<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/NCT04491643</url>
  </required_header>
  <id_info>
    <org_study_id>53211029-02</org_study_id>
    <nct_id>NCT04491643</nct_id>
  </id_info>
  <brief_title>Megestrol Acetate Plus Rosuvastatin in Young Women With Early Endometrial Carcinoma</brief_title>
  <official_title>Megestrol Acetate Plus Rosuvastatin in Young Women With Early Endometrial Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To explore the treatment efficacy of megestrol acetate plus rosuvastatin in patients with&#xD;
      early endometrial carcinoma (EEC) seeking for conservative treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After diagnosed of EEC by hysteroscopy, patients meet the study criteria will be enrolled.&#xD;
      Age, height, weight, waist circumstances, blood pressure, basic history of infertility and&#xD;
      blood pressure will be collected. Blood tests, including fasting blood glucose (FBG), fasting&#xD;
      insulin (FINS), OGTT 2h blood glucose and insulin, blood lipids, SHBG, sex hormone levels,&#xD;
      anti-müllerian hormone(AMH), creatine kinase(CK) and renal/liver function tests will be&#xD;
      performed before treatment to evacuate their basic conditions. Each subject will receive body&#xD;
      fat testing by Inbody 520.&#xD;
&#xD;
      Patients will receive MA (megestrol acetate) 160 mg by mouth daily plus rosuvastatin 10mg by&#xD;
      mouth daily for at least 6 months. Then hysteroscopy will be used to evaluate the endometrial&#xD;
      condition every 3 months, and intra-operative findings will be recorded. Complete response&#xD;
      (CR) is defined as the reversion of endometrial atypical hyperplasia to proliferative or&#xD;
      secretory endometrium; partial response (PR) is defined as regression to hyperplasia with or&#xD;
      without atypic; stable disease (SD) is defined as the persistence of the disease; and&#xD;
      progressive disease (PD) is defined as the appearance of higher pathological progression, or&#xD;
      myometrial invasion, or extra-uterine metastasis. Continuous therapies will be needed in PR&#xD;
      or NR. Patients with PD will be recommended for hysterectomy.&#xD;
&#xD;
      Due to personal reasons, patients may not accept hysteroscopic evaluation every three months,&#xD;
      then the longest duration will be 8 months. For patients remained SD after 6 to 8 months of&#xD;
      treatment but refused hysterectomy, a multiple disciplinary discussion would be held for&#xD;
      individual case, and alternative treatment would be given.&#xD;
&#xD;
      Two months of maintenance treatment will be recommended for patients with CR, and&#xD;
      participants will be followed up for 2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2023</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>
    <intervention_model_description>Simon two-stage optimal design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pathological response rate</measure>
    <time_frame>12 to 16 weeks</time_frame>
    <description>From date of initial therapy until the date of CR or date of hysterectomy, whichever come first, assessed up to 16 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pathological response rate</measure>
    <time_frame>28 to 32 weeks</time_frame>
    <description>From date of initial therapy until the date of CR or date of hysterectomy, whichever come first, assessed up to 32 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pathological response duration</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Pathological response duration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pathological response rate classified by different blood lipid level</measure>
    <time_frame>up to 32 weeks</time_frame>
    <description>Pathological response rate classified by different blood lipid level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Toxicity evaluation</measure>
    <time_frame>up to 32 weeks</time_frame>
    <description>Toxicity evaluation according to CTCAE 5.0 version.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse rate</measure>
    <time_frame>Up to 2 years after the end of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pregnancy rate</measure>
    <time_frame>Up to 2 years after the end of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Endometrial Carcinoma Stage I</condition>
  <arm_group>
    <arm_group_label>MA + Rosuvastatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive MA 160 mg and rosuvastatin 10 mg by mouth daily for at least 6 months. Then every 3 months, hysteroscopy will be used to evaluate the endometrial condition, and findings will be recorded.&#xD;
Due to personal reasons, patients may not accept hysteroscopic evaluation every three months, then the longest duration will be 8 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Megestrol Acetate</intervention_name>
    <description>At a dosage of 160 mg/day</description>
    <arm_group_label>MA + Rosuvastatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin</intervention_name>
    <description>At a dosage of 10 mg/day</description>
    <arm_group_label>MA + Rosuvastatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a confirmed pathological diagnosis based upon hysteroscopy: histologically prove&#xD;
             well-differentiated EEC G1 without myometrial invasion&#xD;
&#xD;
          -  No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging&#xD;
             (MRI) or enhanced computed tomography (CT) or ultrasound&#xD;
&#xD;
          -  Have a desire for remaining reproductive function or uterus&#xD;
&#xD;
          -  Good compliance with adjunctive treatment and follow-up&#xD;
&#xD;
          -  Abnormal blood lipid. At least meet one of the following five items:&#xD;
&#xD;
               1. Total cholesterol (TC) ≥ 5.2mmol/L (200mg/dL)&#xD;
&#xD;
               2. Low-density lipoprotein cholesterol (LDL-C) ≥ 3.4mmol/L (130mg/dL)&#xD;
&#xD;
               3. Fasting triglycerides (TG) ≥ 1.7mmol/L (150mg/dL)&#xD;
&#xD;
               4. High-density lipoprotein cholesterol (HDL-C) #1.03mmol/L (40mg/dL)&#xD;
&#xD;
               5. Apo-lipoprotein-A (Apo-A) ≥ 1.0g/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute liver disease or liver tumor (benign or malignant) or renal dysfunction&#xD;
&#xD;
          -  Pregnancy or potential pregnancy&#xD;
&#xD;
          -  Under treatment of high-dose progestin therapy more than 1 months in recent 6 months&#xD;
&#xD;
          -  Confirmed diagnosis of any cancer in reproductive system&#xD;
&#xD;
          -  Acute severe disease such as stroke or heart infarction or a history of thrombosis&#xD;
             disease&#xD;
&#xD;
          -  Hypersensitivity or contradiction for using MA or atorvastatin&#xD;
&#xD;
          -  Already diagnosed with hyperlipidemia and using lipid-lowering drugs&#xD;
&#xD;
          -  With other factors of reproductive dysfunction;&#xD;
&#xD;
          -  Strong request for uterine removal or other conservative treatment&#xD;
&#xD;
          -  Smoker (&gt;15 cigarettes a day)&#xD;
&#xD;
          -  Drinker (&gt;20 grams a day)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaojun Chen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Obstetrics and Gynecology Hospital, Fudan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaojun Chen, PhD</last_name>
    <phone>862163455050</phone>
    <email>cxjlhjj@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bingyi Yang, MD</last_name>
    <phone>862163455050</phone>
    <email>xiaomihaoku@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Obstetrics and Gynecology Hospital, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaojun Chen</last_name>
      <email>cxjlhjj@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>February 16, 2023</last_update_submitted>
  <last_update_submitted_qc>February 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Obstetrics &amp; Gynecology Hospital of Fudan University</investigator_affiliation>
    <investigator_full_name>Xiaojun Chen</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <keyword>megestrol acetate</keyword>
  <keyword>rosuvastatin</keyword>
  <keyword>endometrial carcinoma stage I limited to endometrium</keyword>
  <keyword>conservative treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Endometrial Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Megestrol</mesh_term>
    <mesh_term>Megestrol Acetate</mesh_term>
    <mesh_term>Rosuvastatin Calcium</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/NCT04491643
org study id: 53211029-02
nct id: NCT04491643
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To explore the treatment efficacy of megestrol acetate plus rosuvastatin in patients with
      early endometrial carcinoma (EEC) seeking for conservative treatment.
After diagnosed of EEC by hysteroscopy, patients meet the study criteria will be enrolled.
      Age, height, weight, waist circumstances, blood pressure, basic history of infertility and
      blood pressure will be collected. Blood tests, including fasting blood glucose (FBG), fasting
      insulin (FINS), OGTT 2h blood glucose and insulin, blood lipids, SHBG, sex hormone levels,
      anti-müllerian hormone(AMH), creatine kinase(CK) and renal/liver function tests will be
      performed before treatment to evacuate their basic conditions. Each subject will receive body
      fat testing by Inbody 520.

      Patients will receive MA (megestrol acetate) 160 mg by mouth daily plus rosuvastatin 10mg by
      mouth daily for at least 6 months. Then hysteroscopy will be used to evaluate the endometrial
      condition every 3 months, and intra-operative findings will be recorded. Complete response
      (CR) is defined as the reversion of endometrial atypical hyperplasia to proliferative or
      secretory endometrium; partial response (PR) is defined as regression to hyperplasia with or
      without atypic; stable disease (SD) is defined as the persistence of the disease; and
      progressive disease (PD) is defined as the appearance of higher pathological progression, or
      myometrial invasion, or extra-uterine metastasis. Continuous therapies will be needed in PR
      or NR. Patients with PD will be recommended for hysterectomy.

      Due to personal reasons, patients may not accept hysteroscopic evaluation every three months,
      then the longest duration will be 8 months. For patients remained SD after 6 to 8 months of
      treatment but refused hysterectomy, a multiple disciplinary discussion would be held for
      individual case, and alternative treatment would be given.

      Two months of maintenance treatment will be recommended for patients with CR, and
      participants will be followed up for 2 years.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Simon two-stage optimal design
primary purpose: Treatment
masking: None (Open Label)
measure: Pathological response rate
time frame: 12 to 16 weeks
description: From date of initial therapy until the date of CR or date of hysterectomy, whichever come first, assessed up to 16 weeks.
measure: Pathological response rate
time frame: 28 to 32 weeks
description: From date of initial therapy until the date of CR or date of hysterectomy, whichever come first, assessed up to 32 weeks.
measure: Pathological response duration
time frame: up to 2 years
description: Pathological response duration
measure: Pathological response rate classified by different blood lipid level
time frame: up to 32 weeks
description: Pathological response rate classified by different blood lipid level
measure: Toxicity evaluation
time frame: up to 32 weeks
description: Toxicity evaluation according to CTCAE 5.0 version.
measure: Relapse rate
time frame: Up to 2 years after the end of treatment
measure: Pregnancy rate
time frame: Up to 2 years after the end of treatment
arm group label: MA + Rosuvastatin
arm group type: Experimental
description: Patients will receive MA 160 mg and rosuvastatin 10 mg by mouth daily for at least 6 months. Then every 3 months, hysteroscopy will be used to evaluate the endometrial condition, and findings will be recorded.
Due to personal reasons, patients may not accept hysteroscopic evaluation every three months, then the longest duration will be 8 months.
intervention type: Drug
intervention name: Megestrol Acetate
description: At a dosage of 160 mg/day
arm group label: MA + Rosuvastatin
intervention type: Drug
intervention name: Rosuvastatin
description: At a dosage of 10 mg/day
arm group label: MA + Rosuvastatin
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Xiaojun Chen, PhD
role: Principal Investigator
affiliation: Obstetrics and Gynecology Hospital, Fudan University
last name: Xiaojun Chen, PhD
phone: 862163455050
email: cxjlhjj@163.com
last name: Bingyi Yang, MD
phone: 862163455050
email: xiaomihaoku@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Obstetrics & Gynecology Hospital of Fudan University
investigator full name: Xiaojun Chen
investigator title: Principle investigator
mesh term: Carcinoma
mesh term: Endometrial Neoplasms
mesh term: Megestrol
mesh term: Megestrol Acetate
mesh term: Rosuvastatin Calcium