<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/NCT03019315</url>
  </required_header>
  <id_info>
    <org_study_id>201310006RIND</org_study_id>
    <nct_id>NCT03019315</nct_id>
  </id_info>
  <brief_title>The Analyses of Treatment Efficacy and Cost-effectiveness in Early-staged Ovarian Cancer Patients</brief_title>
  <official_title>The Analyses of Treatment Efficacy and Cost-effectiveness in Early-staged Ovarian Cancer Patients Treated With or Without Paclitaxel Regimens</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adjuvant chemotherapy was introduced in patients with early-stage ovarian cancer. The benefit&#xD;
      of standard chemotherapeutic regimens including taxane has not been established. This study&#xD;
      was conducted to investigate the influences of regimens of front-line chemotherapy on on&#xD;
      recurrence and survival for early-stage ovarian adenocarcinoma. Further, the study will&#xD;
      analyze cost-effectiveness of different regimens&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ovarian carcinoma has become more and more important in recent years because it is the&#xD;
      leading cause of death among all gynecologic malignancies. The annual incidence rate of&#xD;
      ovarian cancer in the United States was 11.8 per 100,000 and the death rate was 7.8 per&#xD;
      100,000 in 2009. According to the Department of Health Bureau's report, the incidence rate of&#xD;
      ovarian cancer was 8.46 per 100,000 in 2010 and the death rate was 2.8 per 100,000. No&#xD;
      specific symptoms, difficulty in early diagnosis, insufficient accurate tumor markers, and a&#xD;
      lack of information regarding ovarian tumor biology all contribute to a poor prognosis.&#xD;
&#xD;
      The standard treatment for ovarian cancer is surgical tumor debulking, followed by&#xD;
      platinum-containing chemotherapy. The conventional adjuvant chemotherapeutic regimens of&#xD;
      ovarian cancer are platinum combined with cyclophosphamide. Whereas, platinum combined with&#xD;
      paclitaxel has been identified to be a better adjuvant chemotherapeutic regimens for those&#xD;
      advance-staged disease. In United States, platinum combined with paclitaxel has been used as&#xD;
      standard adjuvant chemotherapeutic regimens for all of ovarian cancer patients for decades.&#xD;
      However, many countries including Taiwan still use platinum combined with cyclophosphamide as&#xD;
      adjuvant chemotherapeutic regimens for early-staged ovarian cancer patients. There is no&#xD;
      comprehensive result to demonstrate the differences between these two regimens the fields of&#xD;
      efficacy, side effects, survival, cost-effectiveness, and so on. So the investigators conduct&#xD;
      this study to answer the questions. This study will firstly focus on the early-staged ovarian&#xD;
      cancer patients to analyze the data from the National Health Insurance (NHI) databank.&#xD;
      Further this study will then validate the results from NHI databank from the cancer&#xD;
      registration system of National Taiwan University Hospital.&#xD;
&#xD;
      There are several aims in this proposal. First, the study will evaluate the differences of&#xD;
      efficacy including the response rate, side effects, disease-free survival, and overall&#xD;
      survival of the patients between these two chemotherapeutic regimens. Second, the&#xD;
      cost-effectiveness of these two chemotherapeutic regimens will be identified. The results of&#xD;
      this study will provide a more comprehensive picture of selecting optimal chemotherapeutic&#xD;
      regimens for early-staged ovarian cancer patients. It can also be an important reference for&#xD;
      the pay-off of National Health Insurance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2015</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>progression free survival</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>over all survival</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>response rate</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Ovarian Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Ovarian cancer patients diagnosed between 1 January 1999 and 31 December 2020 without a&#xD;
        history of cancer were identified from the catastrophic illness registry.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) diagnosed at early stage, (2) treated with primary cytoreductive surgery followed&#xD;
             by adjuvant platinum based chemotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1)patients with a history of cancer (2)patients had insufficient clinic-pathological&#xD;
             and survival data regarding to disease prognosis&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wen-Fang Cheng, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Obstetrics and Gynecology, College of Medicine, National Taiwan University, Taipei, Taiwan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ying-Cheng Chiang, Ph.D.</last_name>
    <phone>886-2-2312-3456</phone>
    <phone_ext>71964</phone_ext>
    <email>littlechiang1878@yahoo.com.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wen-Fang Cheng, Ph.D.</last_name>
    <phone>886-2-2312-3456</phone>
    <phone_ext>71561</phone_ext>
    <email>wenfangcheng@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Taiwan University</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wen-Fang Cheng, Ph.D.</last_name>
      <phone>886-2-2312-3456</phone>
      <phone_ext>71561</phone_ext>
      <email>wenfangcheng@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 12, 2017</last_update_submitted>
  <last_update_submitted_qc>January 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ovarian Cancer</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>Response Rate</keyword>
  <keyword>Survival</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>
  <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/NCT03019315
org study id: 201310006RIND
nct id: NCT03019315
lead sponsor: 
has dmc: No
Adjuvant chemotherapy was introduced in patients with early-stage ovarian cancer. The benefit
      of standard chemotherapeutic regimens including taxane has not been established. This study
      was conducted to investigate the influences of regimens of front-line chemotherapy on on
      recurrence and survival for early-stage ovarian adenocarcinoma. Further, the study will
      analyze cost-effectiveness of different regimens
Ovarian carcinoma has become more and more important in recent years because it is the
      leading cause of death among all gynecologic malignancies. The annual incidence rate of
      ovarian cancer in the United States was 11.8 per 100,000 and the death rate was 7.8 per
      100,000 in 2009. According to the Department of Health Bureau's report, the incidence rate of
      ovarian cancer was 8.46 per 100,000 in 2010 and the death rate was 2.8 per 100,000. No
      specific symptoms, difficulty in early diagnosis, insufficient accurate tumor markers, and a
      lack of information regarding ovarian tumor biology all contribute to a poor prognosis.

      The standard treatment for ovarian cancer is surgical tumor debulking, followed by
      platinum-containing chemotherapy. The conventional adjuvant chemotherapeutic regimens of
      ovarian cancer are platinum combined with cyclophosphamide. Whereas, platinum combined with
      paclitaxel has been identified to be a better adjuvant chemotherapeutic regimens for those
      advance-staged disease. In United States, platinum combined with paclitaxel has been used as
      standard adjuvant chemotherapeutic regimens for all of ovarian cancer patients for decades.
      However, many countries including Taiwan still use platinum combined with cyclophosphamide as
      adjuvant chemotherapeutic regimens for early-staged ovarian cancer patients. There is no
      comprehensive result to demonstrate the differences between these two regimens the fields of
      efficacy, side effects, survival, cost-effectiveness, and so on. So the investigators conduct
      this study to answer the questions. This study will firstly focus on the early-staged ovarian
      cancer patients to analyze the data from the National Health Insurance (NHI) databank.
      Further this study will then validate the results from NHI databank from the cancer
      registration system of National Taiwan University Hospital.

      There are several aims in this proposal. First, the study will evaluate the differences of
      efficacy including the response rate, side effects, disease-free survival, and overall
      survival of the patients between these two chemotherapeutic regimens. Second, the
      cost-effectiveness of these two chemotherapeutic regimens will be identified. The results of
      this study will provide a more comprehensive picture of selecting optimal chemotherapeutic
      regimens for early-staged ovarian cancer patients. It can also be an important reference for
      the pay-off of National Health Insurance.
observational model: Cohort
measure: progression free survival
time frame: 5 years
measure: over all survival
time frame: 5 years
measure: response rate
time frame: 6 months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wen-Fang Cheng, Ph.D.
role: Principal Investigator
affiliation: Department of Obstetrics and Gynecology, College of Medicine, National Taiwan University, Taipei, Taiwan
last name: Ying-Cheng Chiang, Ph.D.
phone: 886-2-2312-3456
phone ext: 71964
email: littlechiang1878@yahoo.com.tw
last name: Wen-Fang Cheng, Ph.D.
phone: 886-2-2312-3456
phone ext: 71561
email: wenfangcheng@yahoo.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
sharing ipd: No