<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/NCT02980185</url>
  </required_header>
  <id_info>
    <org_study_id>541</org_study_id>
    <nct_id>NCT02980185</nct_id>
  </id_info>
  <brief_title>Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer</brief_title>
  <official_title>Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer: a Prospective Validation and Comparison With Open Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università degli Studi dell'Insubria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Università degli Studi dell'Insubria</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the feasibility, Residual Tumor, complication rate and survival of totally&#xD;
      laparoscopic primary cytoreduction in carefully selected patients with Advanced Ovarian&#xD;
      Cancer, compared with abdominal primary cytoreduction in a single-Institution, single-surgeon&#xD;
      prospective series.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients with presumed stage III-IV ovarian cancer and clinical conditions allowing&#xD;
      aggressive surgery were candidate to possible primary cytoreduction with the aim of achieving&#xD;
      residual tumor=0. A definite protocol was adopted: after radiological preoperative evaluation&#xD;
      with PET-CT scan, all patients underwent laparoscopic evaluation with the Fagotti score. Once&#xD;
      considered suitable for primary debulking surgery, the possibility of attempting laparoscopic&#xD;
      cytoreduction was carefully evaluated using strict selection criteria; patients were divided&#xD;
      in two groups, based on the type of surgical approach. At the end of laparoscopic primary&#xD;
      cytoreduction, a ultra-low pubic minilaparotomy was performed to extract surgical specimens&#xD;
      and to perform laparoscopic hand-assisted exploration of the abdominal organs, in order to&#xD;
      ensure complete excision of the disease. Surgical data, optimal cytoreduction (defined as&#xD;
      residual tumor=0) rates and survival outcomes were investigated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2007</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Residual tumor at the end of surgery (using the completeness of cytoreduction score)</measure>
    <time_frame>June 2007 - July 2015</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease-free Survival</measure>
    <time_frame>June 2007 - July 2016</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>June 2007 - July 2016</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">66</enrollment>
  <condition>Residual Tumor</condition>
  <condition>Disease-free Survival</condition>
  <condition>Overall Survival</condition>
  <arm_group>
    <arm_group_label>Laparoscopic primary cytoreduction</arm_group_label>
    <description>Patients in whom primary cytoreduction was performed using a laparoscopic approach</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Abdominal primary cytoreduction</arm_group_label>
    <description>Patients in whom primary cytoreduction was performed using an open abdominal approach</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic primary cytoreduction</intervention_name>
    <description>Primary cytoreduction for ovarian cancer performed through a completely minimally-invasive approach</description>
    <arm_group_label>Laparoscopic primary cytoreduction</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing primary cytoreduction for stage III-IV ovarian cancer at the Sacred&#xD;
        Heart Hospital, Negrar, Italy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary Ovarian cancer&#xD;
&#xD;
          -  Epithelial histotype&#xD;
&#xD;
          -  Stage III-IV disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anesthesiological contraindication to primary cytoreduction&#xD;
&#xD;
          -  Extension of disease contraindicating primary cytoreduction&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefano Uccella, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Università degli Studi dell'Insubria</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology Universita' Dell'Insubria</name>
      <address>
        <city>Varese</city>
        <zip>21100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Nezhat FR, DeNoble SM, Liu CS, Cho JE, Brown DN, Chuang L, Gretz H, Saharia P. The safety and efficacy of laparoscopic surgical staging and debulking of apparent advanced stage ovarian, fallopian tube, and primary peritoneal cancers. JSLS. 2010 Apr-Jun;14(2):155-68. doi: 10.4293/108680810X12785289143990.</citation>
    <PMID>20932362</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 26, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>November 29, 2016</last_update_submitted>
  <last_update_submitted_qc>November 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Università degli Studi dell'Insubria</investigator_affiliation>
    <investigator_full_name>Stefano Uccella</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm, Residual</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/NCT02980185
org study id: 541
nct id: NCT02980185
lead sponsor: 
has dmc: No
To assess the feasibility, Residual Tumor, complication rate and survival of totally
      laparoscopic primary cytoreduction in carefully selected patients with Advanced Ovarian
      Cancer, compared with abdominal primary cytoreduction in a single-Institution, single-surgeon
      prospective series.
All patients with presumed stage III-IV ovarian cancer and clinical conditions allowing
      aggressive surgery were candidate to possible primary cytoreduction with the aim of achieving
      residual tumor=0. A definite protocol was adopted: after radiological preoperative evaluation
      with PET-CT scan, all patients underwent laparoscopic evaluation with the Fagotti score. Once
      considered suitable for primary debulking surgery, the possibility of attempting laparoscopic
      cytoreduction was carefully evaluated using strict selection criteria; patients were divided
      in two groups, based on the type of surgical approach. At the end of laparoscopic primary
      cytoreduction, a ultra-low pubic minilaparotomy was performed to extract surgical specimens
      and to perform laparoscopic hand-assisted exploration of the abdominal organs, in order to
      ensure complete excision of the disease. Surgical data, optimal cytoreduction (defined as
      residual tumor=0) rates and survival outcomes were investigated.
observational model: Cohort
time perspective: Prospective
measure: Residual tumor at the end of surgery (using the completeness of cytoreduction score)
time frame: June 2007 - July 2015
measure: Disease-free Survival
time frame: June 2007 - July 2016
measure: Overall Survival
time frame: June 2007 - July 2016
arm group label: Laparoscopic primary cytoreduction
description: Patients in whom primary cytoreduction was performed using a laparoscopic approach
arm group label: Abdominal primary cytoreduction
description: Patients in whom primary cytoreduction was performed using an open abdominal approach
intervention type: Procedure
intervention name: Laparoscopic primary cytoreduction
description: Primary cytoreduction for ovarian cancer performed through a completely minimally-invasive approach
arm group label: Laparoscopic primary cytoreduction
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Stefano Uccella, MD, PhD
role: Study Chair
affiliation: Università degli Studi dell'Insubria
facility: 
country: Italy
citation: Nezhat FR, DeNoble SM, Liu CS, Cho JE, Brown DN, Chuang L, Gretz H, Saharia P. The safety and efficacy of laparoscopic surgical staging and debulking of apparent advanced stage ovarian, fallopian tube, and primary peritoneal cancers. JSLS. 2010 Apr-Jun;14(2):155-68. doi: 10.4293/108680810X12785289143990.
PMID: 20932362
responsible party type: Principal Investigator
investigator affiliation: Università degli Studi dell'Insubria
investigator full name: Stefano Uccella
investigator title: Doctor
mesh term: Neoplasm, Residual
sharing ipd: No