD;
      according to the Calvert formula, with creatinine clearance estimated according to the&#xD;
      Cockcroftformula), intravenous infusion, d1; once every 21days, 3~6 cycles for early stage&#xD;
      patients and 6 cycles for late stage.&#xD;
&#xD;
      Group B: intravenous infusion of paclitaxel 175 mg/m2, d1; carboplatin AUC 5, intravenous&#xD;
      infusion, d1; once every 21days, 3~6 cycles for early stage patients and 6 cycles for late&#xD;
      stage. Treatment was initially administered for three cycles, and patients with stable or&#xD;
      responding disease continued treatment for further a three cycles.&#xD;
&#xD;
      The main purpose is to evaluate the efficacy and safety of liposomal doxorubicin plus&#xD;
      carboplatin in the first-line treatment of epithelial ovarian cancer. The primary endpoint is&#xD;
      progression free survival (PFS), the secondary endpoints include overall survival (OS),&#xD;
      objective response rate (ORR), disease control rate (DCR):CR+PR+SD, the incidence and&#xD;
      severity of adverse reactions and health-related quality of life (HQL) assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 19, 2019</start_date>
  <completion_date type="Anticipated">March 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2024</primary_completion_date>
  <phase>Phase 4</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>PFS</measure>
    <time_frame>From date of randomization until the date of first documented progression or death from any cause, whichever occurred first, or last follow-up for patients alive without progression, assessed up to approximately 36 months.</time_frame>
    <description>PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>OS</measure>
    <time_frame>From date of randomization until the date of death from any cause, or date of last follow-up for patients still alive, assessed up to 36 months</time_frame>
    <description>overall survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ORR</measure>
    <time_frame>From date of randomization until PD or death from any cause, assessed up to 36 months.</time_frame>
    <description>ORR is defined as the rate of CR or PR, as determined by IRC using RECIST v1.1 criteria among patients with at least one target lesion. Activity was also described in women with nontarget lesions only and in women without any tumor lesion but with elevated CA-125 levels before starting treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DCR</measure>
    <time_frame>From date of randomization until PD or death from any cause, assessed up to 36 months.</time_frame>
    <description>DCR is defined as the rate of of CR, PR, or stable disease according to RECIST v1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the incidence and severity of adverse reactions</measure>
    <time_frame>A summary of adverse events of each cycle,from date of administration of drugs until 30 days after the last chemotherapy or progression,whichever came first,assessed up to 36 months.</time_frame>
    <description>Evaluate the adverse reactions rate of drugs assessed by number and severity of adverse events in the treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life assessment</measure>
    <time_frame>It will be assessed at baseline and before the administration of drugs at each first day of every two chemotherapy cycles, up to 6 cycles,each cycle is 21 days.</time_frame>
    <description>according to the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30).The basic content of life quality assessment includes: physical health, mental health, social function, disease status and overall health perception.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">396</enrollment>
  <condition>Efficacy and Safety</condition>
  <arm_group>
    <arm_group_label>study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>pegylated liposomal doxorubicin 30 mg/m2, i.v.,d1; carboplatin AUC 5,i.v.,d1; once every 21days, 3~6 cycles for early stage patients and 6 cycles for late stage.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>chemotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>paclitaxel 175 mg/m2, i.v.,d1; carboplatin AUC 5, i.v.,d1; once every 21days, 3~6 cycles for early stage patients and 6 cycles for late stage.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>pegylated liposomal doxorubicin</intervention_name>
    <description>PLD 30 mg/m2, i.v.,d1; once every 21days</description>
    <arm_group_label>study group</arm_group_label>
    <other_name>duomeisu</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>paclitaxel</intervention_name>
    <description>paclitaxel 175 mg/m2, i.v.,d1; once every 21days</description>
    <arm_group_label>chemotherapy</arm_group_label>
    <other_name>zishanchun</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>carboplatin AUC 5, i.v.,d1; once every 21days,</description>
    <arm_group_label>chemotherapy</arm_group_label>
    <arm_group_label>study group</arm_group_label>
    <other_name>kabo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-75years old;&#xD;
&#xD;
          -  Histopathologically or exfoliated cell pathology of pleural and ascites confirmed with&#xD;
             epithelial ovarian cancer/fallopian tube/peritoneal cancer;&#xD;
&#xD;
          -  According to the International Federation of Obstetrics and Gynecology (FIGO), the&#xD;
             stage is Ic-IV;&#xD;
&#xD;
          -  Imaging assessment is based on the solid tumor efficacy evaluation standard (RECIST)&#xD;
             version 1.1, lesions can be measured, or patients' CA125 assessed according to GCIG&#xD;
             criteria;&#xD;
&#xD;
          -  Neoadjuvant chemotherapy can be given to patients with excessive tumor volume or a&#xD;
             wide range of lesions, who are not expected to achieve ideal cytoreductions before&#xD;
             surgery;&#xD;
&#xD;
          -  ECOG score ≤ 2;&#xD;
&#xD;
          -  Expected survival time ≥ 3 months;&#xD;
&#xD;
          -  LVEF ≥ 50%;&#xD;
&#xD;
          -  Bone Marrow Function: ANC：≥1.5×109/L； PLT：≥100×109/L；Hb: ≥90g/L;&#xD;
&#xD;
          -  Liver and renal function:Serum creatinine ≤ normal upper limit (ULN) 1.5times;&#xD;
             aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ULN 2.5times, or&#xD;
             &lt;ULN 5times in the presence of liver metastasis; total bilirubin (TBil) level≤ ULN 1.5&#xD;
             times, or ≤ ULN 2.5times if Gilbert's syndrome are present;&#xD;
&#xD;
          -  The childbearing age subjects must agree to take effective contraceptive measures&#xD;
             during the trial; the serum or urine pregnancy test must be negative, non-lactating;&#xD;
&#xD;
          -  Signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with low-grade malignant potential ovarian tumors;&#xD;
&#xD;
          -  Patients who had previously received chemotherapy or pelvic and abdominal&#xD;
             radiotherapy;&#xD;
&#xD;
          -  Patients planning to receive abdominal or pelvic chemotherapy;&#xD;
&#xD;
          -  The New York Heart Association (NYHA) graded class II heart disease patients&#xD;
             (including grade II) previous or current;&#xD;
&#xD;
          -  Other malignant tumors have been found in the past 5 years,except for cured cervical&#xD;
             carcinoma in situ, non melanoma of the skin;&#xD;
&#xD;
          -  Uncontrolled systemic infection requiring anti-infective treatment;&#xD;
&#xD;
          -  Allergies to chemotherapeutic drugs or their excipients or intolerant patients;&#xD;
&#xD;
          -  Subjects with ≥2 grade peripheral neuropathy according to CTCAE V 4.03;&#xD;
&#xD;
          -  Researchers think it is not suitable for enrolling.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Women's Hospital School Of Medicine Zhejiang University</name>
      <address>
        <city>Zhejiang</city>
        <state>Hangzhou</state>
        <zip>310006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>July 14, 2022</last_update_submitted>
  <last_update_submitted_qc>July 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Women's Hospital School Of Medicine Zhejiang University</investigator_affiliation>
    <investigator_full_name>Xing Xie</investigator_full_name>
    <investigator_title>Dean of Women's Hospital School Of Medicine Zhejiang University</investigator_title>
  </responsible_party>
  <keyword>PEGylated Doxorubicin Hydrochloride Liposome Injection</keyword>
  <keyword>Duomeisu</keyword>
  <keyword>First-line treatment</keyword>
  <keyword>Epithelial Ovarian Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Doxorubicin</mesh_term>
    <mesh_term>Liposomal doxorubicin</mesh_term>
  </intervention_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/NCT03794778
org study id: 20180148
nct id: NCT03794778
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a randomized, multicenter, open, controlled Post-Marketing Study. 396 patients who
      were histopathology or exfoliated cell pathology of pleural and ascites confirmed with
      epithelial ovarian cancer/fallopian tube/peritoneal cancer were enrolled in this study. The
      subjects will be randomly assigned to one of the two treatment groups at a 1: 1 ratio, and
      the stratification factors included: chemotherapy type (adjuvant chemotherapy/neoadjuvant
      chemotherapy), residual disease after surgery (>1cm, <1cm, no primary surgery), stage (Ic,
      II, III or IV), pathological typing, Eastern Cooperative Oncology Group performance status (0
      to 1 or 2), BRCA1/2 gene mutation.
Subjects will receive one of two treatment regimens:

      Group A: intravenous infusion of liposomal doxorubicin 30 mg/m2, d1; carboplatin AUC 5 (dosed
      according to the Calvert formula, with creatinine clearance estimated according to the
      Cockcroftformula), intravenous infusion, d1; once every 21days, 3~6 cycles for early stage
      patients and 6 cycles for late stage.

      Group B: intravenous infusion of paclitaxel 175 mg/m2, d1; carboplatin AUC 5, intravenous
      infusion, d1; once every 21days, 3~6 cycles for early stage patients and 6 cycles for late
      stage. Treatment was initially administered for three cycles, and patients with stable or
      responding disease continued treatment for further a three cycles.

      The main purpose is to evaluate the efficacy and safety of liposomal doxorubicin plus
      carboplatin in the first-line treatment of epithelial ovarian cancer. The primary endpoint is
      progression free survival (PFS), the secondary endpoints include overall survival (OS),
      objective response rate (ORR), disease control rate (DCR):CR+PR+SD, the incidence and
      severity of adverse reactions and health-related quality of life (HQL) assessment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PFS
time frame: From date of randomization until the date of first documented progression or death from any cause, whichever occurred first, or last follow-up for patients alive without progression, assessed up to approximately 36 months.
description: PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first.
measure: OS
time frame: From date of randomization until the date of death from any cause, or date of last follow-up for patients still alive, assessed up to 36 months
description: overall survival
measure: ORR
time frame: From date of randomization until PD or death from any cause, assessed up to 36 months.
description: ORR is defined as the rate of CR or PR, as determined by IRC using RECIST v1.1 criteria among patients with at least one target lesion. Activity was also described in women with nontarget lesions only and in women without any tumor lesion but with elevated CA-125 levels before starting treatment.
measure: DCR
time frame: From date of randomization until PD or death from any cause, assessed up to 36 months.
description: DCR is defined as the rate of of CR, PR, or stable disease according to RECIST v1.1.
measure: the incidence and severity of adverse reactions
time frame: A summary of adverse events of each cycle,from date of administration of drugs until 30 days after the last chemotherapy or progression,whichever came first,assessed up to 36 months.
description: Evaluate the adverse reactions rate of drugs assessed by number and severity of adverse events in the treatment.
measure: quality of life assessment
time frame: It will be assessed at baseline and before the administration of drugs at each first day of every two chemotherapy cycles, up to 6 cycles,each cycle is 21 days.
description: according to the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30).The basic content of life quality assessment includes: physical health, mental health, social function, disease status and overall health perception.
arm group label: study group
arm group type: Experimental
description: pegylated liposomal doxorubicin 30 mg/m2, i.v.,d1; carboplatin AUC 5,i.v.,d1; once every 21days, 3~6 cycles for early stage patients and 6 cycles for late stage.
arm group label: chemotherapy
arm group type: Active Comparator
description: paclitaxel 175 mg/m2, i.v.,d1; carboplatin AUC 5, i.v.,d1; once every 21days, 3~6 cycles for early stage patients and 6 cycles for late stage.
intervention type: Drug
intervention name: pegylated liposomal doxorubicin
description: PLD 30 mg/m2, i.v.,d1; once every 21days
arm group label: study group
other name: duomeisu
intervention type: Drug
intervention name: paclitaxel
description: paclitaxel 175 mg/m2, i.v.,d1; once every 21days
arm group label: chemotherapy
other name: zishanchun
intervention type: Drug
intervention name: Carboplatin
description: carboplatin AUC 5, i.v.,d1; once every 21days,
arm group label: chemotherapy
arm group label: study group
other name: kabo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Women's Hospital School Of Medicine Zhejiang University
investigator full name: Xing Xie
investigator title: Dean of Women's Hospital School Of Medicine Zhejiang University
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Paclitaxel
mesh term: Carboplatin
mesh term: Doxorubicin
mesh term: Liposomal doxorubicin
sharing ipd: No